Study protocol for a single-blind, placebo-controlled randomised trial of Tianjiu effects in patients with intradialytic hypotension

Abstract

IntroductionIntradialytic hypotension (IDH) is the most frequent complication of haemodialysis (HD) and may contribute to cardiovascular events and high mortality. The aetiology of IDH is multifactorial; therefore, it remains a challenging problem in the management of patients with HD. Since the application of Tianjiu at specific points can influence haemodynamics, we hypothesise that Tianjiu therapy at the traditionally used meridian points will reduce the severity of hypotension in patients who undergo HD.Methods/analysisIn this clinical trial, eligible patients with IDH will be divided randomly and equally into a Tianjiu group and a control group for 4 weeks. In the Tianjiu group, the patients will have Tianjiu applied at three points (conception vessel 4, and bilateral kidney 1) during each HD session. In the control group, patients will have clay patches applied in the same way as those in the Tianjiu treatment group. Both groups will be followed up for 2 weeks. The primary outcome measure will be the percentage of target ultrafiltration achieved, defined as the actual ultrafiltration volume divided by the target ultrafiltration volume. Secondary outcome measures, including frequency of IDH episodes and number of nursing interventions during HD sessions, predialysis and postdialysis blood pressure (BP), patient's participative assessment of the degree of fatigue after dialysis (scale from 0, not at all, to 10, extremely), and recovery time from fatigue after dialysis will be recorded at the 0th and 4th weeks.Ethics/disseminationThis trial has undergone ethical scrutiny and been approved by the ethics review board of Chang Gung Memorial Hospital (Permission number: 102-4749A3 and 104-3156C). The pre-results of this trial will help to determine whether Tianjiu is an effective and safe treatment for IDH, and, if so, whether it is a therapeutic effect rather than a placebo effect.Trial registration numberNCT02210377; Pre-results.

Effects of sertraline in the prevention of low blood pressure in patients undergoing hemodialysis

“…In the present study, there was a relatively high prevalence of patients with IDH (32%) compared to the findings of several studies, in which the prevalence was approximately 20% 2,10,13,15,16,18,20,32 . The high prevalence of IDH may be due to their selection during the summer in the southern hemisphere (January through March 2017), a season in which the patients ingest larger amounts of liquids, leading to an increase of the dry weight and IDWG, thus contributing to an eventual higher need for UF during the HD process.…”

“…It is known that an UF of 10-13 mL/kg/h is not associated with increased mortality for most patients, except for those with heart failure 37 . Therefore, elevated IDWG generates higher UF rates, with a higher probability of IDH 14,15 . Furthermore, the mean age of the patients was 61 years and studies have shown a greater probability of IDH (up to 50%) among the elderly population 10,32 .…”

“…The Open Epi software was used to calculate the sample size. For the statistical calculation, we used a 50% prevalence of exposed and 5% of unexposed treated subjects, with an 80% study power, sample size ratio of 1:1, which resulted in a total of 30 subjects, based on the worldwide prevalence of nephropathy, as well as hemodialysis patients with IDH 2,15,1618,20,32,34 .…”

“…Pathophysiology of IDH is complex and multifactorial 15 , involving different systems and measures, such as osmolarity drop, dialysate temperature, membrane biocompatibility, the use of acetate as buffer, and endotoxin entry into the circulation 10,16,17 .…”

“…Usually when there is a low UF rate, blood pressure (BP) is maintained during HD through capillary refill, peripheral vascular resistance and cardiac output 15,18,19 Other factors like plasma osmolarity, autonomic dysfunction, and increased vasodilator synthesis are also related to this hemodynamic instability. 15 These events may lead to reduction of intravascular volume, increased release of vasodilatory substances, and reduction in vasoconstrictors, as well as complement activation and cytokine release. In turn, these mechanisms lead to reduction of cardiac output and peripheral vascular resistance, with consequent reduction of arterial pressure 16 .…”