NCT Number: NCT07142083
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.
Trial opening soon.
Get Notified18 year–60 year
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: postoperative 28 days
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: First 48 hours after ICU admission
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: 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
The number of days each patient remains in the intensive care unit after major surgery, from admission to discharge from the ICU.
Time frame: Measured in days admitted in the hospital, an average of 28 days
The total number of days from the patient's admission to the hospital (including ICU and ward stay) until discharge or death.
Time frame: First 48 hours after ICU admission
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
The number of patients in each group requiring any inotropic or vasopressor therapy during the ICU stay. The type, dose, and duration of inotropic support will be recorded.
Contact information is provided by the study sponsor or research team.
Ondokuz Mayıs University
Other
Comparison of the Effects of Bioelectrical Impedance Analysis-Guided Versus Conventional Fluid Resuscitation Strategies on 28-Day Mortality in Intensive Care Unit Patients After Major Surgery
Acronym: BIA-FLUID
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