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

INTRODUCTION: Intradialytic 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 a...

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Autores principales: Tsai, Ming-Yen, Su, Yu-Jen, Ng, Hwee-Yeong, Chen, Shih-Yu, Huang, Yu-Chuen, Wu, Chien-Hsing, Chen, Yung-Hsiang
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4800128/
https://www.ncbi.nlm.nih.gov/pubmed/26966058
http://dx.doi.org/10.1136/bmjopen-2015-009976
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author Tsai, Ming-Yen
Su, Yu-Jen
Ng, Hwee-Yeong
Chen, Shih-Yu
Huang, Yu-Chuen
Wu, Chien-Hsing
Chen, Yung-Hsiang
author_facet Tsai, Ming-Yen
Su, Yu-Jen
Ng, Hwee-Yeong
Chen, Shih-Yu
Huang, Yu-Chuen
Wu, Chien-Hsing
Chen, Yung-Hsiang
author_sort Tsai, Ming-Yen
collection PubMed
description INTRODUCTION: Intradialytic 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/ANALYSIS: In 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/DISSEMINATION: This 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 NUMBER: NCT02210377; Pre-results.
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spelling pubmed-48001282016-03-29 Study protocol for a single-blind, placebo-controlled randomised trial of Tianjiu effects in patients with intradialytic hypotension Tsai, Ming-Yen Su, Yu-Jen Ng, Hwee-Yeong Chen, Shih-Yu Huang, Yu-Chuen Wu, Chien-Hsing Chen, Yung-Hsiang BMJ Open Complementary Medicine INTRODUCTION: Intradialytic 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/ANALYSIS: In 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/DISSEMINATION: This 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 NUMBER: NCT02210377; Pre-results. BMJ Publishing Group 2016-03-10 /pmc/articles/PMC4800128/ /pubmed/26966058 http://dx.doi.org/10.1136/bmjopen-2015-009976 Text en Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/ This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
spellingShingle Complementary Medicine
Tsai, Ming-Yen
Su, Yu-Jen
Ng, Hwee-Yeong
Chen, Shih-Yu
Huang, Yu-Chuen
Wu, Chien-Hsing
Chen, Yung-Hsiang
Study protocol for a single-blind, placebo-controlled randomised trial of Tianjiu effects in patients with intradialytic hypotension
title Study protocol for a single-blind, placebo-controlled randomised trial of Tianjiu effects in patients with intradialytic hypotension
title_full Study protocol for a single-blind, placebo-controlled randomised trial of Tianjiu effects in patients with intradialytic hypotension
title_fullStr Study protocol for a single-blind, placebo-controlled randomised trial of Tianjiu effects in patients with intradialytic hypotension
title_full_unstemmed Study protocol for a single-blind, placebo-controlled randomised trial of Tianjiu effects in patients with intradialytic hypotension
title_short Study protocol for a single-blind, placebo-controlled randomised trial of Tianjiu effects in patients with intradialytic hypotension
title_sort study protocol for a single-blind, placebo-controlled randomised trial of tianjiu effects in patients with intradialytic hypotension
topic Complementary Medicine
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4800128/
https://www.ncbi.nlm.nih.gov/pubmed/26966058
http://dx.doi.org/10.1136/bmjopen-2015-009976
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