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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 80
- Primary Endpoint
- 28-day all-cause mortality
Study Overview
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Investigator, Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
BIA-Guided Fluid Therapy
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.
Intervention: Bioelectrical Impedance Analysis (BCM) (Device)
Conventional Fluid Therapy
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.
Intervention: Conventional Fluid Management (Procedure)
Outcomes
Primary Outcomes
28-day all-cause mortality
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.
Secondary Outcomes
- Cumulative fluid balance(First 48 hours after ICU admission)
- Hospital length of stay(Measured in days admitted in the hospital, an average of 28 days)
- 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)
- Duration of mechanical ventilation(First 48 hours after ICU admission)
- Requirement for inotropic support(First 48 hours after ICU admission)
Investigators
Fatma ULGER
Ondokuz Mayıs University
Ondokuz Mayıs University