Development of a Novel Fluid Tolerance index in patients undergoing Emergency Laparotomy
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- AIIMS, New Delhi
- Enrollment
- 165
- Locations
- 1
- Primary Endpoint
- Development of a composite index of cumulative fluid balance, estimated colloidal oncotic pressure, and markers of inflammation/endothelial damage to predict the major post operative complication( Clavein Dindo Grade IV-V)
Overview
Brief Summary
Fluid therapy is the cornerstone of patient management in the perioperative setting. While a liberal approach to fluid therapy was used in the past to prevent hypovolemia and improve organ perfusion , it was shown that tissue inflammation and consequent extravascular leak led to fluid accumulation in the third space, contributing to perioperative complications . As evidence emerged that a positive fluid balance was associated with increased risk of adverse surgical outcomes as well as organ dysfunction, such as acute lung injury , acute kidney injury and prolonged duration of mechanical ventilation and ICU stay, restricted or goal-directed fluid therapy (zero-balance approach) began to replace the conventional approach to fluid management. Whenever intravenous fluid therapy is administered for any reason, only a portion of the total fluid received stays inside the intravascular compartment; the rest extravasates into the capillary interstitial space Capillary fluid leak is determined by net filtration pressure and integrity of capillary endothelium and glycocalyx, the latter one cannot be quantified It arises the need of development of a composite index comprising of colloidal oncotic pressure and markers of inflammation which will module the effect of cumulative fluid balance in post-surgical patients
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 75.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Undergoing emergency abdominal Surgery 2)Duration of surgery at least 2 hours.
Exclusion Criteria
- •Refusal to participate 2) CKD Stage IV or V 3) Pregnancy 4) Moribund patients with expected survival less than 48 hours.
Outcomes
Primary Outcomes
Development of a composite index of cumulative fluid balance, estimated colloidal oncotic pressure, and markers of inflammation/endothelial damage to predict the major post operative complication( Clavein Dindo Grade IV-V)
Time Frame: 72 hours
Secondary Outcomes
- Association between Fluid tolerance index and hospital mortality(72 hours)
- Association of fluid tolerance index and hospital stay(72 hours)
- Association between individual components and post operative clinical outcome(72 hours)
Investigators
Kritikha R
AIIMS New Delhi