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NCT Number: NCT07823530

Bioelectrical Response to Preoperative Hydration in Colorectal Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Split, Department of Surgery

Split, Split-Dalmatia County, 21000, Croatia

Location contact

Petra Nizeteo, MD

CONTACT

[email protected]

+38521551457

About this study

The prospective component is protocol-assigned, non-randomized, open-label, and single-group. 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. An eGFR of at least 60 mL/min/1.73 m² is an eligibility criterion and is not used to calculate fluid volume.

From infusion start through T60, food, drink, and other intravenous fluids are withheld unless clinically required. Routine walking to the toilet and standing scale is permitted. Only T0 and T60 research BIA measurements are performed. Clinical care takes priority over the protocol, and symptoms or clinician concern require stopping the infusion and performing a medical assessment.

Short-term outcomes are assessed through 90 postoperative days. Long-term outcomes include overall survival and, in participants with malignant disease, recurrence-free survival for up to five years.

The complete ambispective research program also includes 240 consecutive eligible patients operated on immediately before implementation of the prospective protocol. Their data are obtained retrospectively from existing University Hospital of Split records without contact or additional procedures, under the approved waiver of consent. This historical comparison is not a prospectively assigned ClinicalTrials.gov arm and is not included in the anticipated enrollment of 120.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: Balanced Isotonic Crystalloid

Primary outcomes

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

    Time frame: From surgery through postoperative day 30

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

Secondary outcomes

  1. Change in Phase Angle

    Time frame: T0 to 60 minutes after infusion start

    Whole-body/software-reported phase angle at T60 minus T0, analyzed continuously.

  2. Change in Extracellular Water

    Time frame: T0 to 60 minutes after infusion start

    Extracellular water at T60 minus extracellular water at T0, measured in kilograms and analyzed continuously.

  3. Major Postoperative Complications

    Time frame: Through postoperative day 30

    Participants with at least one Clavien-Dindo grade III-V complication.

  4. Comprehensive Complication Index

    Time frame: Through postoperative day 30

    Cumulative postoperative morbidity on the 0-100 CCI scale; higher scores indicate greater morbidity.

  5. Surgical-Site Infection

    Time frame: Through postoperative day 30

    Participants meeting the protocol-defined surgical-site infection criteria.

  6. Anastomotic Leakage

    Time frame: Through postoperative day 30

    Participants with clinically and/or radiologically diagnosed anastomotic leakage according to the protocol definition.

  7. Number of Participants With Acute Kidney Injury

    Time frame: From surgery through postoperative day 30

    Participants meeting KDIGO acute kidney injury criteria based on available creatinine and/or valid routine urine-output data.

  8. Length of Hospital Stay

    Time frame: From colon or rectal resection through discharge from the hospitalization during which the resection was performed, up to 90 days after surgery

    Number of days from the colon or rectal resection to discharge from the hospitalization during which the resection was performed.

  9. Number of Participants With an Unplanned Reoperation

    Time frame: Through postoperative day 30

    Participants undergoing an unplanned reoperation.

  10. Number of Participants With Hospital Readmission

    Time frame: Through postoperative day 30

    Participants readmitted after discharge.

  11. All-Cause Mortality

    Time frame: Postoperative days 30 and 90

    All-cause mortality reported separately at 30 and 90 days.

  12. Overall Survival

    Time frame: Up to 5 years after surgery

    Time from surgery to death from any cause; living participants are censored at last known follow-up.

  13. Recurrence-Free Survival

    Time frame: Up to 5 years after surgery

    For malignant disease with available follow-up, time from surgery to documented recurrence or death according to the statistical analysis plan definition.

  14. Change in Intracellular Water

    Time frame: T0 to 60 minutes after infusion start

    Intracellular water at T60 minus intracellular water at T0, measured in kilograms and analyzed continuously.

  15. Change in Total Body Water

    Time frame: T0 to 60 minutes after infusion start

    Total body water at T60 minus total body water at T0, measured in kilograms and analyzed continuously.

  16. Change in Extracellular Water to Total Body Water Ratio

    Time frame: T0 to 60 minutes after infusion start

    The device-reported ECW/TBW ratio at T60 minus the ratio at T0, analyzed continuously.

  17. Change in Whole-Body Resistance at 50 kHz

    Time frame: T0 to 60 minutes after infusion start

    Whole-body resistance at 50 kHz at T60 minus resistance at T0, measured in ohms and analyzed continuously.

  18. Change in Whole-Body Reactance at 50 kHz

    Time frame: T0 to 60 minutes after infusion start

    Whole-body reactance at 50 kHz at T60 minus reactance at T0, measured in ohms and analyzed continuously.

  19. Change in Body Weight

    Time frame: T0 to 60 minutes after infusion start

    Body weight at T60 minus body weight at T0, measured in kilograms and analyzed continuously.

Study contacts

Contact information is provided by the study sponsor or research team.

Ognjen Barcot, MD, PhD

CONTACT

[email protected]

+38521556691

Sponsors and collaborators

Lead sponsor

University Hospital of Split

Other

Registry information

Official study 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

Acronym: BIA-HYD-CRC

Important dates

Study start
2026
Primary completion
2028
Study completion
2033
First posted
Sep 16, 2026
Registry last updated
Sep 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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