2026-526167-38-00招募中4 期
ALBUMINUS: Dose reduction of human albumin during large-volume paracentesis in patients with cirrhosis
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 634
- 试验地点
- 17
研究概览
简要总结
The primary objective of this study is to demonstrate that low-dose IV HA (4 g/L) is non-inferior to the standard 8 g/L regimen in preventing future liver-related decompensation events, defined as spontaneous bacterial peritonitis, hepatorenal syndrome - acute kidney injury (HRS-AKI), variceal bleeding, and hepatic encephalopathy, in patients with cirrhosis undergoing LVP.
研究设计
- 分配方式
- Randomized
- 主要目的
- Albuminus
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Portal hypertension-driven ascites due to cirrhosis requiring LVP.
- •Documented informed consent to participate.
排除标准
- •New-onset AKI before screening and randomization, defined as an increase in serum creatinine of ≥ 26.5 μmol/L within 48 hours, or an increase of serum creatinine to ≥ 1.5 times the baseline creatinine level within 7 days.
- •Hemodynamic instability, defined as a mean arterial pressure < 60 mmHg.
- •Systemic infection, defined as documentation or strong clinical suspicion of an infectious source.
- •TIPS procedure in past medical history or planned.
- •Patients with advanced hepatocellular carcinoma (HCC) stage BCLC-B or higher.
- •Variceal bleeding within one week prior to presentation.
- •Acute-on-chronic liver failure (ACLF) defined as a chronic liver failure consortium organ failure score of 8 or higher (representing ≥ 2 (out of 6) failing organ systems), using the CLIF-C organ failure score.
- •Patients who have already been included in the study previously.
研究者
Marten Lantinga
Scientific
Amsterdam UMC Stichting
研究点 (17)
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