Predictors Of Outcome After Coronary Artery Bypass Graft Surgery Using Cardiopulmonary Bypass

Not Applicable

Not yet recruiting

• Conditions: Clinical Outcomes; Cardiac Surgery; Cardio-pulmonary Bypass

• Registration Number: NCT07034716
• Lead Sponsor: Alexandria University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-08
• Study First Submitted QC: 2025-06-14
• Last Update Submitted: 2025-06-14
• Study First Posted: 2025-06-24
• Last Update Posted: 2025-06-24
• Study Start: 2025-07-01
• Primary Completion: 2025-11-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
effects of pulsatile versus non-pulsatile perfusion methods in CABG surgeries on arterial lactate level.	24 hour	Arterila Lactate values (mmol/L).
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)

Secondary Outcome Measures

Name	Time	Method
The duration of mechanical ventilation (hours).	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
Length of ICU stay (days)	24 hour