Clinical trial NCT06097923: Implementation of Fluid Strategies Using Real-time Bioelectrical Analyzer in Surgical Intensive Care Unit (SICU)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fluid Overload
Fluid Loss
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
First posted: 2023-10-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: In-hospital mortality rate
timeFrame: Participants were followed upto 28th day after surgery
Secondary outcomes:
measure: Incidence of postoperative morbidities
timeFrame: Participants were followed upto 28th day after surgery
measure: 28-day mortality rate
timeFrame: Participants were followed upto 28th day after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Trauma and Surgical Critical Care, Department of Surgery, Seoul St. Mary's Hospital
state: Seocho-gu, Banpo-dong Banpodaero 222
Study officials:
References: