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

A

Alexandria University

Status

Not yet enrolling

Conditions

Cardiac Surgery
Cardio-pulmonary Bypass
Clinical Outcomes

Treatments

Procedure: cardiac surgical patients who will undergo isolated elective cardiopulmonary bypass
Procedure: CORONARY BYPASS SURGERY USING CARDIOPULMONARY BYPASS

Study type

Interventional

Funder types

Other

Identifiers

NCT07034716
0108887

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

60 participants in 2 patient groups

Group (P): Pulsatile flow will be used during CPB
Experimental group
Description:
Pulsatile flow will be used during CPB
Treatment:
Procedure: cardiac surgical patients who will undergo isolated elective cardiopulmonary bypass
Group NP: non-pulsatile perfusion.
Active Comparator group
Description:
non-pulsatile perfusion during CARDIOPULMONARY BYPASS
Treatment:
Procedure: CORONARY BYPASS SURGERY USING CARDIOPULMONARY BYPASS

Trial contacts and locations

0

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Central trial contact

islam elbardan, MD

Data sourced from clinicaltrials.gov

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