Clinical trial NCT06498375: Fluid Status and Body Composition Analysis by Bioelectrical Impedance in Patients After Cardiac Surgery (FLUBIACS)
Official title: Fluid Status and Body Composition Analysis in Patients After Cardiac Surgery Assessed by Bioelectrical Impedance Method and Its Impact on Postoperative Morbidity and Mortality
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cardiopulmonary Disease
Fluid Overload
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2024-07-12
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults (18 years or over) undergoing elective cardovascular surgery (on-pump or off-pump)

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.

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

Primary outcomes:
measure: Fluid distribution during the early postoperative period (≤ 5 days)
timeFrame: Perioperative period (preoperatively, on the first, third, and fifth postoperative day)
measure: Fluid distribution during the early postoperative period (≤ 5 days)
timeFrame: Perioperative period (preoperatively, on the first, third, and fifth postoperative day)
measure: Fluid distribution during the early postoperative period (≤ 5 days)
timeFrame: Perioperative period (preoperatively, on the first, third, and fifth postoperative day)
measure: Fluid distribution during the early postoperative period (≤ 5 days)
timeFrame: Perioperative period (preoperatively, on the first, third, and fifth postoperative day)
measure: Fluid distribution during the early postoperative period (≤ 5 days)
timeFrame: Perioperative period (preoperatively, on the first, third, and fifth postoperative day)
measure: Fluid distribution during the early postoperative period (≤ 5 days)
timeFrame: Perioperative period (preoperatively, on the first, third, and fifth postoperative day)
measure: Fluid distribution during the early postoperative period (≤ 5 days)
timeFrame: Perioperative period (preoperatively, on the first, third, and fifth postoperative day)
Secondary outcomes:
measure: Impact of fluid distribution/fluid overload on duration of postoperative mechanical ventilation
timeFrame: Duration of stay in ICU (estimated to up to 5 days)
measure: Impact of fluid distribution/fluid overload on postoperative complications (myocardial infarction, cardiogenic shock, vasoplegia, atrial fibrillation, heart failure, bleeding, infections, delirium)
timeFrame: Up to 1 year after the operation
measure: Impact of fluid distribution/fluid overload on length of stay in the intensive care unit
timeFrame: Duration of stay in ICU (estimated to up to 5 days)
measure: Impact of fluid distribution/fluid overload on length of hospitalisation
timeFrame: Duration of hospital stay (up to 1 month)
measure: Impact of fluid distribution/fluid overload on 30-day postoperative mortality
timeFrame: On day 30
measure: Impact of fluid distribution/fluid overload on 1-year postoperative mortality
timeFrame: At 1 year postoperatively
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: Department of Anaesthesiology and Surgical Intensive Care, University Medical Centre Ljubljana
Study officials:
affiliation: Department of Anaesthesiology and Surgical Intensive Care, University Medical Centre Ljubljana
name: Gordana Taleska Štupica, MD, PhD, DESA, EDIC
role: STUDY_CHAIR
affiliation: Department of Anaesthesiology and Surgical Intensive Care, University Medical Centre Ljubljana
name: Laura Kekec, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anaesthesiology and Surgical Intensive Care, University Medical Centre Ljubljana
name: Matej Jenko, MD
role: STUDY_DIRECTOR
affiliation: Department of Anaesthesiology and Surgical Intensive Care, University Medical Centre Ljubljana
name: Maja Šoštarič, MD, PhD
role: STUDY_DIRECTOR
References: