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Evaluation of fluid status in cardiac surgery patients using bioelectrical impedance and its impact on postoperative morbidity and mortality
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| On-pump cardiac surgery | Patients undergoing cardiac surgery with cardiopulmonary bypass |
| |
| Off-pump cardiac surgery | Patients undergoing cardiac surgery without cardiopulmonary bypass |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bioelectrical impedance | Diagnostic Test | Fluid distribution measured by bioelectrical impedance Bodystat Multiscan 5000 Bodystat Ltd, Isle of Man, British Isles |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion criteria
Exclusion criteria
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Adults (18 years or over) undergoing elective cardovascular surgery (on-pump or off-pump)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laura Kekec | Contact | +38640205330 | laura.kekec@kclj.si |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anaesthesiology and Surgical Intensive Care, University Medical Centre Ljubljana | Ljubljana | Slovenia |
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| ID | Term |
|---|---|
| D011660 | Pulmonary Heart Disease |
| D004487 | Edema |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017097 | Electric Impedance |
| ID | Term |
|---|---|
| D004553 | Electric Conductivity |
| D004560 | Electricity |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
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Bioelectrical impedance vector analysis
| Perioperative period (preoperatively, on the first, third, and fifth postoperative day) |
| 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 |
| 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 |
| D055585 |
| Physical Phenomena |