Patient Undergoing CABG SurgeryNCT06839027
Arterial to Central co2gap in Relation to Outcome After Cardiopulmonary Bypass
An observational study of Patient Undergoing CABG Surgery and Ischemic Heart Disease Patients, run by Ain Shams University at 1 site in Egypt.
Trial summary
This trial aims to study the performance of CO2 gap, lactate level, and central venous oxygen saturation in predicting major postoperative complications after cardiac surgery with cardiopulmonary bypass Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Undergoing CABG Surgery, Ischemic Heart Disease Patients
- How many people
- 130 participants
- Where
- 1 siteEgypt
- Study dates
- 2 May 2026to 10 Sep 2026
- Phase
- Observational
- 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
Study population: Patients undergoing single cardiac surgery on bypass and post-operative in ICU for 7 days.
Who may be able to join
- • Patients undergoing elective cardiac surgery (Cardiopulmonary Bypass Grafting), with a maximum time on cardiopulmonary bypass of 120 minutes, will be screened for study eligibility.
- The inclusion criteria are:
- Age ≥ 18.
- Receive elective cardiac surgery (CABG) involving CPB with maximum time on CPB 120 mins.
- Admitted to ICU after the surgery.
- With an arterial line and a central venous catheter in place.
Who cannot join
- <!-- -->
- Unwilling to provide consent.
- Acute or chronic kidney disease before surgery
- Acute or chronic hepatic insufficiency before surgery.
- Malpositioning of the central venous catheter
- Pregnant.
- Patients with respiratory disorders such as COPD.
- Patients with a BMI more than or equal to 40.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Arterial to Central Venous co2 Gap in Relation to Outcome After Cardiopulmonary Bypass
This trial aims to study the performance of CO2 gap, lactate level, and central venous oxygen saturation in predicting major postoperative complications after cardiac surgery with cardiopulmonary bypass
Read the detailed description
Complications after cardiac surgery (e.g., acute respiratory failure, circulatory failure, acute kidney injury, neurological failure, etc.) are associated with high morbidity and mortality .
One crucial cause is the mismatch of oxygen delivery and consumption after the surgery, which is often the result of a decrease in cardiac output and/or an increase in oxygen demand due to stress . The imbalance of oxygen delivery and consumption leads to tissue hypoxia. Organ injury and dysfunction can occur if tissue hypoxia is not corrected. Timely identification and management of tissue hypoxia are essential to prevent the development of organ dysfunction and postoperative complications. Several biomarkers of hypoxia have been proposed to identify tissue hypoxia.
Markers of adequate tissue perfusion (lactate, ScVO2, and CO2 gap) have their limitations. Hyperlactatemia does not always reflect tissue dysoxia or anaerobic metabolism and can be aspecific (Schultz et al., 2006). Central venous oxygen saturation (ScVO2), used as a marker of dysoxia, can be normal despite microcirculatory impairment (Habicher et al., 2015). CO2 gaps can be used as a surrogate for the adequacy of cardiac output (CO) and as a marker for tissue perfusion and are therefore a potential target for resuscitation.
Current examinations are not satisfactory enough to answer the question of adequacy between oxygen supply and demand. Urine output, at its best, reflects the function of one organ only. The mixed venous oxygen saturation (SvO2) and the central venous oxygen saturation (ScvO2) reflect the oxygen exertion rate. However, they are often in a normal range or even in a supra-normal level in septic shock despite the presence of tissue anaerobic metabolism, partly due to microcirculatory shunting or the inability of the tissues to use oxygen (i.e., cytopathic hypoxia), or both . CO2-derived parameters overcome many of the limitations of the previous indices in indicating anaerobic tissue metabolism ,one can briefly interpret the concept as follows: the venous-arterial difference in CO2 partial pressure (Pv-aCO2 or PCO2 gap) is a useful index of the adequacy of cardiac output (CO) for the global metabolic conditions. In other words, a decrease in CO results in an increased PCO2 gap and vice versa. It can be measured as a venoarterial difference in PCO2 (PvCO2 - PaCO2).
CPB is a form of extracorporeal circulation whose function is to maintain circulation and respiratory support along with temperature management to facilitate operation on the heart and great vessels.
Components of the CPB machine include pumps, tubing, gas (oxygenator), and heat exchange units. Modern CPB machines are also equipped with monitoring systems that continuously monitor line or circuit pressure, temperature, and blood parameters (oxygen saturation, blood gases, hemoglobin [Hgb], potassium), as well as safety features such as air bubbles and fluid level detection systems and a blood filter in the arterial line .
CPB mechanically circulates and oxygenates blood for the body while bypassing the heart and lungs. The surgeon places a cannula in the right atrium, vena cava, or femoral vein to withdraw blood. Venous blood which is removed from the body by the venous cannula is filtered, cooled or warmed, oxygenated, and then returned to the body. The arterial cannula used to return oxygenated blood is usually inserted in the ascending aorta, but it may be inserted in the femoral artery. During the procedure, hypothermia may be maintained; body temperature is usually kept at 28 °C to 32 °C. The blood is cooled during CPB and returned to the body.
The PCO2 gap is the difference between the partial pressure of CO2 in venous blood (PvCO2) and arterial blood (PaCO2). PCO2 gap is considered to be a marker of the relationship between cardiac output (CO) to global metabolic demand, a marker of adequacy of venous blood flow to eliminate CO2 produced by peripheral tissues. Considering physiology, CO2 is the end product of aerobic metabolism and therefore venous CO2 content thus, PCO2 reflects the global tissue blood flow relative to metabolic demand. Under steady-state conditions, the PCO2 gap is determined by several factors: difference in veno-arterial CO2 content, CO2 dissociation curve (which expresses the relationship between CO2 pressure and CO2 content), CO, and alveolar ventilation. It has been shown that out of all these factors, a fall in CO has the maximum influence on the CO2 gap .
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| survival group and mortality group | patients will be categorized into two groups (mortality VS survival group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
7 days mortality
patients will be followed up for 7 days post operative
Measured: 7 days
Secondary outcomes (1)
1) Duration of mechanical ventilation. 2) Length of ICU stays. 3) Acute kidney injury (AKI). 4) Myocardial infarction. 5) Circulatory shock for any cause,
- Duration of mechanical ventilation.
- Length of ICU stays.
- Acute kidney injury (AKI).
- Myocardial infarction.
- Circulatory shock for any cause
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start2 May 2026 (estimated)
- Primary completion2 Sep 2026 (estimated)
- Study completion10 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient Undergoing CABG SurgeryStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marina emad fawzi hanna, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06839027
- Sponsor's protocol ID
- FMASU MD305/2024
- Status last verified
- Apr 2025
- First submitted
- 17 Feb 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arterial to Central Venous co2 Gap in Relation to Outcome After Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT06839027
- Acronym / sponsor ID
- FMASU MD305/2024
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 2 May 2026 (estimated)
- Primary completion
- 2 Sep 2026 (estimated)
- Study completion
- 10 Sep 2026 (estimated)
- First posted
- 21 Feb 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.
This trial aims to study the performance of CO2 gap, lactate level, and central venous oxygen saturation in predicting major postoperative complications after cardiac surgery with cardiopulmonary bypass
Detailed description
Complications after cardiac surgery (e.g., acute respiratory failure, circulatory failure, acute kidney injury, neurological failure, etc.) are associated with high morbidity and mortality .
One crucial cause is the mismatch of oxygen delivery and consumption after the surgery, which is often the result of a decrease in cardiac output and/or an increase in oxygen demand due to stress . The imbalance of oxygen delivery and consumption leads to tissue hypoxia. Organ injury and dysfunction can occur if tissue hypoxia is not corrected. Timely identification and management of tissue hypoxia are essential to prevent the development of organ dysfunction and postoperative complications. Several biomarkers of hypoxia have been proposed to identify tissue hypoxia.
Markers of adequate tissue perfusion (lactate, ScVO2, and CO2 gap) have their limitations. Hyperlactatemia does not always reflect tissue dysoxia or anaerobic metabolism and can be aspecific (Schultz et al., 2006). Central venous oxygen saturation (ScVO2), used as a marker of dysoxia, can be normal despite microcirculatory impairment (Habicher et al., 2015). CO2 gaps can be used as a surrogate for the adequacy of cardiac output (CO) and as a marker for tissue perfusion and are therefore a potential target for resuscitation.
Current examinations are not satisfactory enough to answer the question of adequacy between oxygen supply and demand. Urine output, at its best, reflects the function of one organ only. The mixed venous oxygen saturation (SvO2) and the central venous oxygen saturation (ScvO2) reflect the oxygen exertion rate. However, they are often in a normal range or even in a supra-normal level in septic shock despite the presence of tissue anaerobic metabolism, partly due to microcirculatory shunting or the inability of the tissues to use oxygen (i.e., cytopathic hypoxia), or both . CO2-derived parameters overcome many of the limitations of the previous indices in indicating anaerobic tissue metabolism ,one can briefly interpret the concept as follows: the venous-arterial difference in CO2 partial pressure (Pv-aCO2 or PCO2 gap) is a useful index of the adequacy of cardiac output (CO) for the global metabolic conditions. In other words, a decrease in CO results in an increased PCO2 gap and vice versa. It can be measured as a venoarterial difference in PCO2 (PvCO2 - PaCO2).
CPB is a form of extracorporeal circulation whose function is to maintain circulation and respiratory support along with temperature management to facilitate operation on the heart and great vessels.
Components of the CPB machine include pumps, tubing, gas (oxygenator), and heat exchange units. Modern CPB machines are also equipped with monitoring systems that continuously monitor line or circuit pressure, temperature, and blood parameters (oxygen saturation, blood gases, hemoglobin [Hgb], potassium), as well as safety features such as air bubbles and fluid level detection systems and a blood filter in the arterial line .
CPB mechanically circulates and oxygenates blood for the body while bypassing the heart and lungs. The surgeon places a cannula in the right atrium, vena cava, or femoral vein to withdraw blood. Venous blood which is removed from the body by the venous cannula is filtered, cooled or warmed, oxygenated, and then returned to the body. The arterial cannula used to return oxygenated blood is usually inserted in the ascending aorta, but it may be inserted in the femoral artery. During the procedure, hypothermia may be maintained; body temperature is usually kept at 28 °C to 32 °C. The blood is cooled during CPB and returned to the body.
The PCO2 gap is the difference between the partial pressure of CO2 in venous blood (PvCO2) and arterial blood (PaCO2). PCO2 gap is considered to be a marker of the relationship between cardiac output (CO) to global metabolic demand, a marker of adequacy of venous blood flow to eliminate CO2 produced by peripheral tissues. Considering physiology, CO2 is the end product of aerobic metabolism and therefore venous CO2 content thus, PCO2 reflects the global tissue blood flow relative to metabolic demand. Under steady-state conditions, the PCO2 gap is determined by several factors: difference in veno-arterial CO2 content, CO2 dissociation curve (which expresses the relationship between CO2 pressure and CO2 content), CO, and alveolar ventilation. It has been shown that out of all these factors, a fall in CO has the maximum influence on the CO2 gap .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| survival group and mortality group | – | –patients will be categorized into two groups (mortality VS survival group) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing single cardiac surgery on bypass and post-operative in ICU for 7 days.
Key inclusion criteria (6 listed)
- • Patients undergoing elective cardiac surgery (Cardiopulmonary Bypass Grafting), with a maximum time on cardiopulmonary bypass of 120 minutes, will be screened for study eligibility.
Key exclusion criteria (8 listed)
- <!-- -->
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
7 days mortality
Time frame: 7 days
patients will be followed up for 7 days post operative
1 secondary outcome
1) Duration of mechanical ventilation. 2) Length of ICU stays. 3) Acute kidney injury (AKI). 4) Myocardial infarction. 5) Circulatory shock for any cause,
Time frame: 7 days
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 1 Oct 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Undergoing CABG Surgery and Ischemic Heart Disease Patients, run by Ain Shams University at 1 site in Egypt.
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 6 inclusion and 8 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 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 marina emad fawzi, masters degree in anathesia (01277438348, marina.hanna@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7 days mortality (time frame: 7 days). 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 1 Oct 2025.