Early continuous ultrafiltration in Chinese patients with congestive heart failure (EUC-CHF): study protocol for an
Ying Yang1, Chao Shen2, Jiangting Lu2
1Department of Cardiology, Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, Zhejiang, Hangzhou, China. yylong@zju.edu.cn.
Insights
Early ultrafiltration (UF) may offer an effective alternative to intravenous loop diuretics for managing fluid overload in acute heart failure (HF). This study investigates UF
Area of Science:
- Cardiology
- Nephrology
- Critical Care Medicine
Background:
- Conventional treatments for fluid overload in advanced heart failure (HF), such as intravenous loop diuretics (LDs), have limitations including unpredictable fluid and electrolyte removal.
- Evidence for the efficacy of early ultrafiltration (UF) in relieving edema is limited, leading to its current recommendation as a second-line therapy for refractory congestion.
Purpose of the Study:
- To evaluate the efficacy and safety of early continuous ultrafiltration (UF) compared to intravenous loop diuretics (LDs) in patients with acute decompensated heart failure (ADHF).
- To determine if early UF improves clinical outcomes, reduces volume overload, and prevents rehospitalization in ADHF patients.
- To develop a Chinese population-based scoring system to guide early UF treatment in appropriate ADHF patients.
Main Methods:
- The study is an open-label, registry-based, prospective trial (EUC-CHF) involving patients hospitalized for severe acute decompensated HF with overt fluid overload within 24 hours of admission.
- Forty patients will be randomized into two groups (20 per group) for treatment.
- Primary outcomes include changes in weight loss, dyspnea severity score, and the incidence of major bleeding.
Main Results:
- Data on main results are not yet available as the study is ongoing or recently initiated.
Conclusions:
- The EUC-CHF trial aims to provide crucial evidence on the effectiveness and safety of early UF in managing fluid overload in acute decompensated heart failure.
- Findings are expected to inform clinical practice guidelines and potentially establish early UF as a first-line therapy for specific patient populations.
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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