drugset / Trial / NCT07823530

Bioelectrical Response to Preoperative Hydration in Colorectal Surgery

NCT07823530 ↗

Not yet recruiting 120 enrolled University Hospital of Split
NaSingle-groupOpen-labelBasic science

Summary

This single-center study will evaluate whether short-term changes in bioelectrical impedance measurements after a standardized preoperative intravenous fluid infusion can help predict complications following elective colon or rectal surgery. The prospective group will include 120 consecutive adults. After emptying the bladder, participants will be weighed and assessed barefoot on a standing multifrequency bioelectrical impedance device. They will then receive Ionolyte, a balanced isotonic crystalloid, at 15 mL/kg based on the lower of actual and ideal body weight, up to 1,000 mL, over exactly 40 minutes. Participants will empty the bladder again and undergo repeat measurement 60 minutes after infusion start. The main predictor is the continuous change in phase angle, and the main outcome is at least one Clavien-Dindo grade II-V complication within 30 days. A supportive analysis will compare clinical outcomes with 240 consecutive historical controls using existing hospital records. The historical controls do not receive the study procedure and are not included in the prospective enrollment.

Timeline

Start
2026-10-01
Primary completion
2028-10-30
Completion
2033-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Ionolyte Other / unclassified 15 unknown Intravenous

Indications

No indication recorded.