Comparison of the effect of Plasmalyte and Normal saline on intraoperative inotropes and vasopressors requirements in patients undergoing emergency gastrointestinal perforation surgery- A pragmatic randomised controlled trial
概览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- Jipmer intramural grant
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- To determine and compare the effect of plasmalyte and 0.9% saline on intraoperative vasopressors and inotropes requirements undergoing emergency gastrointestinal perforation surgery.
概览
简要总结
This study is a pragmatic, randomised, controlled trial, comparing the effect of plasmalyte and 0.9% saline on intraoperative vasopressor and inotrope requirement undergoing emergency gastrointestinal perforation surgery. It will be conducted in patients coming to JIPMER, Puducherry hospital. The primary outcome measures will be intraoperative vasopressor and inotrope requirement in these two groups. Secondary outcome will be their effect on acid base balance and lactate. Effect on acute kidney injury molecule. Comparing the effect of predefined composite of renal, cardiovascular and respiratory system complications and effect on in hospital mortality, intensive care unit stay and hospital stay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •American Society of Anesthesiologists (ASA) physical status I, II, III and IV 2) Patient undergoing emergency gastrointestinal perforation surgery.
排除标准
- •Patient already receiving mechanical ventilation 2) Patient already receiving inotrope 3) Acute or chronic preexisting kidney disease 4) Uncontrolled diabetes mellitus/patients requiring insulin therapy 5) History of known anaphylactic reaction 6) Hyperkalemia 7) patients with hepatic dysfunction (total bilirubin above 2mg/dl, sgot and sgpt values more than 2 times normal values).
结局指标
主要结局
To determine and compare the effect of plasmalyte and 0.9% saline on intraoperative vasopressors and inotropes requirements undergoing emergency gastrointestinal perforation surgery.
时间窗: At the end of study. (2yrs approx)
次要结局
- To compare the effect on postoperative acid-base status and lactate(At the end of study. (2yrs approx))
- To compare the effect on acute kidney injury marker (kidney injury molecule-1)
- To compare the effect of predefined composite of renal, cardiovascular and respiratory system complications
- To compare the effect on in-hospital mortality, intensive care unit stay and hospital stay(At the end of study. (2yrs approx))
研究者
Dr Niteesh
JIPMER