Top PDF Effect of etelcalcetide on cardiac hypertrophy in hemodialysis patients: a randomized controlled trial (ETECAR HD)

Effect of etelcalcetide on cardiac hypertrophy in hemodialysis patients: a randomized controlled trial (ETECAR HD)

Effect of etelcalcetide on cardiac hypertrophy in hemodialysis patients: a randomized controlled trial (ETECAR HD)

550 ACE: Angiotensin-converting enzyme; AE: Adverse event; ALFA: Alfacalcidol; 551 Ang: Angiotensin; BCM: Body composition monitoring; BNP: Brain natriuretic 552 peptide; CKD: Chronic kidney disease; cMRI: Cardiac magnetic resonance 553 imaging; ETL: Etelcalcetide; FGF: Fibroblast growth factor; FGFR: Fibroblast 554 growth factor receptor; LVH: Left ventricular hypertrophy; LVM/BSA: Left 555 ventricular mass indexed for body surface area; LVMI: Left ventricular mass 556 index; PTH: Parathyroid hormone; RAAS: Renin – angiotensin – aldosterone 557 system; sHPT: Secondary hyperparathyroidism; SUSAR: Suspected unexpected 558 serious adverse reaction; TnT: Troponin T
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Effect of bixalomer on coronary artery calcification in hemodialysis patients with hyperphosphatemia: a multi-center, randomized controlled trial

Effect of bixalomer on coronary artery calcification in hemodialysis patients with hyperphosphatemia: a multi-center, randomized controlled trial

Continuous variables are presented as mean ± standard devi- ation (SD) and frequency variables as the number of cases and percentages. Comparisons between groups were con- ducted using the parametric method (i.e., unpaired t test) if a normal distribution was confirmed. Changes from baseline over time were compared using the paired t test if a normal distribution was confirmed. Between-group comparisons in frequency variables were performed using Fisher’s exact test or the chi-square test. The Wilcoxon rank sum test for con- tinuous variables was used if a normal distribution was not confirmed. Measured values of discontinued and withdrawn cases were included in the analysis up until discontinuation/ withdrawal if they had been collected after starting the trial. Missing values were not imputed. All probability values were two-tailed. P values < 0.05 were considered statistically sig- nificant. All analyses were conducted using SAS 9.3 (Cary, NC, USA). Statistical analyses of the present study were per- formed by Meditrix Corporation, Tokyo, Japan.
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Effect of perioperative sodium bicarbonate administration on renal function following cardiac surgery for infective endocarditis: a randomized, placebo controlled trial

Effect of perioperative sodium bicarbonate administration on renal function following cardiac surgery for infective endocarditis: a randomized, placebo controlled trial

The systemic inflammation and oxidative stress associ- ated with septic conditions predispose patients with IE undergoing cardiac surgery to AKI [5]. Furthermore, prolonged use of nephrotoxic antibiotics preoperatively, and administration of contrast media shortly before car- diac surgery, adds to the risk of AKI by enhancing proin- flammatory oxidative stress [16, 24]. Sodium bicarbonate administration produces blood and urine alkalization and may slow pH-dependent Haber-Weiss free-radical production, thereby attenuating reactive oxygen species- mediated tubular injury [11, 24, 25]. Sodium bicarbonate may also directly scavenge other reactive species [26]. Tubular alkalosis achieved by sodium bicarbonate has been demonstrated to mitigate the conversion of hemoglobin to methemoglobin, preventing tubular obstruction and tubu- lar cell necrosis [10]. Accordingly, sodium bicarbonate ad- ministration has shown benefits in experimental models of ischemic [27], doxorubicin-induced [28], and contrast- medium-induced AKI [29]. However, several trials and meta-analyses investigating the renal effects of sodium bicarbonate in the context of cardiac surgery yielded Table 2 Incidence of postoperative acute kidney injury, serum creatinine level and glomerular filtration rate
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Effect of Using Eye Mask on Sleep Quality in Cardiac Patients: A Randomized Controlled Trial

Effect of Using Eye Mask on Sleep Quality in Cardiac Patients: A Randomized Controlled Trial

Sleep is a basic need for the human beings. High qual- ity sleep is associated with better recovery from diseases (1). Sleep disorders are common in patients hospitalized in Coronary Care Units (CCU) (2). These disorders are associated with environmental factors such as noises, intervention-related pain and discomfort. Moreover, the psychological stress of having a life-threatening disease and disease complications may put patients at risk for de- velopment of sleep disorders (2, 3). The results of a study conducted in Shahrekord, Iran showed that about 51% of patients with congestive heart failure suffer from sleep disorders (4).
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Influence of volatile anesthesia versus total intravenous anesthesia on chronic postsurgical pain after cardiac surgery using the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials criteria: study protocol for a prospective randomi

Influence of volatile anesthesia versus total intravenous anesthesia on chronic postsurgical pain after cardiac surgery using the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials criteria: study protocol for a prospective randomized controlled trial

Patients undergoing cardiac surgery need general anesthesia from either intravenous (IV) anesthetics (such as propofol) or volatile anesthetics (such as isoflurane, sevoflurane, and desflurane). Studies have found that propofol has anti-inflammatory and antioxidative effects on the biosynthesis of cytokines, which are important in pain signaling [13]. Propofol’s ability to scavenge free radicals is useful and important. It has antioxidant prop- erties and may also dynamically protect the body [14]. Moreover, propofol can modulate NMDA receptors in neurons in vivo, which play a crucial role in the trans- mission and maintenance of the pain signaling pathway [14, 15]. These anti-inflammatory, free radical scaven- ging, and NMDA receptor antagonistic properties of propofol imply that it may have a possible perioperative analgesic effect. The meta-analyses by Qiu et al. and Peng et al. suggest that propofol improved postoperative analgesia compared with inhalational anesthesia [16, 17]. However, most previous studies were not designed to de- tect differences in chronic pain [16, 17], and a few clinical trials investigating CPSP focused on non-cardiac surgery [18, 19]. To date, no published clinical trial has compared the effects of volatile anesthesia with those of propofol- based total intravenous anesthesia (TIVA) in preventing CPSP after cardiac surgery through sternotomy.
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The VITAH Trial Vitamin D supplementation and cardiac autonomic tone in hemodialysis: a blinded, randomized controlled trial

The VITAH Trial Vitamin D supplementation and cardiac autonomic tone in hemodialysis: a blinded, randomized controlled trial

levels are associated with vascular physiology that increases cardiovascular risk [35], but also that poor vitamin D status is associated with an impaired ability to maintain cardiac autonomic tone in response to endogen- ous angiotensin II in healthy humans [36], a hormone that is chronically upregulated in the ESKD population. Furthermore, we have also demonstrated that vitamin D supplementation is associated with normalization of autonomic tone in response to an acute angiotensin II stressor in healthy subjects [37]. As vagal activity is markedly reduced in hemodialysis patients [15], it is possible that vitamin D supplementation could im- prove the cardiac autonomic response to stressors such as hemodialysis. Regardless, the impact of vitamin D therapy in the ESKD population, and on other surrogate clinical measures of cardiovascular risk has not been assessed. In an observational study, serum 25OHD pre- dicted total and cardiovascular mortality in incident ESKD patients, but this association was abolished in patients provided therapy with calcitriol or its active analogues [26]. This novel observation suggests that intensive vitamin D therapy inclusive of 1,25-dihydroxyvitamin D 3 analogues as well as other vitamin D derivatives
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Comparing the effect of aromatherapy with peppermint and lavender on the sleep quality of cardiac patients: a randomized controlled trial

Comparing the effect of aromatherapy with peppermint and lavender on the sleep quality of cardiac patients: a randomized controlled trial

After obtaining permission from the authorities of Imam Ali Hospital, sampling was conducted in the CCU. This hospital is the largest cardiology center in west of Iran. The CCU ward of the hospital consisted of single-bed rooms separated by curtains. First, eligible subjects were included in the study by convenience sampling and then randomly assigned to the intervention and control groups via block randomization. In the intervention groups, inhalation aromatherapy was performed using 100% pure peppermint or lavender essential oil. On the other hand, aromatic distilled water was used for the control group. In the aromatherapy groups using peppermint and lavender essential oils, three drops of each essential oil were smeared on a napkin, which was attached to a collar for 20 min at 9:00 pm. The same procedure was applied for the control group using three drops of aromatic distilled water. The duration of the intervention was seven nights, and PSQI was completed by all participants before the intervention (on the first night) and on the eighth day (in the morning). It should be noted that the researcher made every effort to keep the possible effects of environmental factors, such as light and noise, on the patients’ sleep quality to a mini- mum. The study process is shown in Fig. 1.
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Effect of liraglutide on cardiac function in patients with type 2 diabetes mellitus: randomized placebo-controlled trial

Effect of liraglutide on cardiac function in patients with type 2 diabetes mellitus: randomized placebo-controlled trial

Ea by reducing cardiac preload. Second, the increase in heart rate could have affected LV diastolic filling pat- tern directly [22]. However, there are two reasons why we do not expect increased heart rate to be the causa- tive effect of diastolic filling pattern changes: 1. the change in heart rate is relatively small in comparison to change in early filling; 2. a study in HFpEF patients using the selective sino-atrial node blocker ivabradine did not change E/Ea [23]. Lastly, a direct effect of GLP-1RA on the heart has been proposed as a mechanism to improve cardiac energy metabolism and thereby cardiac func- tion. Although GLP-1 receptor is expressed in cardio- myocytes, to date it is uncertain what its exact function in humans is [24]. However, if liraglutide had improved myocardial relaxation, an increase in Ea would have been expected. Ea however did not change significantly, which suggests against a direct effect of liraglutide on cardiomy- ocyte relaxation properties. It is unlikely that weight loss explains the observed effect of liraglutide on LV diastolic function, because a previous study from our group [25] has shown that calorie restriction with significant weight loss increased E/A ratio probably as a result of improved LV relaxation and/or filling properties (since LV filling pressure remained unchanged). Another important car- diovascular effect of weight loss in the study by Hammer et  al. was a significant decline in heart rate, which is a consistent finding in patients after weight loss. Therefore, the rise in heart rate in the present study is in keeping
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The effect of empowerment on the self-efficacy, quality of life and clinical and laboratory indicators of patients treated with hemodialysis: a randomized controlled trial

The effect of empowerment on the self-efficacy, quality of life and clinical and laboratory indicators of patients treated with hemodialysis: a randomized controlled trial

Although measurement of blood pressure was done by a trained nurse, two points must be considered regar- ding reliability of the results. First, we measured pre- dialysis blood pressures, which have been reported to be biased estimates of systolic and diastolic blood pressure by a variable amount. Pre-dialysis measurements could be higher because of increased intravascular volume, withholding antihypertensive medications immediately prior to treatment, white coat syndrome, and lack of standardized measurements [45]. Secondly, the possibi- lity of overestimation (50 mmHg) or underestimation (20 mmHg) of blood pressure as stated by Saint-Remy and Krzesinski existed. These researchers have cautioned medical professionals about the consideration of blood pressure measurements in the HD unit as quantitative and propose that such readings be a qualitative indicator of control (or lack of control) [43]. Ambulatory blood pressure monitoring or self-measurement by patients using home blood pressure monitoring has been sug- gested in different studies as reflective of a better va- lidated measure of blood pressure [46,47]. However, regarding the suggested approaches for blood pressure control in HD patients, first by slow and smooth re- moval of extracellular volume (dry weight) and there- after by appropriate antihypertensive medication [30], the possible effect of the intervention on medication ad- herence should not be ignored.
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The Effect of Massage With Lavender Oil on Restless Leg Syndrome in Hemodialysis Patients: A Randomized Controlled Trial

The Effect of Massage With Lavender Oil on Restless Leg Syndrome in Hemodialysis Patients: A Randomized Controlled Trial

Restless leg syndrome (RLS) or the Willis-Ekbom disease is a neurological disorder characterized by a compulsory need to move legs (1). Patients with this syndrome, expe- rience an intensely uncomfortable sensation in their legs that compels them to move their legs involuntarily (2). Patients with RLS usually experience several complica- tions including reduced quality of life (QOL) and sleep disturbances (3, 4). After mental disorders, drug abuse, and breathing-related sleep disorders, RLS is the fourth- leading cause of insomnia (5). Although RLS is not as life threatening as diabetes or cardiac disorders, it is crucial to be treated, because it results in chronic insomnia and daytime drowsiness that consequently decreases patient’s QOL (6). Patients with chronic renal insufficiency who un- dergo hemodialysis may commonly encounter various complications including RLS, which might be experienced frequently (7). Approximately 20 - 80% of hemodialysis pa- tients experience RLS, while its prevalence in general popu- lation is 2 to 15% (8, 9). International restless leg syndrome study group has identified four main criteria for diagnosis of RLS including: a) urge to move the legs, usually accom- panied by discomfort in legs, b) start or exacerbation of symptoms at rest or after inactivity, c) complete or partial
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Auricular acupressure for insomnia in hemodialysis patients: study protocol for a randomized controlled trial

Auricular acupressure for insomnia in hemodialysis patients: study protocol for a randomized controlled trial

There are several limitations of this study. First, sleep quality is not assessed by objective measurement such as polysomnography or actigraphy. There are some difficul- ties for us to perform these tests. Most hemodialysis patients refused to go through polysomnography in our pilot studies when they were required to stay a whole night in hospital. Actigraphy seems easily accepted but this equipment is unavailable in all centers. Due to limited financial support, we have to make the best of a well-acknowledged scale to assess the outcome. In a future study, actigraphy should be included. Second, anxiety and depression are commonly accompanied with sleep disorders but are not assessed in this study. Recent study has suggested that they have positive correla- tions with PSQI score [43]. A more comprehensive assess- ment of the effect of auricular acupressure will include sleep quality, anxiety and depression, and quality of life in future study.
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A Comparative study on the effects of vitamin C and Pramipexole on restless legs syndrome treatment in hemodialysis patients: A randomized, doubleblind, placebo-controlled trial

A Comparative study on the effects of vitamin C and Pramipexole on restless legs syndrome treatment in hemodialysis patients: A randomized, doubleblind, placebo-controlled trial

Restless leg syndrome (RLS) is a neurological movement disorder defined by an unpleasant sensation in the legs, especially during sitting and lying down. The aim of this study was to evaluate the effect of vitamin C and comparing it with that of pramipexole in the treatment of RLS in patients undergoing hemodialysis. This double- blind clinical trial was performed on 45 patients undergoing hemodialysis and met the diagnostic criteria proposed by the International Restless Leg Syndrome Study Group (IRLSSG) for RLS diagnosis. Patients were divided in three groups: pramipexole, vitamin C, and placebo, and received drugs daily for 8 weeks. Prior to the initiation and after the completion of the experiment, the scoring questionnaire of the IRLSSG was completed for all the patients.Before and after the intervention, the IRLS score in the three groups of vitamin C, pramipexole and placebo were 24.73±7.06 and 12.20±5.95( p <0.001), 26.83±7.51 and 13.71±4.32( p <0.001), and 23.20±6.73 and 21.27±7.13. (p= 0.002).The three groups were not significantly different with regard to the IRLS scores prior to the intervention (p=0.005). However, the Tukey’s test demonstrated that the vitamin C and placebo groups and the pramipexole and placebo groups were significantly different regarding the IRLS scores obtained after the intervention (p<0.001), (p=0.004), and the pramipexole group was not statistically significantly different from the vitamin C group (p=0.77).Vitamin C was shown to be an inexpensive, safe and without serious adverse effects in short-term follow- up supplementation for treatment of RLS in hemodialysis patients.
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The NKF-NUS hemodialysis trial protocol - a randomized controlled trial to determine the effectiveness of a self management intervention for hemodialysis patients

The NKF-NUS hemodialysis trial protocol - a randomized controlled trial to determine the effectiveness of a self management intervention for hemodialysis patients

The trial design addresses weaknesses of previous research by use of an adequate sample size to detect clinically significant changes in biochemical markers, recruitment of a sufficiently large and representative haemodialysis sample, definition of a feasible theory based intervention to support treatment adherence, and careful assessment of both clinical and psychological endpoints in order to evaluate whether effects (if any) are sustained over time. Inclusion of multiple dependent variables allows us to assess the broader impact on the intervention including both hard end points as well as patient reported outcomes. A further strength of the trial design is the inclusion of measures that explore the extent to which the intervention impacts upon psycho- logical processes and how these processes act as mediat- ing variables. It will be possible to explore whether the intervention influences beliefs and cognitions (self effi- cacy expectancies). It will also be possible to examine whether differences in clinical outcomes and behaviours are due to intervention effect on beliefs and cognitions.
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The effect of a text message and telephone follow-up program on cardiac self-efficacy of patients with coronary artery disease: A randomized controlled trial

The effect of a text message and telephone follow-up program on cardiac self-efficacy of patients with coronary artery disease: A randomized controlled trial

Materials and Methods: This was a randomized controlled trial on 70 patients with CAD who were hospitalized in Shahid Chamran Hospital (Isfahan, Iran). The participants were randomly assigned to the experimental and control groups. Collection of data on cardiac self-efficacy was performed before, 3 months after, and 4 months after the beginning of the intervention using Cardiac Self-Efficacy Scale designed by Sullivan et al. During the 3 months of intervention, six messages were sent to the subjects each week and calls were made twice a week in the first month and once a week during the second and third months. The statistical analysis of data was performed using independent t-test, Chi-square, Mann–Whitney U test, and repeated measures analysis of variance (ANOVA). Results: Before the intervention, there was no significant difference between the mean scores of cardiac self-efficacy of the two groups. However, 3 months and 4 months after the beginning of the intervention, the mean score of cardiac self-efficacy in the experimental group was significantly higher than in the control group (P < 0.001).
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Trace element supplementation in hemodialysis patients: a randomized controlled trial

Trace element supplementation in hemodialysis patients: a randomized controlled trial

safety. In addition to reducing the frequency of low zinc and/or selenium levels, a future study demonstrating ben- efits for patient-important outcomes would be required to inform clinical practice. Third, assessment of zinc and sel- enium status is complex, and potentially affected by nutri- tional status as well as shifts between intracellular and extracellular compartments [20-22]. Although blood levels are considered acceptable measures of zinc and selenium status, the precise level that represents biological defi- ciency is not known for the general population or for dia- lysis patients. We did not evaluate biomarkers of zinc status such as serum metallothionein activity or plasma levels of glutathione peroxidase. Fourth, and most import- ant, the doses of supplementation used were relatively conservative, which may have reduced the likelihood of showing a beneficial effect on trace element status in this population.
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Original Article Continuous positive airway pressure and cardiovascular outcomes in obstructive sleep apnoea patients: a systematic review and meta-analysis of randomized controlled trials

Original Article Continuous positive airway pressure and cardiovascular outcomes in obstructive sleep apnoea patients: a systematic review and meta-analysis of randomized controlled trials

age of overall variability attributable to hetero- geneity, with a value of lower than 50% indicat- ing mild heterogeneity of bias. Egger’s and Begg’s tests were used to identify small-study effects [13, 14]. This study did not visually exa- mine publication bias with funnel plots, as it is indicated for meta-analyses of more than 10 studies [15]. Sensitivity analyses were peform- ed to show how effect sizes changed after the removal of each individual study. All statistical analyses were performed with Stata 14.0 soft- ware (Stata, College Station, Texas, USA). Results

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HHS Public Access Author manuscript Trends Neurosci. Author manuscript; available in PMC 2019 May 01.

HHS Public Access Author manuscript Trends Neurosci. Author manuscript; available in PMC 2019 May 01.

As a salient alternating environmental cue, light acts as one of the most powerful signal that influences our behaviour and health [7]. As such, over the last three decades, exposure to bright light has been used as a therapy to treat several disorders including mood disorders, cognitive disabilities, circadian misalignment, and alterations of sleep/wake behaviour [7]. Building on this experience, bright light therapy (BLT) has been recently introduced to PD with the perspective of improving the quality of life of PD patients. So far only four studies have assessed the efficacy and safety of BLT in PD patients [2–5]. Bright light pulses of intensities and durations ranging from 1.000 to 10.000 lux and 30min to 1.5h respectively were used daily either in the morning (1h after awakening [3]) or in the evening (1h before bedtime [2,4]) or twice daily [5] over varying periods, from one week to several months [2– 5]. Efficacy of BLT was assessed using both routine clinical examination of PD patients over time and several validated instruments and questionnaires that evaluate both motor and NMS in PD patients. Taken together, these studies have demonstrated that BLT significantly improves motor dysfunction including bradykinesia, rigidity, tremor, nocturnal movements, dyskinesia and postural imbalance [2–4]. Improvements in motor functions were also captured with actigraphy, an objective measurement of overall physical activity in the most recent study [5]. Like in other forms of depression [7], bright light had anti-depressant and anti-anxious effects in PD patients. Several alterations of sleep behaviour were improved. These included insomnia, excessive daytime sleepiness and the overall fragmentation of sleep/wake cycle [3–5]. The rate of improvement of these symptoms was variable; both anxiety and insomnia improved quickly within days while motor functions improved slowly over months to years [2–5]. Near-infrared light (NIr; 670nm) therapy has also been tested in the context of PD. Although still in its pre-clinical stage, when applied intracranially just above the midbrain, NIr light reduced clinical signs and offered neuroprotections against MPTP intoxication in a non-human primate model of PD [13]. In summary, these results suggest that light has a substantial therapeutic potential for both motor and NMS of PD. However, the field is still in its infancy and further investigations are needed. For example, in many ways, current understanding of both the mechanisms of light therapy and PD
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Efficacy of a pressure sensing mattress cover system for reducing interface pressure: study protocol for a randomized controlled trial

Efficacy of a pressure sensing mattress cover system for reducing interface pressure: study protocol for a randomized controlled trial

While this RCT in itself is not likely to be sufficient to inform health system decision making on whether to purchase CPI systems en masse, the findings could pro- vide greater understanding of the use of this technology in clinical practice. This study also has the potential to increase our understanding of the relation between interface pressure and skin and tissue changes resulting from the exposure to prolonged pressure. A much larger trial would be required in subsequent stages to deter- mine the impact of CPI on the hard clinical endpoint of overt pressure ulceration, that is, the clinical outcome that we are ultimately trying to prevent. The present RCT described here will build significantly on previous research on interface pressure and pressure ulcer devel- opment, and it will clarify the role of CPI in modifying interface pressures, an important intermediate goal in the prevision pressure ulcers.
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Rationale and design of a randomized controlled trial of the effect of retinol and vitamin D supplementation on treatment in active pulmonary tuberculosis patients with diabetes

Rationale and design of a randomized controlled trial of the effect of retinol and vitamin D supplementation on treatment in active pulmonary tuberculosis patients with diabetes

Despite its strengths, trial limitations should be noted. In our trial, only some doses of VA and VD are observed. However, we designed these doses on the basis of acquir- ing important information including the VA nutrition sta- tus in China by national survey [25], the recommended VA and VD intake formulated by the Chinese nutrition society. Also, abundant literature researches concerning the VA, VD level in the supplementation trials have been implemented. In addition, different distribution of some aspects of the subject in the four arms such as severity of the disease, fundamental nutrition status, socioeconomics status etc. may interfere or reduce our measured effect size. To minimize the differential effect between the four arms, we balanced the four arms regarding age, sex and randomized the subjects to different groups. Furthermore, multivariate logistic regression will be used to identify the measured size to adjust the possible impact factors.
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IHDIP: a controlled randomized trial to assess the security and effectiveness of the incremental hemodialysis in incident patients

IHDIP: a controlled randomized trial to assess the security and effectiveness of the incremental hemodialysis in incident patients

conventional hemodialysis. The objective of the present controlled randomized trial (RCT) is to determine if start HD with one sessions per week (1-Wk/HD), it is associated with better patient survival and other safety parameters. Methods/design: IHDIP is a multicenter RCT experimental open trial. It is randomized in a 1:1 ratio and controlled through usual clinical practice, with a low intervention level and non-commercial. It includes 152 incident patients older than 18 years, with a RRF of ≥ 4 ml/min/1.73 m2, measured by renal clearance of urea (KrU). The intervention group includes 76 patients who will start with incremental HD (1-Wk/HD). The control group includes 76 patients who will start with thrice-weekly hemodialysis régimen. The primary outcome is assessing the survival rate, while the secondary outcomes are the morbidity rate, the clinical parameters, the quality of life and the efficiency. Discussion: This study will enable to know the number of sessions a patient should receive when starting HD, depending on his RRF. The potentially important clinical and financial implications of incremental hemodialysis warrant this RCT.
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