Dataset Information

Efficacy and safety of furosemide for prevention of intradialytic hypotension in haemodialysis patients: protocol for a multicentre randomised controlled trial.

ABSTRACT:

Introduction

Intradialytic hypotension (IDH) is a frequent and serious complication of maintaining haemodialysis (HD) patients and associated with subsequent cardiovascular events and higher mortality. Furosemide is commonly used in non-dialysis chronic kidney disease patients and can effectively manage the volume and blood pressure. However, these agents are often discontinued on initiation of dialysis. Two large observational studies have demonstrated that furosemide can lower the rate of IDH episodes. However, there is still no randomised controlled trial (RCT) to investigate the efficacy and safety of furosemide for prevention of IDH in HD patients. The purpose of this study was to assess the efficacy of furosemide in reducing IDH in HD patients with residual renal function.

Methods and analysis

A two-arm, parallel, multicente RCT will be conducted at 12 hospitals in China. An estimated sample of 560 HD patients will be recruited. Eligible patients will be randomly assigned to treatment group (patients receive oral furosemide 80 mg/day; after a 2-week treatment, if their urine volume is less than 400 mL/day, the dose of furosemide is adjusted to 160 mg/day) and blank control group via a central randomisation system using 1:1 ratio. The primary outcome is the occurrence of IDH. Outcome assessors and data analysts will be blinded and participants will be asked not to reveal their allocation to assessors. The outcome analyses will be performed both on the intention-to-treat, which includes all patients randomised, and per-protocol population, which includes eligible patients who adhere to the planned treatment and follow-ups.

Ethics and dissemination

The trial protocol has been approved by the Biomedical Research Ethics Committee of West China Hospital of Sichuan University (2019.385)Results will be presented at national and international conferences and published in peer-reviewed journals.

Trial registration number

ChiCTR2000039724.

SUBMITTER: Chen W

PROVIDER: S-EPMC8258570 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ObjectiveTo assess the efficacy and safety of intradialytic exercise for haemodialysis patients.DesignSystematic review and meta-analysis.Data sourcesDatabases, including PubMed, Embase, the Cochrane Library, China Biology Medicine and China National Knowledge Infrastructure, were screened from inception to March 2017.Eligibility criteriaRandomised controlled trials (RCTs) aimed at comparing the efficacy and safety of intradialytic exercise versus no exercise in adult patients on haemodialysis for at least 3 months. A minimum exercise programme period of 8 weeks.Data extractionStudy characteristics and study quality domains were reviewed. Studies were selected, and data extracted by two reviewers.Data analysisThe pooled risk ratios and mean differences (MDs) with 95% CIs for dichotomous data and continuous data were calculated, respectively.ResultsA total of 27 RCTs involving 1215 subjects were analysed. Compared with no exercise, intradialytic exercise increased dialysis adequacy (Kt/V) (MD 0.07, 95% CI 0.01 to 0.12, p=0.02) and maximum volume of oxygen that the body can use during physical exertion peak oxygen consumption (MD 4.11, 95% CI 2.94 to 5.27, p<0.0001), alleviated depression standardised mean difference (-1.16, 95% CI -1.86 to -0.45, p=0.001) and improved physical component summary-short form-36 (SF-36) level (MD 7.72, 95% CI 1.93 to 13.51, p=0.009). Also, intradialytic exercise could significantly reduce systolic blood pressure (MD -4.87, 95% CI -9.20 to -0.55, p=0.03) as well as diastolic blood pressure (MD -4.11, 95% CI -6.50 to -1.72, p=0.0007). However, intradialytic exercise could not improve mental component summary-SF-36 level (MD 3.05, 95% CI -1.47 to 7.57, p=0.19). There was no difference in the incidence of adverse events between the intradialytic exercise and control groups.ConclusionsIntradialytic exercise resulted in benefits in terms of improving haemodialysis adequacy, exercise capacity, depression and quality of life for haemodialysis.

Project description:BackgroundIntradialytic hypotension (IDH) is a common complication of haemodialysis (HD), and a risk factor of cardiovascular morbidity and death. Several clinical studies suggested that reduction of dialysate temperature, such as fixed reduction of dialysate temperature or isothermal dialysate using a biofeedback system, might improve the IDH rate.ObjectivesThis review aimed to evaluate the benefits and harms of dialysate temperature reduction for IDH among patients with chronic kidney disease requiring HD, compared with standard dialysate temperature.Search methodsWe searched Cochrane Kidney and Transplant's Specialised Register up to 14 May 2019 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal, and ClinicalTrials.gov.Selection criteriaAll randomised controlled trials (RCTs), cross-over RCTs, cluster RCTs and quasi-RCTs were included in the review.Data collection and analysisTwo authors independently extracted information including participants, interventions, outcomes, methods of the study, and risks of bias. We used a random-effects model to perform quantitative synthesis of the evidence. We assessed the risks of bias for each study using the Cochrane 'Risk of bias' tool. We assessed the certainty of evidence using Grades of Recommendation, Assessment, Development and Evaluation (GRADE).Main resultsWe included 25 studies (712 participants). Three studies were parallel RCTs and the others were cross-over RCTs. Nineteen studies compared fixed reduction of dialysate temperature (below 36°C) and standard dialysate temperature (37°C to 37.5°C). Most studies were of unclear or high risk of bias. Compared with standard dialysate, it is uncertain whether fixed reduction of dialysate temperature improves IDH rate (8 studies, 153 participants: rate ratio 0.52, 95% CI 0.34 to 0.80; very low certainty evidence); however, it might increase the discomfort rate compared with standard dialysate (4 studies, 161 participants: rate ratio 8.31, 95% CI 1.86 to 37.12; very low certainty evidence). There were no reported dropouts due to adverse events. No study reported death, acute coronary syndrome or stroke.Three studies compared isothermal dialysate and thermoneutral dialysate. Isothermal dialysate might improve the IDH rate compared with thermoneutral dialysate (2 studies, 133 participants: rate ratio 0.68, 95% CI 0.60 to 0.76; I2 = 0%; very low certainty evidence). There were no reports of discomfort rate (1 study) or dropouts due to adverse events (2 studies). No study reported death, acute coronary syndrome or stroke.Authors' conclusionsReduction of dialysate temperature may prevent IDH, but the conclusion is uncertain. Larger studies that measure important outcomes for HD patients are required to assess the effect of reduction of dialysate temperature. Six ongoing studies may provide much-needed high quality evidence in the future.

Project description:RATIONALE & OBJECTIVE:Intradialytic hypotension (IDH) is a common complication at the initiation of hemodialysis (HD) therapy, is associated with greater mortality, and may be related to relatively rapid shifts in plasma osmolality. This study sought to evaluate the effect of an intervention to minimize intradialytic changes in plasma osmolality on the occurrence of IDH. STUDY DESIGN:Double-blind, single-center, randomized, controlled trial. SETTING & PARTICIPANTS:Individuals requiring initiation of HD for acute or chronic kidney disease. INTERVENTION:Mannitol, 0.25g/kg/h, versus a similar volume of 0.9% saline solution during the first 3 HD sessions. OUTCOMES:The primary end point was average decline in systolic blood pressure (SBP). The secondary end point was the proportion of total sessions complicated by IDH (defined as a decrease ? 20mm Hg from the pre-HD SBP). Exploratory end points included biomarkers of cardiac and kidney injury. RESULTS:52 patients were randomly assigned and contributed to 156 study visits. There were no significant differences in average SBP decline between the mannitol and placebo groups (15±11 vs 19±16mm Hg; P = 0.3). The proportion of total sessions complicated by IDH was lower in the mannitol group compared to placebo (25% vs 43%), with a nominally lower risk for developing an episode of IDH (OR, 0.38; 95% CI, 0.14-1.00), though this finding was of borderline statistical significance (P = 0.05). There were no consistent differences in cardiac and kidney injury biomarker levels between treatment groups. LIMITATIONS:Modest sample size and number of events. CONCLUSIONS:In this pilot randomized controlled trial studying patients requiring initiation of HD, we found no difference in absolute SBP decline between those who received mannitol and those who received saline solution. However, there were fewer overall IDH events and a nominally lower risk for dialysis sessions being complicated by IDH in the mannitol group. A larger multicenter randomized controlled trial is warranted. FUNDING:Government funding to an author (Dr Mc Causland is supported by National Institute of Diabetes and Digestive and Kidney Diseases grant K23DK102511). TRIAL REGISTRATION:Registered at ClinicalTrials.gov with study number NCT01520207.

Project description:IntroductionIntradialytic cycling is often performed during the first half of hemodialysis because of concerns regarding increased frequency of intradialytic hypotension (IDH) late in hemodialysis. This increases exercise program resource needs and limits utility of intradialytic cycling to treat dialysis-related symptoms.MethodsThis multicenter, randomized, crossover trial compared IDH rate when cycling during the first half versus the second half of hemodialysis in 98 adults on maintenance hemodialysis. Group A cycled during the first half of hemodialysis for 2 weeks and subsequently during the second half for 2 weeks. In group B, the cycling schedule was reversed. Blood pressure (BP) was measured every 15 minutes throughout hemodialysis. Primary outcome was IDH rate (systolic BP [SBP] decrease of >20 mm Hg or SBP <90 mm Hg). Secondary outcomes included symptomatic IDH rate and time to recover post hemodialysis. Data were analyzed using negative binomial and gamma distribution mixed regression.ResultsMean age 64.7 (SD 12.0) and 64.7 (SD 14.2) years in group A (n = 52) and group B (n = 46), respectively. Proportions of females were 33% in group A and 43% in group B. Median time on hemodialysis was 4.1 (interquartile range [IQR] 2.5, 6.1]) years in group A and 3.9 years (IQR 2.5, 6.7) in group B. IDH rate per 100 hemodialysis hours (95% confidence interval [CI]) was 34.2 (26.4, 42.0) and 36.0 (28.9, 43.1) during early and late intradialytic cycling, respectively (P = 0.53). Timing of intradialytic cycling was not associated with symptomatic IDH (relative risk [RR]: 1.07 [0.75-1.53]) or time to recover post hemodialysis (odds ratio: 0.99 [0.79-1.23]).ConclusionWe found no association between the rate of overall or symptomatic IDH and the timing of intradialytic cycling in patients enrolled in an intradialytic cycling program. Increased use of cycling late in hemodialysis may optimize intradialytic cycling program resource use and should be studied as a possible treatment for symptoms common in late hemodialysis.