Restrictive vs Liberal fluid management in sepsis induced hypotension
Overview
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Pt JNM Medical College Raipur CG
- Enrollment
- 364
- Locations
- 1
- Primary Endpoint
- Death from any cause before discharge home or by day 90
Overview
Brief Summary
This is a prospective randomized study to compare restrictive vs liberal fluid management in patient undergoing sepsis induce hypotension.A total number of 364 patient were enrolled in the study presenting to the CCU and will be randomized onto two two groups through sealed envelope techniques .Group A with 182 patient receiving vasopressor as noradrenaline 5 ampoule till MAP is maintained greater than 65 mmHg Patient will be reassessed after one hour and if MAP is not maintain second vasopressor as Vasopressin at the rate 2.4 ml/hour will be started and will be assessed till one hour. In Group B with 182 patient will receive 2 liters of bolus fluid over 1 hour followed by 2 liters over next 4 hour to maintain MAP >65 mmHg Primary outcome will be measured as Death from any cause brfore discharge or by day 90 and secndary outcomes measured will be in terms of days free from ventilator use,days free from renal replacement therapy,days free from vasopressor use, days out of CCU.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Adult patient from 18-65 years of age with sepsis induced hypotension confirmed through SIRS diagnostic criteria with MAP less than 65 mmHg.
Exclusion Criteria
- •Previous reception of greater 3000ml of IV fluid Elapse of greater than 6 hour on admission to hospital End stage renal failure Elevated jugular venous pressure Gastrointestinal bleeding in absence of fever congestive heart failure.
Outcomes
Primary Outcomes
Death from any cause before discharge home or by day 90
Time Frame: 90 days
Secondary Outcomes
- Days free from ventilator use(90 days)
- day free from renal replacement therapy(Day 90)
- Days free from vasopressor use(Day 90)
- Day out of CCU(By day 90)
Investigators
Dr Anamika Tiwari
Pt. JNM medical college ,Dr. BRAM hospital raipur