Fluid Status and Body Composition Analysis in Patients After Cardiac Surgery Assessed by Bioelectrical Impedance Method and Its Impact on Postoperative Morbidity and Mortality
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-Summary
Evaluation of fluid status in cardiac surgery patients using bioelectrical impedance and its impact on postoperative morbidity and mortality
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+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.
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| On-pump cardiac surgery | | Diagnostic Test: Bioelectrical impedance | Patients undergoing cardiac surgery with cardiopulmonary bypass |
| Off-pump cardiac surgery | | Diagnostic Test: Bioelectrical impedance | Patients undergoing cardiac surgery without cardiopulmonary bypass |
- Bioelectrical impedance (Diagnostic test): Fluid distribution measured by bioelectrical impedance Bodystat Multiscan 5000 Bodystat Ltd, Isle of Man, British Isles
+Outcome measures
Primary outcomes
- Fluid distribution during the early postoperative period (≤ 5 days) [Perioperative period (preoperatively, on the first, third, and fifth postoperative day)]: Phase angle (in degrees)
- Fluid distribution during the early postoperative period (≤ 5 days) [Perioperative period (preoperatively, on the first, third, and fifth postoperative day)]: Impedance ratio
- Fluid distribution during the early postoperative period (≤ 5 days) [Perioperative period (preoperatively, on the first, third, and fifth postoperative day)]: Total body water (TBW), extracellular water (ECW), intracellular water (ICW) (in litres)
- Fluid distribution during the early postoperative period (≤ 5 days) [Perioperative period (preoperatively, on the first, third, and fifth postoperative day)]: Oedema index (ECW/TBW ratio)
- Fluid distribution during the early postoperative period (≤ 5 days) [Perioperative period (preoperatively, on the first, third, and fifth postoperative day)]: Body cell mass (in kilograms)
- Fluid distribution during the early postoperative period (≤ 5 days) [Perioperative period (preoperatively, on the first, third, and fifth postoperative day)]: Skeletal muscle mass (in kilograms)
- Fluid distribution during the early postoperative period (≤ 5 days) [Perioperative period (preoperatively, on the first, third, and fifth postoperative day)]: Bioelectrical impedance vector analysis
Secondary outcomes
- 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]
- Impact of fluid distribution/fluid overload on 1-year postoperative mortality [At 1 year postoperatively]
+Eligibility
Sex: All, ages: 18 Years to any
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)
| Facility | City | Country | Status |
|---|
| Department of Anaesthesiology and Surgical Intensive Care, University Medical Centre Ljubljana | Ljubljana | Slovenia | |
+Investigators
- Gordana Taleska Štupica, MD, PhD, DESA, EDIC, Study chair, Department of Anaesthesiology and Surgical Intensive Care, University Medical Centre Ljubljana
- Laura Kekec, MD, Principal investigator, Department of Anaesthesiology and Surgical Intensive Care, University Medical Centre Ljubljana
- Matej Jenko, MD, Study director, Department of Anaesthesiology and Surgical Intensive Care, University Medical Centre Ljubljana
- Maja Šoštarič, MD, PhD, Study director, Department of Anaesthesiology and Surgical Intensive Care, University Medical Centre Ljubljana