Clinical OutcomesNCT07034716
Predictors Of Outcome After Coronary Artery Bypass Graft Surgery Using Cardiopulmonary Bypass
A study testing CORONARY BYPASS SURGERY USING CARDIOPULMONARY BYPASS and cardiac surgical patients who will undergo isolated elective cardiopulmonary bypass in people with Clinical Outcomes and Cardiac Surgery, run by Alexandria University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clinical Outcomes, Cardiac Surgery, Cardio-pulmonary Bypass
- What is being tested?
- CORONARY BYPASS SURGERY USING CARDIOPULMONARY BYPASS and cardiac surgical patients who will undergo isolated elective cardiopulmonary bypass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- cardiac surgical patients who will undergo isolated elective CABG and fulfill these criteria:
- Aged 18 years or above.
- Operated with cardiopulmonary bypass.
Who cannot join
- 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.
Show all 9Show fewer
- Liver impairment.
- History of stroke and significant carotid artery stenosis.
- Chronic obstructive or restrictive lung disease.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects Of Pulsatile and Non-Pulsatile Cardiopulmonary Bypass Flow On Predictors Of Outcome After Coronary Artery Bypass Graft Surgery
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
- Being tested
- CORONARY BYPASS SURGERY USING CARDIOPULMONARY BYPASS, cardiac surgical patients who will undergo isolated elective cardiopulmonary bypass
- Keywords
- Lactate, Perfusion, Central venous saturation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CORONARY BYPASS SURGERY USING CARDIOPULMONARY BYPASSProcedure or surgery
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 bypassProcedure or surgery
The study will be conducted on cardiac surgical patients who will undergo isolated elective CABG with pulsatile flow during cardiopulmonary bypass
| Study group | Role | What they receive |
|---|---|---|
| Group (P): Pulsatile flow will be used during CPB | Experimental | Pulsatile flow will be used during CPB Receives: Procedure: cardiac surgical patients who will undergo isolated elective cardiopulmonary bypass |
| Group NP: non-pulsatile perfusion. | Active comparator | non-pulsatile perfusion during CARDIOPULMONARY BYPASS Receives: Procedure: CORONARY BYPASS SURGERY USING CARDIOPULMONARY BYPASS |
What is being measured
The primary outcome is the main question the study is designed to answer.
effects of pulsatile versus non-pulsatile perfusion methods in CABG surgeries on arterial lactate level.
Arterila Lactate values (mmol/L).
Measured: 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)
Measured: 24 hour
Secondary outcomes (3)
The duration of mechanical ventilation (hours).
Measured: 24 hour
Length of ICU stay (days)
Measured: 24 hour
Occurrence of major morbidity
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
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical OutcomesStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Elbardan, Alexandria University
- Investigators
- LECTURER OF ANESTHESIA AND SURGICAL INTENSIVE CARE, Principal investigator, University of Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07034716
- Sponsor's protocol ID
- 0108887
- Status last verified
- Jun 2025
- First submitted
- 8 Jun 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Pulsatile and Non-Pulsatile Cardiopulmonary Bypass Flow On Predictors Of Outcome After Coronary Artery Bypass Graft Surgery
- ClinicalTrials.gov ID
- NCT07034716
- Acronym / sponsor ID
- 0108887
- Conditions
- Clinical Outcomes, Cardiac Surgery, Cardio-pulmonary Bypass
- Keywords
- Lactate, Perfusion, Central venous saturation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (P): Pulsatile flow will be used during CPB | Experimental | Procedure: cardiac surgical patients who will undergo isolated elective cardiopulmonary bypassPulsatile flow will be used during CPB |
| Group NP: non-pulsatile perfusion. | Active comparator | Procedure: CORONARY BYPASS SURGERY USING CARDIOPULMONARY BYPASSnon-pulsatile perfusion during CARDIOPULMONARY BYPASS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- cardiac surgical patients who will undergo isolated elective CABG and fulfill these criteria:
- Aged 18 years or above.
- Operated with cardiopulmonary bypass.
Key exclusion criteria (9 listed)
- 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%.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CORONARY BYPASS SURGERY USING CARDIOPULMONARY BYPASSThe study will be conducted on cardiac surgical patients who will undergo isolated elective CABG with nonpulsatile flow during cardiopulmonary bypass | Procedure or surgery | Group NP: non-pulsatile perfusion. |
| cardiac surgical patients who will undergo isolated elective cardiopulmonary bypassThe study will be conducted on cardiac surgical patients who will undergo isolated elective CABG with pulsatile flow during cardiopulmonary bypass | Procedure or surgery | Group (P): Pulsatile flow will be used during CPB |
Primary outcome
effects of pulsatile versus non-pulsatile perfusion methods in CABG surgeries on arterial lactate level.
Time frame: 24 hour
Arterila Lactate values (mmol/L).
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)
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
LECTURER OF ANESTHESIA AND SURGICAL INTENSIVE CARE principal investigator
University of Alexandria
Questions about this trial
What is this clinical trial studying?
A study testing CORONARY BYPASS SURGERY USING CARDIOPULMONARY BYPASS and cardiac surgical patients who will undergo isolated elective cardiopulmonary bypass in people with Clinical Outcomes and Cardiac Surgery, run by Alexandria University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact islam elbardan, MD (+201112278083, Islam.elbardan@Alexmed.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effects of pulsatile versus non-pulsatile perfusion methods in CABG surgeries on arterial lactate level. (time frame: 24 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.