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BIA-Guided vs. Conventional Fluid Resuscitation in ICU Patients

ConditionsFluid and Electrolyte ImbalanceAnesthesia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorOndokuz Mayıs University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Conventional Fluid Management

    Procedure/Surgery

    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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: BIA-Guided Fluid TherapyExperimental treatment 1 intervention
Group B: Conventional Fluid TherapyActive comparator 1 intervention

Trial outcomes

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.

Time frame
postoperative 28 days

Secondary outcomes

1

Cumulative fluid balance

Total fluid input minus total fluid output calculated cumulatively for each patient during ICU stay. Fluid balance will be recorded daily and evaluated within the first 48 hours after ICU admission.

Time frame
First 48 hours after ICU admission
2

ICU length of stay

The number of days each patient remains in the intensive care unit after major surgery, from admission to discharge from the ICU.

Time frame
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
3

Hospital length of stay

The total number of days from the patient's admission to the hospital (including ICU and ward stay) until discharge or death.

Time frame
Measured in days admitted in the hospital, an average of 28 days
4

Duration of mechanical ventilation

Total number of hours each patient remains on invasive mechanical ventilation during the first 48 hours of ICU follow-up.

Time frame
First 48 hours after ICU admission

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ondokuz Mayıs University

Lead sponsor

Source ClinicalTrials.gov

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