Bioelectrical Response to Preoperative Hydration in Colorectal Surgery

NCT07823530 | Not Yet Recruiting

• 3 other identifiers: BIA-HYDRATE-CRC2181-147/01-06/LJ.Z.-26-022181-147/01-06/LJ.Z.-26-04
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Complications

Keywords

Colorectal Surgery; Bioelectrical Impedance Analysis; Phase Angle; Extracellular Water; Intracellular Water; Body Composition; Preoperative Hydration; Balanced Isotonic Crystalloid; Perioperative Fluid Therapy; Clavien-Dindo Classification

Outcome Measures

Primary Outcomes (1)

• Participants With at Least One Clavien-Dindo Grade II-V Postoperative Complication

  Number and proportion of participants experiencing at least one postoperative complication graded II, III, IV, or V according to the Clavien-Dindo classification.

  From surgery through postoperative day 30

Secondary Outcomes (19)

• Change in Phase Angle

  T0 to 60 minutes after infusion start

• Change in Extracellular Water

  T0 to 60 minutes after infusion start

• Major Postoperative Complications

  Through postoperative day 30

• Comprehensive Complication Index

  Through postoperative day 30

• Surgical-Site Infection

  Through postoperative day 30

Study Arms (1)

Standardized Ionolyte Hydration and Serial BIA

EXPERIMENTAL

Prospective participants undergo standardized BIA and weighing at T0 after bladder emptying, protocol-defined Ionolyte infusion over exactly 40 minutes, repeat bladder emptying, and BIA and weighing at T60, followed by usual elective colon or rectal resection and outcome follow-up.

Drug: Ionolyte Balanced Isotonic Crystalloid

Interventions

Ionolyte Balanced Isotonic Crystalloid DRUG

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.

Also known as: Balanced Isotonic Crystalloid

Standardized Ionolyte Hydration and Serial BIA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Scheduled for elective colon or rectal resection at University Hospital of Split
• Written informed consent before research-specific procedures
• Able to stand safely and complete both BIA measurements
• Preoperative eGFR at least 60 mL/min/1.73 m²
• Clinically eligible for the protocol fluid volume

You may not qualify if:

• Emergency surgery
• eGFR below 60 mL/min/1.73 m² or oliguria
• Heart failure or clinically significant cardiac disease making fluid loading inappropriate
• Edema, pulmonary congestion, or clinically significant ascites
• Active implantable electrical device
• Limb amputation, inability to undergo standardized standing BIA, or unsafe standing
• Clinically significant electrolyte abnormality
• Pregnancy
• Contraindication to Ionolyte or any clinician safety concern
• Inability to provide valid informed consent

Sponsors & Collaborators

• University Hospital of Split: lead

Study Sites (1)

University Hospital of Split, Department of Surgery

Split, Split-Dalmatia County, 21000, Croatia

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Petra Nizeteo, MD

  University Hospital of Split

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ognjen Barcot, MD, PhD

CONTACT

+38521556691; ognjen.barcot@kbsplit.hr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: All participants receive the same standardized preoperative Ionolyte infusion and undergo BIA measurements at T0 and T60; there is no concurrent control arm.

Study Record Dates

• First Submitted: September 8, 2026
• First Posted: September 16, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 30, 2028
• Study Completion (Estimated): September 30, 2033
• Last Updated: September 16, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)