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Clinical Trials/CTRI/2025/10/096269
CTRI/2025/10/096269
Not yet recruiting
Not Applicable

Development of a Novel Fluid Tolerance index in patients undergoing Emergency Laparotomy

AIIMS, New Delhi1 site in 1 country165 target enrollmentStarted: October 28, 2025Last updated:

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

Sponsor
AIIMS, New Delhi
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Kritikha R

AIIMS New Delhi

Study Sites (1)

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