NCT06097923

Implementation of Fluid Strategies Using Real-time Bioelectrical Analyzer in Surgical Intensive Care Unit (SICU)

Implementation of Fluid Strategies Using Real-time Bioelectrical Analyzer of Postoperative Patients in Surgical Intensive Care Unit (SICU); a Novel Guidance to Set an Ideal Fluid Status of Patient in Acute Postoperative Phase

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Seoul St. Mary's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Precise assessment of postoperative volume status is important to administrate optimal fluid management. Bioelectrical impedance analysis (BIA) which measures the body composition using electric character. Extracellular water (ECW) ratio by BIA represented as the ratio of ECW to total body water (TBW) and is known to reflect the hydration status. Based on this, we aimed to determine whether aggressive fluid control using ECW ratio could improve clinical outcomes through a single blind, randomized controlled trial.

Detailed description

Critically ill patients admitted to an intensive care unit (ICU) after surgery have commonly experienced a large amount of wide organ injury and profuse bleeding resulting in vessel damage during surgery. Severe systemic inflammatory reactions and pathophysiological stress could consequently occur in these patients. For patients in an acute postoperative phase, it is important to maintain organ perfusion by correcting hemodynamic instability through fluid resuscitation. Bioelectrical impedance analysis (BIA), a non-invasive method, is useful for quantitatively measuring body composition such as body fat and muscle mass. It is also useful for evaluating volume status based on resistance and reactance of cells known to have different electrical conductivity according to biological characteristics of body composition. In our previous study using BIA, the results showed that changes in ECW ratio after surgery were related to conventional parameters of overhydrated status such as daily fluid balance or capillary leak index (CLI). In addition, overhydration with value of ECW ratio above 0.390 on 3rd postoperative day appeared to be a risk factor for postoperative morbidity and mortality. Herein, we aim to set the ECW ratio as a guideline for postoperative volume status and confirm a hypothesis that active intervention with fluid management to control the ECW ratio by BIA could lower clinical outcomes in patients with fluid imbalance through a prospective randomized controlled study.

Conditions

• Fluid Overload
• Fluid Loss

Interventions

Type	Name	Description
DRUG	Active fluid management with BIA monitoring	The participants in active fluid management with BIA monitoring arm received fluid supplementation targeting specific range of ECW ratio by BIA (0.390-0.406). If a patient with dehydrated status indicated by the ECW ratio was less than 0.390, a bolus infusion was performed using 250ml of crystalloid fluid (PlasmaLyte). If a patient with overhydrated status indicated by the ECW ratio was more than 0.406, 10mg of furosemide was administered. Changes in the ECW ratio were measured at one hour after initial intervention for fluid adjustment, and these processes continued until the ECW ratio was within the normal range (0.390-0.406).
DRUG	Conventional fluid management without BIA monitoring	The participants in conventional fluid management without BIA monitoring arm underwent conventional fluid management without specific targets of ECW ratio by BIA.

Timeline

• Start date: 2021-11-30
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2023-10-24
• Last updated: 2023-10-24

Locations

1 site across 1 country: South Korea