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

NCT06498375 | Not Yet Recruiting DMC

• 1 other identifier: TP 20230216
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cardiopulmonary Disease; Fluid Overload

Outcome Measures

Primary Outcomes (7)

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

  Phase angle (in degrees)

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

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

  Impedance ratio

  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)

  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)

  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)

  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)

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

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

  Bioelectrical impedance vector analysis

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

Secondary Outcomes (6)

• 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 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 stay in the intensive care unit

  Duration of stay in ICU (estimated to up to 5 days)

• Impact of fluid distribution/fluid overload on length of hospitalisation

  Duration of hospital stay (up to 1 month)

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

  On day 30

Study Arms (2)

On-pump cardiac surgery

Patients undergoing cardiac surgery with cardiopulmonary bypass

Diagnostic Test: Bioelectrical impedance

Off-pump cardiac surgery

Patients undergoing cardiac surgery without cardiopulmonary bypass

Diagnostic Test: Bioelectrical impedance

Interventions

Bioelectrical impedance DIAGNOSTIC_TEST

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

Off-pump cardiac surgery; On-pump cardiac surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

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

Ljubljana, Slovenia

Location

MeSH Terms

Conditions

Pulmonary Heart Disease; Edema

Interventions

Electric Impedance

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Conductivity; Electricity; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena

Study Officials

• Gordana Taleska Štupica, MD, PhD, DESA, EDIC

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

  STUDY CHAIR

• Laura Kekec, MD

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

  PRINCIPAL INVESTIGATOR

• 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 DIRECTOR

Central Study Contacts

Laura Kekec

CONTACT

+38640205330; laura.kekec@kclj.si

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 12, 2024
• Study Start: July 1, 2024
• Primary Completion: July 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 12, 2024

Record last verified: 2024-07

Locations

SL (1)