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Clinical Trials/NCT06498375
NCT06498375
Not yet recruiting
Not Applicable

Fluid Status and Body Composition Analysis in Patients After Cardiac Surgery Assessed by Bioelectrical Impedance Method and Its Impact on Postoperative Morbidity and Mortality

University Medical Centre Ljubljana1 site in 1 country150 target enrollmentJuly 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiopulmonary Disease
Sponsor
University Medical Centre Ljubljana
Enrollment
150
Locations
1
Primary Endpoint
Fluid distribution during the early postoperative period (≤ 5 days)
Status
Not yet recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2024
End Date
July 2026
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Laura Kekec

Principal Investigator

University Medical Centre Ljubljana

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Fluid distribution during the early postoperative period (≤ 5 days)

Time Frame: Perioperative period (preoperatively, on the first, third, and fifth postoperative day)

Bioelectrical impedance vector analysis

Secondary Outcomes

  • 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))

Study Sites (1)

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