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NOT YET RECRUITING
NCT07823530
NA

Bioelectrical Response to Preoperative Hydration in Colorectal Surgery

Sponsor: University Hospital of Split

View on ClinicalTrials.gov

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.

Official title: Bioelectrical Response to Standardized Preoperative Hydration and Its Association With Short- and Long-Term Outcomes After Elective Colon and Rectal Resections: An Ambispective Controlled Cohort Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-10-01

Completion Date

2033-09-30

Last Updated

2026-09-16

Healthy Volunteers

No

Interventions

DRUG

Ionolyte Balanced Isotonic Crystalloid

Ionolyte is administered intravenously at 15 mL/kg dosing weight, up to a maximum of 1,000 mL, over exactly 40 minutes. Dosing weight is the lower of actual body weight measured at T0 and ideal body weight calculated from sex and height using the Robinson equations. The infusion rate in mL/h equals the total volume multiplied by 1.5.

Locations (1)

University Hospital of Split, Department of Surgery

Split, Split-Dalmatia County, Croatia