BIA-Guided vs. Conventional Fluid Resuscitation in ICU Patients

NCT07142083 | Not Yet Recruiting

• 1 other identifier: BIA2024
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

In this study aimed to compare bioelectrical impedance analysis (BIA)-guided fluid resuscitation with conventional fluid management strategies in patients admitted to the intensive care unit (ICU) following major surgery. The primary objective is to evaluate whether BIA-guided fluid therapy reduces 28-day mortality by optimizing fluid balance and preventing volume-related complications. Secondary outcomes include cumulative fluid balance, ICU and hospital length of stay, duration of mechanical ventilation, and need for vasopressor or inotropic support. This study is expected to provide evidence for the clinical utility and applicability of BIA in guiding postoperative fluid therapy in critically ill patients.

Conditions

Fluid and Electrolyte Imbalance; Anesthesia

Keywords

Bioelectrical impedance analysis; Intensive Care; Fluid Resuscitation; Postoperative Fluid Management

Outcome Measures

Primary Outcomes (1)

• 28-day all-cause mortality

  The number of participants in each group who die from any cause within 28 days after admission to the intensive care unit (ICU) following major surgery. The primary comparison will be between patients receiving bioelectrical impedance analysis (BIA)-guided fluid therapy and those receiving conventional fluid management.

  postoperative 28 days

Secondary Outcomes (5)

• Cumulative fluid balance

  First 48 hours after ICU admission

• ICU length of stay

  The time from admission to the ICU to the time of discharge to the hospital ward; during the hospital stay, an average of 28 days

• Hospital length of stay

  Measured in days admitted in the hospital, an average of 28 days

• Duration of mechanical ventilation

  First 48 hours after ICU admission

• Requirement for inotropic support

  First 48 hours after ICU admission

Study Arms (2)

BIA-Guided Fluid Therapy

EXPERIMENTAL

Patients in this group will receive postoperative fluid therapy guided by bioelectrical impedance analysis (BIA) using the Body Composition Monitor (BCM) device. Daily fluid decisions will be based on measurements such as Extracellular water (ECW)/ Total body water (TBW) and phase angle.

Device: Bioelectrical Impedance Analysis (BCM)

Conventional Fluid Therapy

ACTIVE COMPARATOR

Patients in this group will receive conventional fluid management based on routine clinical parameters, including vital signs, urine output, physical examination, and laboratory values. No bioelectrical impedance analysis will be performed in this group.

Procedure: Conventional Fluid Management

Interventions

Bioelectrical Impedance Analysis (BCM) DEVICE

The Body Composition Monitor (BCM) device will be used to perform daily bioelectrical impedance measurements to guide fluid resuscitation in critically ill patients after major surgery. Measurements include extracellular water, intracellular water, total body water, and phase angle. The results will be used to tailor fluid therapy.

BIA-Guided Fluid Therapy

Conventional Fluid Management PROCEDURE

Patients in this group will receive fluid therapy based on standard clinical parameters including blood pressure, heart rate, urine output, laboratory values, and physical examination. No bioelectrical impedance measurement will be performed.

Conventional Fluid Therapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Undergoing major surgery under general anesthesia(Major surgery defined as: vascular clamping or organ ischemia, intraoperative blood loss \>1000 mL, need for \>10 mcg/min norepinephrine infusion, surgery duration \>4 hours, or requirement for perioperative blood transfusion)
• Admission to the intensive care unit (CU) after surgery
• Informed consent obtained

You may not qualify if:

• Refusal to participate or failure to provide informed consent
• Undergoing laparoscopic or emergency surgery
• Severe major organ dysfunction:Acute kidney injury stage 2 or 3 (KDIGO 2012) • Acute or chronic liver failure (ALT \>3x or Child A-C cirrhosis
• Conditions preventing accurate BIA measurement: • Limb amputation • Metallic cardiac or joint prostheses • Pacemakers or intracardiac stents
• Body mass index \>35 kg/m or \< 18 kg/m
• Contraindications to lactated Ringer's solution (e.g. hypercalcemia, increased intracranial pressure)

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Related Publications (4)

• Chung YJ, Kim EY. Usefulness of bioelectrical impedance analysis and ECW ratio as a guidance for fluid management in critically ill patients after operation. Sci Rep. 2021 Jun 9;11(1):12168. doi: 10.1038/s41598-021-91819-7.

  PMID: 34108597 BACKGROUND

• Myatchin I, Abraham P, Malbrain MLNG. Bio-electrical impedance analysis in critically ill patients: are we ready for prime time? J Clin Monit Comput. 2020 Jun;34(3):401-410. doi: 10.1007/s10877-019-00439-0. Epub 2019 Dec 5. No abstract available.

  PMID: 31808061 BACKGROUND

• Wang K, Sun SL, Wang XY, Chu CN, Duan ZH, Yang C, Liu BC, Ding WW, Li WQ, Li JS. Bioelectrical impedance analysis-guided fluid management promotes primary fascial closure after open abdomen: a randomized controlled trial. Mil Med Res. 2021 Jun 7;8(1):36. doi: 10.1186/s40779-021-00329-0.

  PMID: 34099065 BACKGROUND

• Basso F, Berdin G, Virzi GM, Mason G, Piccinni P, Day S, Cruz DN, Wjewodzka M, Giuliani A, Brendolan A, Ronco C. Fluid management in the intensive care unit: bioelectrical impedance vector analysis as a tool to assess hydration status and optimal fluid balance in critically ill patients. Blood Purif. 2013;36(3-4):192-9. doi: 10.1159/000356366. Epub 2013 Dec 20.

  PMID: 24496190 BACKGROUND

Study Officials

• Fatma Ülger

  Ondokuz Mayıs University

  STUDY DIRECTOR

Central Study Contacts

Kübra Tabur

CONTACT

+905396067171; ddoktortas@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: To preserve the integrity of the study results, group assignments (BIA-guided fluid resuscitation vs. conventional fluid resuscitation) were concealed from the clinical staff involved in patient care and data collection. In addition, the investigators responsible for evaluating the primary and secondary outcomes (outcome assessors) were blinded to group allocation. Prior to participation, all patients or their legal representatives were thoroughly informed about the study's purpose, the nature of the two fluid management strategies, the randomization process, and the blinding of group information. Informed consent was obtained after ensuring full understanding of the methodology, including the confidentiality of group assignments.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ondokuz Mayıs University

Model Details: A computer-generated block randomization list will be created using an online randomization tool by a researcher who is not involved in patient treatment or follow-up. Patients will be assigned to one of two groups (BIA-guided fluid management or conventional fluid therapy) based on sealed opaque envelopes prepared in advance according to the randomization sequence.

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 26, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share