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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06498375
Acronym
FLUBIACS
Enrollment
150
Registered
2024-07-12
Start date
2024-07-31
Completion date
2026-07-31
Last updated
2024-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiopulmonary Disease, Fluid Overload

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.

Interventions

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

Sponsors

University Medical Centre Ljubljana
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Fluid distribution during the early postoperative period (≤ 5 days)Perioperative period (preoperatively, on the first, third, and fifth postoperative day)Phase angle (in degrees)

Secondary

MeasureTime frame
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 unitDuration of stay in ICU (estimated to up to 5 days)
Impact of fluid distribution/fluid overload on duration of postoperative mechanical ventilationDuration of stay in ICU (estimated to up to 5 days)
Impact of fluid distribution/fluid overload on 30-day postoperative mortalityOn day 30
Impact of fluid distribution/fluid overload on 1-year postoperative mortalityAt 1 year postoperatively
Impact of fluid distribution/fluid overload on length of hospitalisationDuration of hospital stay (up to 1 month)

Countries

Slovenia

Contacts

Primary ContactLaura Kekec
laura.kekec@kclj.si+38640205330

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026