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NCT Number: NCT07034716

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

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.

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Key information

Conditions

Clinical Outcomes Cardiac Surgery Cardio-pulmonary Bypass

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

cardiac surgical patients who will undergo isolated elective CABG and fulfill these criteria:

  • Aged 18 years or above.
  • Operated with cardiopulmonary bypass.

Exclusion criteria

  • 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.

Treatment and study plan

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

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

Primary outcomes

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

    Time frame: 24 hour

    Arterila Lactate values (mmol/L).

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

    Time frame: 24 hour

    saturation of central venous blood (percentage)

Secondary outcomes

  1. The duration of mechanical ventilation (hours).

    Time frame: 24 hour

  2. Length of ICU stay (days)

    Time frame: 24 hour

  3. Occurrence of major morbidity

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

islam elbardan, MD

CONTACT

[email protected]

+201112278083

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Effects Of Pulsatile and Non-Pulsatile Cardiopulmonary Bypass Flow On Predictors Of Outcome After Coronary Artery Bypass Graft Surgery

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 24, 2025
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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