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

NCT ID: NCT06097923

Last Updated: 2023-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-30
• Study Completion Date: 2022-12-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Active fluid management with BIA monitoring

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).

Group Type: EXPERIMENTAL

Active fluid management with BIA monitoring

Intervention Type: 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).

Conventional fluid management without BIA monitoring

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.

Group Type: EXPERIMENTAL

Conventional fluid management without BIA monitoring

Intervention Type: DRUG

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

Interventions

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).

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul St. Mary's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Eun Young Kim

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

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

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 39142110 (View on PubMed)

Other Identifiers

BIA_03

Identifier Type: -

Identifier Source: org_study_id