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

U

University Medical Centre Ljubljana

Status

Not yet enrolling

Conditions

Cardiopulmonary Disease
Fluid Overload

Treatments

Diagnostic Test: Bioelectrical impedance

Study type

Observational

Funder types

Other

Identifiers

NCT06498375
TP 20230216

Details and patient eligibility

About

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

Full 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.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

150 participants in 2 patient groups

On-pump cardiac surgery
Description:
Patients undergoing cardiac surgery with cardiopulmonary bypass
Treatment:
Diagnostic Test: Bioelectrical impedance
Off-pump cardiac surgery
Description:
Patients undergoing cardiac surgery without cardiopulmonary bypass
Treatment:
Diagnostic Test: Bioelectrical impedance

Trial contacts and locations

1

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Central trial contact

Laura Kekec

Data sourced from clinicaltrials.gov

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