NCT06498375 - Fluid Status and Body Composition Analysis by Bioelectrical Impedance in Patients After Cardiac Surgery (FLUBIACS) | Crick | Crick

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

N/ANot Yet RecruitingNCT06498375

University Medical Centre Ljubljana150 enrolled

Overview

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

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

150

Conditions

Cardiopulmonary Disease Fluid Overload

Interventions

Bioelectrical impedanceDIAGNOSTIC_TEST

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

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

Ljubljana, Slovenia

Outcomes

Primary Outcomes

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

Phase angle (in degrees)

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

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

Impedance ratio

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

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

Total body water (TBW), extracellular water (ECW), intracellular water (ICW) (in litres)

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

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

Oedema index (ECW/TBW ratio)

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

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

Body cell mass (in kilograms)

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

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

Skeletal muscle mass (in kilograms)

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

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

Bioelectrical impedance vector analysis

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

Central Contacts

Laura Kekec

CONTACT

+38640205330 laura.kekec@kclj.si

Data from ClinicalTrials.gov

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