跳至主要内容
临床试验/NCT02414906
NCT02414906已完成2 期

Goal Directed Therapy in the Early Phase of Acute Kidney Injury in Critical Ill Patients

Barretos Cancer Hospital0 个研究点目标入组 99 人开始时间: 2010年6月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
99
主要终点
acute kidney injury

研究概览

简要总结

Acute kidney injury (AKI) is a frequent complication in critically ill patients admitted to intensive care unit (ICU) and it is associated with increased morbimortality.

There is evidence that perioperative hemodynamic optimization decreases the incidence of AKI in the post operative phase in high-risk patients. We aimed to evaluate if the use of a goal-directed therapy to increase oxygen delivery in the early phase of acute kidney injury can decrease the prevalence of patients with acute renal failure.

详细描述

Randomized, controlled, multicenter study.The intervention group was monitored with Flo Trac/Vigileo and optimized with fluid challenges, dobutamine and blood transfusion, if necessary, to maintain a IDO² ≥600ml/min/m² during 8h. The control group was treated according to the discretion of the attending physician.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients admitted in the Intensive Care Unit with Acute Kidney Injury (AKI) classified as AKIN 1 (increase in serum creatinine ≥0.3 mg/dL and/or urine output less than 0.5 ml/kg/h over 6 hours) for less than 12 hours.

排除标准

  • ICU length of stay >10 days, nefrectomy, chronic kidney disease undergoing hemodialysis, baseline creatinine ≥4 mg/dL, life expectance ≤ than 1 month, pregnancy, severe arrhythmia, severe heart failure (≤ III, NYHA), acute myocardial infarction (AMI)

结局指标

主要结局

acute kidney injury

时间窗: 2 months

次要结局

  • death(2 months)

研究者

发起方
Barretos Cancer Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Cristina Prata Amendola

MD

Barretos Cancer Hospital

相似试验