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

NCT ID: NCT06498375

Last Updated: 2024-07-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-31
• Study Completion Date: 2026-07-31

Brief Summary

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

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.

Conditions

Cardiopulmonary Disease; Fluid Overload

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

On-pump cardiac surgery

Patients undergoing cardiac surgery with cardiopulmonary bypass

Bioelectrical impedance

Intervention Type: DIAGNOSTIC_TEST

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

Bioelectrical impedance

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Bioelectrical impedance

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Centre Ljubljana

OTHER

Sponsor Role: lead

Responsible Party

Laura Kekec

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gordana Taleska Štupica, MD, PhD, DESA, EDIC

Role: STUDY_CHAIR

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

Laura Kekec, MD

Role: PRINCIPAL_INVESTIGATOR

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

Matej Jenko, MD

Role: STUDY_DIRECTOR

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

Maja Šoštarič, MD, PhD

Role: STUDY_DIRECTOR

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

Locations

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

Ljubljana, , Slovenia

Countries

Slovenia

Central Contacts

Laura Kekec

Role: CONTACT

laura.kekec@kclj.si

+38640205330

Facility Contacts

Tomislav Mirkovič

Role: primary

predstojnik.koait@kclj.si

Other Identifiers

TP 20230216

Identifier Type: -

Identifier Source: org_study_id