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Not yet recruiting NCT07034716

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

No phase Interventional Clinical Outcomes Cardiac Surgery Cardio-pulmonary Bypass

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CORONARY BYPASS SURGERY USING CARDIOPULMONARY BYPASS, cardiac surgical patients who will undergo isolated elective cardiopulmonary bypass.
Who it may be relevant to
Registry conditions: Clinical Outcomes, Cardiac Surgery, Cardio-pulmonary Bypass. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Procedure 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
  • 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

Primary outcome measures

  • effects of pulsatile versus non-pulsatile perfusion methods in CABG surgeries on arterial lactate level. [Time frame: 24 hour]
  • effects of pulsatile versus non-pulsatile perfusion methods in CABG surgeries on saturation of central venous blood. [Time frame: 24 hour]
Secondary outcome measures (3)
  • The duration of mechanical ventilation (hours). [Time frame: 24 hour]
  • Length of ICU stay (days) [Time frame: 24 hour]
  • Occurrence of major morbidity [Time frame: 72 hours]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07034716 · 0108887

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗