Cardiac Surgery, Cardio-pulmonary Bypass, Clinical Outcomes
Conditions
Keywords
Lactate, Perfusion, Central venous saturation
Brief summary
In cardiac operations, high values of blood lactate have been associated with bad outcomes if detected both during CPB and at the arrival in the intensive care unit (ICU) in adult patients. Many studies highlighted the potential role of hyperlactatemia on admission to the ICU as a marker for adverse outcome, and one study linked hyperlactatemia during CPB with postoperative morbidity and mortality. Evidence that both CENTRAL VENOUS SATURATION (ScVO2) and blood lactates during CPB are potential early predictors of morbidity and mortality in adult cardiac operations are still lacking.
Interventions
PROCEDURECORONARY BYPASS SURGERY USING CARDIOPULMONARY BYPASS
The study will be conducted on cardiac surgical patients who will undergo isolated elective CABG with nonpulsatile flow during cardiopulmonary bypass
PROCEDUREcardiac surgical patients who will undergo isolated elective cardiopulmonary bypass
The study will be conducted on cardiac surgical patients who will undergo isolated elective CABG with pulsatile flow during cardiopulmonary bypass
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
cardiac surgical patients who will undergo isolated elective CABG and fulfill these criteria: 1. Aged 18 years or above. 2. Operated with cardiopulmonary bypass.
Exclusion criteria
1. Preoperative lactate level greater than 3 mmol/l. 2. Redo surgery. 3. If the patient will be reoperated during the study time. 4. Preoperative hemoglobin level less than 10 mg/dl. 5. Ejection fraction (EF) of \<30%. 6. Renal impairment. 7. Liver impairment. 8. History of stroke and significant carotid artery stenosis. 9. Chronic obstructive or restrictive lung disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| effects of pulsatile versus non-pulsatile perfusion methods in CABG surgeries on saturation of central venous blood. | 24 hour | saturation of central venous blood (percentage) |
| effects of pulsatile versus non-pulsatile perfusion methods in CABG surgeries on arterial lactate level. | 24 hour | Arterila Lactate values (mmol/L). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The duration of mechanical ventilation (hours). | 24 hour | — |
| Length of ICU stay (days) | 24 hour | — |
| Occurrence of major morbidity | 72 hours | The occurrence of at least one in-hospital morbidity with or without in-hospital mortality. (Stroke, seizures, myocardial ischemia, low cardiac output state, post-perfusion syndrome, acute kidney injury, pancreatitis, acute hepatitis, and any other complication will be recorded |
Contacts
Primary Contactislam elbardan, MD
Outcome results
None listed