Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06498375

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

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Cardiopulmonary Disease Cardiovascular Diseases Edema Fluid Overload Heart Diseases Pathological Conditions, Signs and Symptoms Pulmonary Heart Disease Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anaesthesiology and Surgical Intensive Care, University Medical Centre Ljubljana

Ljubljana, Slovenia

Location contact

Tomislav Mirkovič

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Refusal to participate in the research
  • < 18 years
  • Renal failure requiring replacement treatment with hemodialysis
  • Amputation of a limb
  • Pregnancy
  • Emergency Procedures
  • Reoperation
  • Pacemaker/implantable cardioverter-defibrillator

Treatment and study plan

Bioelectrical impedance

Diagnostic Test

Fluid distribution measured by bioelectrical impedance Bodystat Multiscan 5000 Bodystat Ltd, Isle of Man, British Isles

Primary outcomes

  1. 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)

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

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

    Impedance ratio

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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

  1. 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)

  2. 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

  3. 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)

  4. Impact of fluid distribution/fluid overload on length of hospitalisation

    Time frame: Duration of hospital stay (up to 1 month)

  5. Impact of fluid distribution/fluid overload on 30-day postoperative mortality

    Time frame: On day 30

  6. Impact of fluid distribution/fluid overload on 1-year postoperative mortality

    Time frame: At 1 year postoperatively

Study contacts

Contact information is provided by the study sponsor or research team.

Laura Kekec

CONTACT

[email protected]

+38640205330

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Official study title

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

Acronym: FLUBIACS

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jul 12, 2024
Registry last updated
Jul 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.