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

NCT ID: NCT07034716

Last Updated: 2025-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2025-12-01

Brief Summary

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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

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Conditions

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Clinical Outcomes Cardiac Surgery Cardio-pulmonary Bypass

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group (P): Pulsatile flow will be used during CPB

Pulsatile flow will be used during CPB

Group Type EXPERIMENTAL

cardiac surgical patients who will undergo isolated elective cardiopulmonary bypass

Intervention Type PROCEDURE

The study will be conducted on cardiac surgical patients who will undergo isolated elective CABG with pulsatile flow during cardiopulmonary bypass

Group NP: non-pulsatile perfusion.

non-pulsatile perfusion during CARDIOPULMONARY BYPASS

Group Type ACTIVE_COMPARATOR

CORONARY BYPASS SURGERY USING CARDIOPULMONARY BYPASS

Intervention Type PROCEDURE

The study will be conducted on cardiac surgical patients who will undergo isolated elective CABG with nonpulsatile flow during cardiopulmonary bypass

Interventions

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CORONARY 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

Intervention Type PROCEDURE

cardiac 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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Islam Elbardan

Lecture of anesthesia and surgical intensive care

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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LECTURER OF ANESTHESIA AND SURGICAL INTENSIVE CARE

Role: PRINCIPAL_INVESTIGATOR

University of Alexandria

Central Contacts

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islam elbardan, MD

Role: CONTACT

+201112278083

Other Identifiers

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0108887

Identifier Type: -

Identifier Source: org_study_id

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