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临床试验/CTRI/2024/01/061803
CTRI/2024/01/061803尚未招募不适用

Impact of targeted blood pressure management versus standard care amongst patients undergoing major abdominal surgeries

Amrita institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年1月29日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
200
试验地点
1
主要终点
Any organ dysfunction 24 hours postoperatively

研究概览

简要总结

We aim to evaluate the impact of a targeted blood pressure management within 20 % of baseline value amongst high risk patients undergoing major abdominal surgery. The impact is to be assessed by looking for evidences of any organ dysfunction, cardiac, renal, respiratory, coagulopathy or neurological outcomes.

This may provide us insights on the benefits ofa targeted blood pressure management amongst high risk patients undergoig abdominal surgery

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
45.00 Year(s) 至 72.00 Year(s)(—)
性别
All

入选标准

  • ASA II and above patients above 45 years with one of the following
  • Coronary artery disease
  • cerebrovascular accident
  • peripheral vascular disease undergoing major abdominal surgery lasting more than 4 hours.

排除标准

  • 1.emergency surgery 2.Preoperative ventilation or COPD 3.Renal dysfunction creatinine more than 1.5 4.CAD EF less than 35% 5.AST ALT more than twice normal.

结局指标

主要结局

Any organ dysfunction 24 hours postoperatively

时间窗: 24 hours postoperatively in the ICU

1 Renal as per RIFLE criteria

时间窗: 24 hours postoperatively in the ICU

2 Elevated hsTropT

时间窗: 24 hours postoperatively in the ICU

3 Respiratory SpO2 less than 94 or need for respiratory assist devices

时间窗: 24 hours postoperatively in the ICU

4 Neurological GCS less than 14

时间窗: 24 hours postoperatively in the ICU

5 Coagulation Platelet INR as per SOFA

时间窗: 24 hours postoperatively in the ICU

次要结局

  • Length of ICU stay(Length of hospital stay)

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

DrLakshmi Kumar

Amrita Institute of Medical Sciences

研究点 (1)

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