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

NCT06097923 | Completed

• 1 other identifier: BIA_03
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fluid Overload; Fluid Loss

Outcome Measures

Primary Outcomes (1)

• In-hospital mortality rate

  Proportion of patients who died during the hospitalization period among participants

  Participants were followed upto 28th day after surgery

Secondary Outcomes (2)

• Incidence of postoperative morbidities

  Participants were followed upto 28th day after surgery

• 28-day mortality rate

  Participants were followed upto 28th day after surgery

Study Arms (2)

Active fluid management with BIA monitoring

EXPERIMENTAL

For assessment of fluid status, a commercial portable BIA device (InBody M20®, InBody Corp., Seoul, Korea) was measured. Baseline BIA data were collected at the time of ICU admission, and BIA measurements were performed daily for 3days for all participants. 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 the investigators determined whether additional intervention was needed according to results of changes. These processes continued until the ECW ratio was within the normal range (0.390-0.406).

Drug: Active fluid management with BIA monitoring

Conventional fluid management without BIA monitoring

EXPERIMENTAL

For assessment of fluid status, a commercial portable BIA device with 5-kilohertz, 50-kilohertz, and 250-kilohertz alternating current (InBody M20®, InBody Corp., Seoul, Korea) was measured. Baseline BIA data were collected at the time of ICU admission. Thereafter, BIA measurements were performed daily for 3 days for all participants. The participants in conventional fluid management without BIA monitoring arm underwent conventional fluid management without specific targets of ECW ratio by BIA.

Drug: Conventional fluid management without BIA monitoring

Interventions

Active fluid management with BIA monitoring DRUG

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).

Active fluid management with BIA monitoring

Conventional fluid management without BIA monitoring DRUG

The participants in conventional fluid management without BIA monitoring arm underwent conventional fluid management without specific targets of ECW ratio by BIA.

Conventional fluid management without BIA monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients admitted to the surgical ICU after surgery under general anesthesia regardless of the type of surgery
• Patients who showed abnormal range of baseline ECW ratio by BIA (less than 0.390 or more than 0.405) that measured at the time of ICU admission

You may not qualify if:

• aged under 18 years
• underwent surgery under local or regional anesthesia
• pregnant
• had bone fixation or underwent limb amputation
• had any prosthetic medical devices such as pacemaker or metallic intravascular device
• stayed in ICU for less than 48 hours
• readmitted within 48 hours after ICU discharge
• diagnosed with renal failure and receiving renal replacement therapy
• underwent extracorporeal membrane oxygenation treatment before surgery
• agreed for do-not-resuscitate

Sponsors & Collaborators

• Seoul St. Mary's Hospital: lead

Study Sites (1)

Division of Trauma and Surgical Critical Care, Department of Surgery, Seoul St. Mary's Hospital

Seoul, Seocho-gu, Banpo-dong Banpodaero 222, 137-701, South Korea

Location

Related Publications (1)

• Chung YJ, Lee GR, Kim HS, Kim EY. Effect of rigorous fluid management using monitoring of ECW ratio by bioelectrical impedance analysis in critically ill postoperative patients: A prospective, single-blind, randomized controlled study. Clin Nutr. 2024 Sep;43(9):2164-2176. doi: 10.1016/j.clnu.2024.07.040. Epub 2024 Jul 31.

  PMID: 39142110 DERIVED

MeSH Terms

Conditions

Edema

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: October 24, 2023
• Study Start: November 30, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: October 24, 2023

Record last verified: 2023-10

Locations

KR (1)