Effect on Kidney Function Recovery Guiding Decongestion With VExUS in Patients With Cardiorenal Syndrome 1
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Kidney Function Recovery
研究概览
简要总结
During cardiorenal syndrome type 1 (CRS1) vascular congestion is the major contributor to worsening renal function, but promoting decongestion with routine clinical evaluation is ineffective in some patients. The venous evaluation by ultrasound (VExUS) may optimize its management when evaluating for improvement in kidney function and other metrics related to decongestion.
详细描述
Background: In cardiorenal syndrome type 1 (CRS1) vascular congestion is a common complication, the Venus Evaluation by Ultrasound System (VExUS) could guide decongestion effectively and thereby improve kidney function outcomes.
Methods: In this double-blind randomized clinical trial, patients with CRS1 were randomized to guide decongestion with VExUS compared to usual clinical evaluation. The primary and secondary endpoint was to assess kidney function recovery (KFR), days of hospitalization, mortality, changes in brain natriuretic peptide (BNP) and CA-125. Protocol register HCG/CEI-0836/22.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Allocation was performed by the cardiology staff on a concealed opaque envelope until the beginning of the study. A double-blind, double dummy design was used.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cardiorenal Syndrome type 1
排除标准
- •kidney transplantation, chronic kidney disease (CKD) grade 4 or 5, dialysis and pregnancy. CKD was defined according to the KDIGO guidelines
结局指标
主要结局
Kidney Function Recovery
时间窗: from hospitalization to discharge, or date of death from any cause, whichever came first, assessed up to 90 days
Assess Kidney Function Recovery evaluated as serum Creatinine return to baseline value
次要结局
- vascular decongestion during hospitalization(from hospitalization to discharge, or date of death from any cause, whichever came first, assessed up to 90 days)
研究者
Jonathan Samuel Chavez Iñiguez
Dr.
Hospital Civil de Guadalajara