BIA-Guided vs. Conventional Fluid Resuscitation in ICU Patients

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Bioelectrical Impedance Analysis (BCM)
  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.
• Процедура Conventional Fluid Management
  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.

Первичные конечные точки

• 28-day all-cause mortality [Срок оценки: postoperative 28 days]

Вторичные конечные точки (5)

• Cumulative fluid balance [Срок оценки: First 48 hours after ICU admission]
• ICU length of stay [Срок оценки: 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 [Срок оценки: Measured in days admitted in the hospital, an average of 28 days]
• Duration of mechanical ventilation [Срок оценки: First 48 hours after ICU admission]
• Requirement for inotropic support [Срок оценки: First 48 hours after ICU admission]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07142083 · BIA2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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