An observational study in Postoperative Cognitive Dysfunction (POCD), Cardiac Surgery and Cardiopulmonary Bypass, sponsored by Ain Shams University. Not yet recruiting. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Ain Shams University · Observational
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).
This prospective observational cohort study will be conducted at El-Demerdash Hospital, Ain Shams University. Patients aged 65 years and older undergoing elective cardiac surgery with cardiopulmonary bypass will be enrolled. Serial measurements of the PCO₂ gap and arterial lactate will be obtained before induction, during CPB, at the end of CPB, 30 minutes after weaning from CPB, and immediately postoperatively. Cognitive function will be evaluated preoperatively and one month after surgery using the Montreal Cognitive Assessment (MoCA). Postoperative delirium will be assessed daily during ICU stay using CAM-ICU. The study will investigate the predictive value of intraoperative PCO₂ gap and lactate levels for postoperative cognitive dysfunction and determine potential cutoff values associated with cognitive decline.
260 studies on the registry are indexed under Postoperative Cognitive Complications; 55 are open to participants now.
This study's planned enrollment of 185 is above the median of 100 across 113 observational studies indexed under Postoperative Cognitive Complications.
Browse Postoperative Cognitive Complications studies →Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients aged 65 years or older undergoing elective cardiac surgery with cardiopulmonary bypass. Participants will undergo serial intraoperative measurements of the venous-to-arterial carbon dioxide partial pressure difference (PCO₂ gap) and arterial lactate levels. Postoperative cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA), and postoperative delirium will be screened using the Confusion Assessment Method for the ICU (CAM-ICU).
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 postoperatively
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 first
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 postoperative
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 postoperatively
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 postoperatively
Duration of Mechanical Ventilation in Relation to Intraoperative PCO₂ Gap and Arterial Lactate Levels
To evaluate the association between intraoperative PCO₂ gap and arterial lactate levels and the duration of mechanical ventilation following cardiac surgery with cardiopulmonary bypass. Duration of mechanical ventilation will be measured in hours from the end of surgery until successful extubation, as documented in the patient's medical and ventilator records.
Time frame: Measured from the end of surgery until successful extubation (up to 30 days)
Duration of Intensive Care Unit Stay in Relation to Intraoperative PCO₂ Gap and Arterial Lactate Levels
To evaluate the association between intraoperative PCO₂ gap and arterial lactate levels and the duration of intensive care unit (ICU) stay following cardiac surgery with cardiopulmonary bypass. ICU stay will be measured in days from ICU admission after surgery until ICU discharge, as documented in the patient's medical records.
Time frame: From ICU admission after surgery until ICU discharge, up to 30 days
Duration of Hospital Stay in Relation to Intraoperative PCO₂ Gap and Arterial Lactate Levels
To evaluate the association between intraoperative PCO₂ gap and arterial lactate levels and the duration of hospital stay following cardiac surgery with cardiopulmonary bypass. Hospital stay will be measured in days from the end of surgery until hospital discharge, as documented in the patient's medical records.
Time frame: From the end of surgery until hospital discharge, up to 30 days
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for May 2028, 17 months later.
Of 76 non-industry observational studies under Postoperative Cognitive Complications, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 65. This study's planned 17 months is below that.
Counting every sponsor, half of 76 studies reached it within 27 months; a quarter within 11 and three quarters within 65.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Postoperative Cognitive Complications →