PCO₂ Gap and Lactate as Predictors of POCD After Cardiac Surgery
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorAin Shams University
About this trial
This prospective observational study aims to evaluate whether intraoperative venous-to-arterial carbon dioxide partial pressure difference (PCO₂ gap) and arterial lactate levels can serve as early predictors of postoperative cognitive dysfunction (POCD) in elderly patients undergoing elective cardiac surgery with cardiopulmonary bypass. Intraoperative measurements of PCO₂ gap and lactate will be correlated with perioperative cognitive outcomes assessed using the Montreal Cognitive Assessment (MoCA) and postoperative delirium screening using the Confusion Assessment Method for the ICU (CAM-ICU).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥65 years.
Undergoing elective cardiac surgery with cardiopulmonary bypass (e.g., coronary artery bypass grafting or valve surgery).
American Society of Anesthesiologists (ASA) Physical Status III.
Able to provide written informed consent.
Disqualifiers
Refusal or inability to provide written informed consent.
Pre-existing neurological disorders (e.g., Alzheimer's disease, Parkinson's disease, or stroke with residual neurological deficits).
Severe psychiatric disorders requiring active treatment.
History of drug or alcohol abuse.
Trial population
Elderly patients (65 years or older) undergoing elective cardiac surgery with cardiopulmonary bypass at El-Demerdash Hospital, Ain Shams University, Cairo, Egypt. Eligible participants will undergo routine perioperative management with serial intraoperative PCO₂ gap and arterial lactate measurements and perioperative cognitive assessment according to the study protocol.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
185 Participants
are grouped into 1 trial groupGroup A: Elderly Patients Undergoing Elective Cardiac Surgery with Cardiopulmonary Bypass
Trial outcomes
Primary outcomes
1
Predictive Value of Intraoperative PCO₂ Gap and Arterial Lactate Levels for Postoperative Cognitive Dysfunction (POCD
To evaluate whether intraoperative venous-to-arterial carbon dioxide partial pressure difference (PCO₂ gap) and arterial lactate levels predict postoperative cognitive dysfunction in elderly patients undergoing elective cardiac surgery with cardiopulmonary bypass. POCD will be assessed by changes in Montreal Cognitive Assessment (MoCA) scores from the preoperative baseline to 1 month postoperatively.
Time frame
Baseline (preoperative) and 1 month postoperativelySecondary outcomes
1
Early Postoperative Delirium Assessed by the Confusion Assessment Method for the ICU (CAM-ICU)
To determine the occurrence of early postoperative delirium using the Confusion Assessment Method for the ICU (CAM-ICU). CAM-ICU is a dichotomous assessment (positive or negative), where a positive result indicates the presence of delirium
Time frame
Daily during the first 5 postoperative days or until ICU discharge, whichever occurs first2
Determination of Cutoff Values for Intraoperative PCO₂ Gap and Arterial Lactate Levels Predictive of POCD
To identify optimal cutoff values for intraoperative PCO₂ gap and arterial lactate levels associated with postoperative cognitive dysfunction in elderly patients undergoing cardiac surgery with cardiopulmonary bypass.The PCO₂ gap will be measured in mmHg, and arterial lactate concentration will be measured in mmol/L.
Time frame
1 month postoperative3
Correlation of (CAM - ICU) to MoCA for prediction of cognitive impairmentat 5 days post operative
To evaluate the correlation between postoperative delirium assessed by the Confusion Assessment Method for the ICU (CAM-ICU) and postoperative cognitive function assessed by the Montreal Cognitive Assessment (MoCA).CAM-ICU will be recorded as a dichotomous result (positive or negative), with a positive result indicating the presence of delirium. MoCA will be recorded as a total score ranging from 0 to 30, with higher scores indicating better cognitive function
Time frame
CAM-ICU: Daily during the first 5 postoperative days; MoCA: baseline preoperatively and 1 month postoperatively4
Incidence of POCD at 1 month postoperatively, defined by a decline in MoCA scores from baseline in elderly cardiac patient.
To determine the incidence of postoperative cognitive dysfunction, defined as a decline in MoCA score from the preoperative baseline, one month after cardiac surgery
Time frame
Baseline (preoperative) and 1 month postoperativelyLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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