Fluid Status and Body Composition Analysis by Bioelectrical Impedance in Patients After Cardiac Surgery (FLUBIACS)

Not yet recruiting

• Conditions: Cardiopulmonary Disease; Fluid Overload
• Interventions: Diagnostic Test: Bioelectrical impedance

• Registration Number: NCT06498375
• Lead Sponsor: University Medical Centre Ljubljana

Brief Summary

Evaluation of fluid status in cardiac surgery patients using bioelectrical impedance and its impact on postoperative morbidity and mortality

Detailed Description

Hydration and fluid balance dynamics after cardiac surgery is complex and requires comprehensive knowledge of bluid balance dynamics. Surgical trauma, anaesthesia and use of cardiopulmonary bypass significantly influence postoperative fluid status. Deviations from normal values on the other hand can be related to increase in morbidity and mortality.

The purpose of this prospective observational clinical study is to assess fluid status using bioelectric impedance in patients undergoing cardiac surgery and to evaluate its impact on postoperative morbidity and mortality.

Study Timeline

• Study First Submitted: 2024-06-26
• Status Verified: 2024-07
• Study Start: 2024-07
• Study First Submitted QC: 2024-07-04
• Last Update Submitted: 2024-07-04
• Study First Posted: 2024-07-12
• Last Update Posted: 2024-07-12
• Primary Completion: 2025-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Off-pump cardiac surgery	Bioelectrical impedance	Patients undergoing cardiac surgery without cardiopulmonary bypass
On-pump cardiac surgery	Bioelectrical impedance	Patients undergoing cardiac surgery with cardiopulmonary bypass

Primary Outcome Measures

Name	Time	Method
Fluid distribution during the early postoperative period (≤ 5 days)	Perioperative period (preoperatively, on the first, third, and fifth postoperative day)	Bioelectrical impedance vector analysis

Secondary Outcome Measures

Name	Time	Method
Impact of fluid distribution/fluid overload on 30-day postoperative mortality	On day 30
Impact of fluid distribution/fluid overload on duration of postoperative mechanical ventilation	Duration of stay in ICU (estimated to up to 5 days)
Impact of fluid distribution/fluid overload on length of stay in the intensive care unit	Duration of stay in ICU (estimated to up to 5 days)
Impact of fluid distribution/fluid overload on 1-year postoperative mortality	At 1 year postoperatively
Impact of fluid distribution/fluid overload on postoperative complications (myocardial infarction, cardiogenic shock, vasoplegia, atrial fibrillation, heart failure, bleeding, infections, delirium)	Up to 1 year after the operation
Impact of fluid distribution/fluid overload on length of hospitalisation	Duration of hospital stay (up to 1 month)

Trial Locations

Locations (1)

Department of Anaesthesiology and Surgical Intensive Care, University Medical Centre Ljubljana; 🇸🇮 Ljubljana, Slovenia