BIA-Guided vs. Conventional Fluid Resuscitation in ICU Patients (BIA-FLUID)

Ondokuz Mayıs University

Status: Not yet enrolling

Conditions: Fluid and Electrolyte Imbalance; Anesthesia

Treatments: Device: Bioelectrical Impedance Analysis (BCM); Procedure: Conventional Fluid Management

Study type: Interventional

Funder types: Other

Identifiers

NCT07142083

BIA2024

Details and patient eligibility

About

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.

Full description

Fluid resuscitation plays a critical role in the perioperative care of patients undergoing major surgery.

Traditionally, fluid therapy decisions in the intensive care unit (ICU) have relied on static clinical parameters, which may not always reflect the patient's actual volume status. Bioelectrical impedance analysis (BIA) offers a noninvasive and dynamic assessment of hydration status, enabling more precise fluid management tailored to individual needs. This prospective, randomized controlled study aims to compare BIA-guided fluid resuscitation with conventional fluid management strategies in postoperative ICU patients. A total of 80 adult patients who meet the inclusion criteria will be randomized into two groups. Group 1 will receive standard fluid therapy based on clinical evaluation, including heart rate, blood pressure, urine output, passive leg raising test, and vena cava ultrasound assessment. Group 2 will undergo BIA measurements at 0, 12, 24, and 48 hours post-ICU admission to guide fluid management according to hydration status (dehydrated, euvolemic, or hypervolemic). The primary outcome is 28-day all-cause mortality. Secondary outcomes include cumulative fluid balance, ICU and hospital length of stay, duration of mechanical ventilation, and need for vasopressors or inotropic agents. By evaluating clinical outcomes between the two approaches, this study seeks to determine whether BIA-guided fluid management offers a clinically meaningful advantage in postoperative critical care.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

BIA-Guided Fluid Therapy

Experimental group

Description:

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.

Treatment:

Device: Bioelectrical Impedance Analysis (BCM)

Conventional Fluid Therapy

Active Comparator group

Description:

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.

Treatment:

Procedure: Conventional Fluid Management