Early continuous ultrafiltration in Chinese patients with congestive heart failure (EUC-CHF): study protocol for an open-label registry-based prospective clinical trial

Abstract Background Conventional pharmacologic therapies aim to reduce fluid overload in advanced heart failure (HF) represented by intravenous (IV) loop diuretics (LDs) have sometimes not so efficacious and been reported to have side effects such as unpredictable removal of water and sodium and ele...

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Main Authors: Ying Yang, Chao Shen, Jiangting Lu, Fen Xu, Jinshan Tong, Jiangfen Jiang, Guosheng Fu
Format: Article
Language:English
Published: BMC 2019-11-01
Series:BMC Cardiovascular Disorders
Subjects:
Online Access:http://link.springer.com/article/10.1186/s12872-019-1208-y
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author Ying Yang
Chao Shen
Jiangting Lu
Fen Xu
Jinshan Tong
Jiangfen Jiang
Guosheng Fu
author_facet Ying Yang
Chao Shen
Jiangting Lu
Fen Xu
Jinshan Tong
Jiangfen Jiang
Guosheng Fu
author_sort Ying Yang
collection DOAJ
description Abstract Background Conventional pharmacologic therapies aim to reduce fluid overload in advanced heart failure (HF) represented by intravenous (IV) loop diuretics (LDs) have sometimes not so efficacious and been reported to have side effects such as unpredictable removal of water and sodium and electrolyte disturbance. It is not certain whether early ultrafiltration (UF) is effective than LDs in relieving edema. Given the weakness of evidence for early UF in patients with fluid overload, recommendations of UF in guidelines is considered as second-line therapy only for patients with refractory congestion, who failed to respond to LD-based strategies. Methods The early continuous ultrafiltration in Chinese patients with congestive heart failure (EUC-CHF) trial is an open-label, registry-based, prospective study, recruiting patients with severe acute decompensated HF who are hospitalized for HF worsening due to overt fluid overload 24 h from hospital admission. Forty patients will be enrolled to two treatment groups (n = 20 for each group). The primary outcomes are the changes of weight loss and dyspnea severity score after treatment, as well as the occurrence of clinically overt major bleeding. Discussion EUC-CHF trial was primarily designed to evaluate the efficacy and safety of early UF in patients with acute decompensated HF to reduce volume overload and improve clinical outcome. The trial aims to determine if early UF in acute HF is superior to IV LDs in clinical parameter improvement without adverse events and prevents rehospitalization up to 30 days. Also the trial is expected to establish a scoring system based on Chinese population to guide early UF treatment in appropriate patients. EUC-CHF is one of the first controlled trials tailored to determine the benefit of UF with 24 h from hospital admission. Trial registration www.chictr.org.cn, ChiCTR1800019556. Registered on 18 November 2018.
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spelling doaj.art-83b534a99fb24f489c19ebe8438383022022-12-22T01:19:02ZengBMCBMC Cardiovascular Disorders1471-22612019-11-011911910.1186/s12872-019-1208-yEarly continuous ultrafiltration in Chinese patients with congestive heart failure (EUC-CHF): study protocol for an open-label registry-based prospective clinical trialYing Yang0Chao Shen1Jiangting Lu2Fen Xu3Jinshan Tong4Jiangfen Jiang5Guosheng Fu6Department of Cardiology, Sir Run Run Shaw Hospital, College of Medicine, Zhejiang UniversityDepartment of Cardiology, Sir Run Run Shaw Hospital, College of Medicine, Zhejiang UniversityDepartment of Cardiology, Sir Run Run Shaw Hospital, College of Medicine, Zhejiang UniversityDepartment of Cardiology, Sir Run Run Shaw Hospital, College of Medicine, Zhejiang UniversityDepartment of Cardiology, Sir Run Run Shaw Hospital, College of Medicine, Zhejiang UniversityDepartment of Cardiology, Sir Run Run Shaw Hospital, College of Medicine, Zhejiang UniversityDepartment of Cardiology, Sir Run Run Shaw Hospital, College of Medicine, Zhejiang UniversityAbstract Background Conventional pharmacologic therapies aim to reduce fluid overload in advanced heart failure (HF) represented by intravenous (IV) loop diuretics (LDs) have sometimes not so efficacious and been reported to have side effects such as unpredictable removal of water and sodium and electrolyte disturbance. It is not certain whether early ultrafiltration (UF) is effective than LDs in relieving edema. Given the weakness of evidence for early UF in patients with fluid overload, recommendations of UF in guidelines is considered as second-line therapy only for patients with refractory congestion, who failed to respond to LD-based strategies. Methods The early continuous ultrafiltration in Chinese patients with congestive heart failure (EUC-CHF) trial is an open-label, registry-based, prospective study, recruiting patients with severe acute decompensated HF who are hospitalized for HF worsening due to overt fluid overload 24 h from hospital admission. Forty patients will be enrolled to two treatment groups (n = 20 for each group). The primary outcomes are the changes of weight loss and dyspnea severity score after treatment, as well as the occurrence of clinically overt major bleeding. Discussion EUC-CHF trial was primarily designed to evaluate the efficacy and safety of early UF in patients with acute decompensated HF to reduce volume overload and improve clinical outcome. The trial aims to determine if early UF in acute HF is superior to IV LDs in clinical parameter improvement without adverse events and prevents rehospitalization up to 30 days. Also the trial is expected to establish a scoring system based on Chinese population to guide early UF treatment in appropriate patients. EUC-CHF is one of the first controlled trials tailored to determine the benefit of UF with 24 h from hospital admission. Trial registration www.chictr.org.cn, ChiCTR1800019556. Registered on 18 November 2018.http://link.springer.com/article/10.1186/s12872-019-1208-yEarly ultrafiltrationHeart failureFluid overloadLoop diureticsContinuous renal replacement therapyInflammatory cytokines
spellingShingle Ying Yang
Chao Shen
Jiangting Lu
Fen Xu
Jinshan Tong
Jiangfen Jiang
Guosheng Fu
Early continuous ultrafiltration in Chinese patients with congestive heart failure (EUC-CHF): study protocol for an open-label registry-based prospective clinical trial
BMC Cardiovascular Disorders
Early ultrafiltration
Heart failure
Fluid overload
Loop diuretics
Continuous renal replacement therapy
Inflammatory cytokines
title Early continuous ultrafiltration in Chinese patients with congestive heart failure (EUC-CHF): study protocol for an open-label registry-based prospective clinical trial
title_full Early continuous ultrafiltration in Chinese patients with congestive heart failure (EUC-CHF): study protocol for an open-label registry-based prospective clinical trial
title_fullStr Early continuous ultrafiltration in Chinese patients with congestive heart failure (EUC-CHF): study protocol for an open-label registry-based prospective clinical trial
title_full_unstemmed Early continuous ultrafiltration in Chinese patients with congestive heart failure (EUC-CHF): study protocol for an open-label registry-based prospective clinical trial
title_short Early continuous ultrafiltration in Chinese patients with congestive heart failure (EUC-CHF): study protocol for an open-label registry-based prospective clinical trial
title_sort early continuous ultrafiltration in chinese patients with congestive heart failure euc chf study protocol for an open label registry based prospective clinical trial
topic Early ultrafiltration
Heart failure
Fluid overload
Loop diuretics
Continuous renal replacement therapy
Inflammatory cytokines
url http://link.springer.com/article/10.1186/s12872-019-1208-y
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