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

NCT07034716 | Not Yet Recruiting

• 1 other identifier: 0108887
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Clinical Outcomes; Cardiac Surgery; Cardio-pulmonary Bypass

Keywords

Lactate; Perfusion; Central venous saturation

Outcome Measures

Primary Outcomes (2)

• effects of pulsatile versus non-pulsatile perfusion methods in CABG surgeries on arterial lactate level.

  Arterila Lactate values (mmol/L).

  24 hour

• effects of pulsatile versus non-pulsatile perfusion methods in CABG surgeries on saturation of central venous blood.

  saturation of central venous blood (percentage)

  24 hour

Secondary Outcomes (3)

• The duration of mechanical ventilation (hours).

  24 hour

• Length of ICU stay (days)

  24 hour

• Occurrence of major morbidity

  72 hours

Study Arms (2)

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

EXPERIMENTAL

Pulsatile flow will be used during CPB

Procedure: cardiac surgical patients who will undergo isolated elective cardiopulmonary bypass

Group NP: non-pulsatile perfusion.

ACTIVE COMPARATOR

non-pulsatile perfusion during CARDIOPULMONARY BYPASS

Procedure: CORONARY BYPASS SURGERY USING CARDIOPULMONARY BYPASS

Interventions

CORONARY BYPASS SURGERY USING CARDIOPULMONARY BYPASS PROCEDURE

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

Group NP: non-pulsatile perfusion.

cardiac surgical patients who will undergo isolated elective cardiopulmonary bypass PROCEDURE

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• cardiac surgical patients who will undergo isolated elective CABG and fulfill these criteria:
• Aged 18 years or above.
• Operated with cardiopulmonary bypass.

You may not qualify if:

• Preoperative lactate level greater than 3 mmol/l.
• Redo surgery.
• If the patient will be reoperated during the study time.
• Preoperative hemoglobin level less than 10 mg/dl.
• Ejection fraction (EF) of \<30%.
• Renal impairment.
• Liver impairment.
• History of stroke and significant carotid artery stenosis.
• Chronic obstructive or restrictive lung disease.

Sponsors & Collaborators

• Alexandria University: lead

Study Officials

• LECTURER OF ANESTHESIA AND SURGICAL INTENSIVE CARE

  University of Alexandria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

islam elbardan, MD

CONTACT

+201112278083; Islam.elbardan@Alexmed.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecture of anesthesia and surgical intensive care

Study Record Dates

• First Submitted: June 8, 2025
• First Posted: June 24, 2025
• Study Start: July 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 24, 2025

Record last verified: 2025-06