NEPH-ROSIS (NEPHrology in CirRhOSIS) Pilot Trial: A Trial to Treat Acute Kidney Injury Among Hospitalized Cirrhosis Patients
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Differences in mean arterial pressure.
研究概览
简要总结
The goal of this pilot, randomized, single-blind clinical trial is to estimate the effect size of a high and low mean arterial pressure (MAP)-target algorithm among cirrhosis patients hospitalized with acute kidney injury. The main aims to answer are: • Does an algorithm that has low (<80 mmHg) and high (≥80) MAP-targets lead to significant differences in mean arterial pressure? • Are there any serious adverse events (e.g., ischemia) in a high blood pressure algorithm as compared to a low blood pressure algorithm? • Are there any differences in the incidence of AKI reversal in the high v. low MAP-target groups? Participants will be: 1) Randomized to a clinical algorithm that will either target a low (<80 mmHg) or high (≥80 mmHg) MAP. 2) Depending on their group, investigators will titrate commonly used medications to a specific MAP target. Researchers will compare the high and low MAP-target groups to see if these algorithms lead to significant changes in MAP, if they have any impact on AKI reversal, and if there are any adverse events in the high MAP-target group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
This is single blind. The participants will be blinded to their intervention arm. The treating providers will not be blinded as they will receive either the low or high MAP-target treatment algorithm.
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
- •Hospitalized patients with decompensated cirrhosis, defined as a Child-Pugh Score ≥ 7
- •Acute Kidney Injury: a ≥50% increase in sCr from an outpatient baseline sCr measured 7 to 365 days prior to admission
排除标准
- •Patients without a baseline (7 - 365 days prior to AKI development) sCr measurement;
- •Patients who are already on kidney replacement therapy (KRT) at the time of enrollment;
- •Patients with an oxygen requirement greater than 6L via nasal cannula;
- •Patients with a serum creatinine level exceeding 5 mg/dL.
研究组 & 干预措施
Low MAP-Target
This group will be randomized to a treatment algorithm that utilizes a low MAP-target (<80 mmHg) to determine if titration of vasoconstrictors is needed.
干预措施: MAP-Target Algorithm (Drug)
High MAP-Target
This group will be randomized to a treatment algorithm that utilizes a high MAP-target (≥80 mmHg) to determine if titration of vasoconstrictors is needed.
干预措施: MAP-Target Algorithm (Drug)
结局指标
主要结局
Differences in mean arterial pressure.
时间窗: 14 days.
The investigators will determine if a high, as compared to a low, MAP-target algorithm leads to significantly different changes in MAP. This will be completed by comparing the change in MAP from the baseline to the completion of the study.
次要结局
- Acute kidney injury reversal.(14 days)