Clinical trial
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
Name
BIA_03
Description
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.
Trial arms
Trial start
2021-11-30
Estimated PCD
2022-12-31
Trial end
2022-12-31
Status
Completed
Treatment
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).
Arms:
Active fluid management with BIA monitoring
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.
Arms:
Conventional fluid management without BIA monitoring
Size
200
Primary endpoint
In-hospital mortality rate
Participants were followed upto 28th day after surgery
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 200, 'type': 'ACTUAL'}}
Updated at
2023-10-24
1 organization
2 products
2 indications
Organization
Seoul St. Mary's HospitalIndication
Fluid OverloadIndication
Dehydration