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
Overview
- Phase
- Phase 3 4
- Status
- Not yet recruiting
- Sponsor
- Jipmer intramural grant
- Enrollment
- 126
- Locations
- 1
- Primary Endpoint
- To determine and compare the effect of plasmalyte and 0.9% saline on intraoperative vasopressors and inotropes requirements undergoing emergency gastrointestinal perforation surgery.
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •American Society of Anesthesiologists (ASA) physical status I, II, III and IV 2) Patient undergoing emergency gastrointestinal perforation surgery.
Exclusion Criteria
- •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).
Outcomes
Primary Outcomes
To determine and compare the effect of plasmalyte and 0.9% saline on intraoperative vasopressors and inotropes requirements undergoing emergency gastrointestinal perforation surgery.
Time Frame: At the end of study. (2yrs approx)
Secondary Outcomes
- 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))
Investigators
Dr Niteesh
JIPMER