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In patients who undergo abdominal surgeries in emergency, does the ratio of fluid balance to oncotic pressure in blood vessels correlate with surgical outcomes?

Not yet recruiting
Conditions
Medical and Surgical,
Registration Number
CTRI/2024/03/063491
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. Adverse effects of intravenous fluid therapy often relate to this extravasation of intravascular fluid, as it causes tissue edema and decreased tissue oxygen delivery leading to poor clinical outcome. One of the four major Starling forces, the plasma colloid oncotic pressure determines the intravascular stay of fluid. Inflammation causes endothelial damage leading to leaky capillaries that exude fluid and protein, reducing the oncotic pressure. Albumin being a negative acute phase reactant is reduced in the perioperative setting and contributes to a lowered value of colloid oncotic pressure.

We postulate that this decreased plasma oncotic pressure might contribute to enhanced extravascular leak that leads to poorer outcomes. While a number of studies have shown adverse clinical outcomes associated with a positive fluid balance intra- and post-operatively, the effect of a reduced colloid oncotic pressure has not been studied in the perioperative period for non-cardiac surgeries.  Furthermore, no study has attempted to see if the ratio of positive cumulative fluid balance to colloid oncotic pressure can be a useful predictor for post-operative complications.

Study hypothesis: Higher cumulative fluid balance to estimated colloid oncotic pressure ratio will be associated with poorer outcomes in patients undergoing emergency abdominal surgery

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
All
Target Recruitment
200
Inclusion Criteria

Adult patients (aged 18-75 years) Either sex Undergoing emergency abdominal surgery Duration of surgery at least 2 hours.

Exclusion Criteria

Refusal to participate CKD stage IV or V AKI stage III or more at the time of admission Pregnancy Moribund patients with expected survival <48 hours.

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Association between cumulative fluid balance to estimated colloid oncotic pressure ratio at 48 hours and any grade of Clavien-Dindo complication after emergency abdominal surgery30 days postoperatively
Secondary Outcome Measures
NameTimeMethod
Association between cumulative fluid balance/estimated colloid oncotic pressure ratio at 48 hours and postoperative AKI within postoperative day 77 days postoperatively
Association between cumulative fluid balance/estimated colloid oncotic pressure ratio at 48 hours and hospital free days at day 3030 days postoperatively
Association between perioperative fluid balance to estimated colloid oncotic pressure ratio (hospital admission to end of surgery) and postoperative complications30 days postoperatively
Association between cumulative fluid balance/estimated colloid oncotic pressure ratio at 48 hours and 30-day mortality30 days postoperatively
Association between cumulative fluid balance to estimated colloid oncotic pressure ratio at 48 hours and Clavien-Dindo grade IVa/b and V complication30 days postoperatively

Trial Locations

Locations (1)

All India Institute of Medical Sciences, New Delhi

🇮🇳

Delhi, DELHI, India

All India Institute of Medical Sciences, New Delhi
🇮🇳Delhi, DELHI, India
Dr Arushi
Principal investigator
9205678052
mailtoarushi511@gmail.com

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