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

July 4, 2024 updated by: Laura Kekec, University Medical Centre Ljubljana

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Slovenia
      • Ljubljana, Slovenia
        • Department of Anaesthesiology and Surgical Intensive Care, University Medical Centre Ljubljana
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults (18 years or over) undergoing elective cardovascular surgery (on-pump or off-pump)

Description

Inclusion criteria

  1. Elective cardiovascular surgery (on-pump or off-pump)
  2. Age ≥ 18 years
  3. ASA 3 or 4
  4. Provided verbal and written informed consent

Exclusion criteria

  1. Refusal to participate in the research
  2. < 18 years
  3. Renal failure requiring replacement treatment with hemodialysis
  4. Amputation of a limb
  5. Pregnancy
  6. Emergency Procedures
  7. Reoperation
  8. Pacemaker/implantable cardioverter-defibrillator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
On-pump cardiac surgery
Patients undergoing cardiac surgery with cardiopulmonary bypass
Diagnostic test: Bioelectrical impedance
Fluid distribution measured by bioelectrical impedance Bodystat Multiscan 5000 Bodystat Ltd, Isle of Man, British Isles
Off-pump cardiac surgery
Patients undergoing cardiac surgery without cardiopulmonary bypass
Diagnostic test: Bioelectrical impedance
Fluid distribution measured by bioelectrical impedance Bodystat Multiscan 5000 Bodystat Ltd, Isle of Man, British Isles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fluid distribution during the early postoperative period (≤ 5 days)
Time Frame: Perioperative period (preoperatively, on the first, third, and fifth postoperative day)
Phase angle (in degrees)
Perioperative period (preoperatively, on the first, third, and fifth postoperative day)
Fluid distribution during the early postoperative period (≤ 5 days)
Time Frame: Perioperative period (preoperatively, on the first, third, and fifth postoperative day)
Impedance ratio
Perioperative period (preoperatively, on the first, third, and fifth postoperative day)
Fluid distribution during the early postoperative period (≤ 5 days)
Time Frame: Perioperative period (preoperatively, on the first, third, and fifth postoperative day)
Total body water (TBW), extracellular water (ECW), intracellular water (ICW) (in litres)
Perioperative period (preoperatively, on the first, third, and fifth postoperative day)
Fluid distribution during the early postoperative period (≤ 5 days)
Time Frame: Perioperative period (preoperatively, on the first, third, and fifth postoperative day)
Oedema index (ECW/TBW ratio)
Perioperative period (preoperatively, on the first, third, and fifth postoperative day)
Fluid distribution during the early postoperative period (≤ 5 days)
Time Frame: Perioperative period (preoperatively, on the first, third, and fifth postoperative day)
Body cell mass (in kilograms)
Perioperative period (preoperatively, on the first, third, and fifth postoperative day)
Fluid distribution during the early postoperative period (≤ 5 days)
Time Frame: Perioperative period (preoperatively, on the first, third, and fifth postoperative day)
Skeletal muscle mass (in kilograms)
Perioperative period (preoperatively, on the first, third, and fifth postoperative day)
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
Perioperative period (preoperatively, on the first, third, and fifth postoperative day)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Centre Ljubljana

Investigators

  • Study Chair: Gordana Taleska Štupica, MD, PhD, DESA, EDIC, Department of Anaesthesiology and Surgical Intensive Care, University Medical Centre Ljubljana
  • Principal Investigator: Laura Kekec, MD, Department of Anaesthesiology and Surgical Intensive Care, University Medical Centre Ljubljana
  • Study Director: Matej Jenko, MD, Department of Anaesthesiology and Surgical Intensive Care, University Medical Centre Ljubljana
  • Study Director: Maja Šoštarič, MD, PhD, Department of Anaesthesiology and Surgical Intensive Care, University Medical Centre Ljubljana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

June 26, 2024

First Submitted That Met QC Criteria

July 4, 2024

First Posted (Actual)

July 12, 2024

Study Record Updates

Last Update Posted (Actual)

July 12, 2024

Last Update Submitted That Met QC Criteria

July 4, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TP 20230216

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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