Recruiting

Observational StudyPrediction and Prevention of Postoperative Mortality and Morbidity

Sponsor:

University of Pittsburgh

Code:

NCT06042413

Conditions

Dementia

Postoperative Delirium (POD)

Postoperative Neurocognitive Disorder

Major Adverse Cardiac and Cerebrovascular Events

Perioperative Complications

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Personalized CPC Prehabilitation

Cognitive Training

Meditation

Daily Exercise

Enhanced Social Support

Study Details

Brief summary:

This study will contribute to creating a prospective and automated preoperative risk assessment algorithm for predicting 30-day mortality, major adverse cardiac and cerebrovascular events (MACCE), and postoperative neurocognitive outcomes following elective cardiac and vascular surgery in older adults. It will evaluate associations between perioperative factors and longer-term neurocognitive outcomes, including postoperative neurocognitive disorder and dementia. In addition, this study will assess scalable, multimodal preoperative and intraoperative interventions to improve perioperative outcomes.

This study will explore two main hypotheses:

1. Preoperative personalized prehabilitation with proactive cognitive and behavioral interventions will improve postoperative cognitive outcomes, morbidity, and mortality in high-risk elderly surgical patients.
2. Proactive bundled intraoperative interventions are superior to reactive standard of care in reducing postoperative cognitive outcomes, MACCE, and mortality.

Expected Outcome: Improved EHR algorithm will have higher predictive accuracy for MACCE and mortality while predicting postoperative cognitive outcomes.

Conditions

Dementia

Postoperative Delirium (POD)

Postoperative Neurocognitive Disorder

Major Adverse Cardiac and Cerebrovascular Events

Perioperative Complications

Study ID

NCT06042413

Start date

Oct 23, 2026

Status verified date

Jun, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Part I Inclusion Criteria:

65 years of age and older
Scheduled for major cardiac surgeries including coronary artery bypass and valvular repair and/or vascular surgeries including carotid endarterectomy, aortic aneurysm repair, and major vascular surgeries
Informed consent
English speaking patients

Part II Inclusion Criteria:

Enrolled in Aim 1 / Part I Preoperative Intervention Trial
Scheduled for high-risk, cardiac or vascular surgery requiring intraoperative neurophysiological monitoring (IONM)

Part I Exclusion Criteria:

Children (<18 years)
Patients unable to provide consent
Participants undergoing same day procedures or operations (discharged same day)
Patients with severe preoperative medical diseases such as blindness or significant visual impairment, unresolved motor weakness, or any other perioperative events or complications that would have a bearing on the patient's ability to perform study tasks, neuropsychological tests, and proposed interventions

Part II Exclusion Criteria:

Pregnant women
Patients do not provide consent.
Patients are unable to participate in cognitive and other behavioral assessment due to physical limitations
Patients refuse any blood transfusions during surgery

Study Design

Enrollment

1200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: CPC Preoperative Intervention (Aim 1)

Participants referred to the Center for Perioperative Care (CPC) by their surgical team will receive preoperative prehabilitation and proactive cognitive and behavioral interventions prior to surgery. Assignment to this group is not randomized and reflects real world clinical practice. Participants will receive standard intraoperative monitoring during surgery.

active comparator: Preoperative Standard of Care (Aim 1)

Participants who do not receive CPC referral will receive standard preoperative care prior to surgery. Assignment to this group is not randomized. Participants will receive standard intraoperative monitoring during surgery.

experimental: Proactive Bundled Intraoperative Interventions (Aim 2)

Participants in Aim 2 are drawn from Aim 1 participants who meet IONM eligibility. Participants requiring intraoperative neurophysiological monitoring will be randomized on the day of surgery to receive proactive bundled intraoperative interventions in addition to standard intraoperative monitoring.

active comparator: Reactive Intraoperative Standard of Care (Aim 2)

Participants in Aim 2 are drawn from Aim 1 participants who meet IONM eligibility. Participants requiring intraoperative neurophysiological monitoring will be randomized on the day of surgery to receive reactive standard of care intraoperative management with routine SSEP and EEG monitoring.

Interventions

Personalized CPC Prehabilitation

Patients referred for elective surgery will be scheduled for a preoperative evaluation (3 to 6 weeks prior to surgery) and will receive standardized and personalized assessment and prehabilitation according to UPMC disease specific algorithms

Cognitive Training

Participants will be provided with access to the Lumosity (Lumos Labs) software for installation on a home device. They will be trained to navigate the touchscreen tablet and guided through an introductory series of brain exercise games focused on 5 main categories: memory, speed, attention, flexibility, and problem-solving. Patients will be asked to complete a cognitive exercise dosage of a minimum of 20 minutes a day for ≥5 days prior to their date of surgery. Research coordinators and volunteers from UPMC's Hospital Elder Life Program (HELP) will reach out to participants daily for a quick social check-in and to remind them to perform their training. Compliance data will be retrieved from the Lumosity app.

Meditation

A single guided meditation session with instructions will be provided using a smart device. The meditation session will last for at least 10 minutes daily starting at least 1-week prior to surgery. If the subject does not own a smart device, one will be provided or meditation will be completed in-person or over the phone.

Daily Exercise

Participants in the intervention group will meet with an occupational or physical therapist approximately 1-6 weeks before surgery who will discuss the potential benefits of exercise and give directions for an easy strength training exercise. Participants will then be provided with a video link for a guided exercise and encouraged to walk or perform a seated strength exercise for ≥ 5 minutes each day for at least 1 week before surgery and after surgery. Patient reported frequency, fitness app compliance and exercise duration with REDCap email or mobile link or over telephone will be collected before and after surgery. Patients will be cleared by an occupational or physical therapist to perform the upper-extremity exercises and will confirm the exercises are not contraindicated after surgery. An occupational or physical therapist will see subject again post-surgery to mitigate risk of injury.

Enhanced Social Support

Research coordinators and volunteers from the Hospital Elder Life Program (HELP) will contact participants prior to surgery to discuss concerns, provide regular social support, and remind participants to complete assigned cognitive exercises. The role of family members and caregivers in supporting the participant will also be discussed, and their involvement will be encouraged when appropriate.

Participants in the CPC preoperative intervention group may receive preoperative interventions to address depressive symptoms as part of CPC-guided prehabilitation, when clinically indicated.

Proactive Bundle Interventions

Participants randomized to the proactive bundled intervention group (Group D) will receive routine intraoperative SSEP and EEG monitoring and proactive optimization of intraoperative physiology, including maintaining mean arterial pressure ≥65 mmHg, adequate oxygenation, opioid sparing analgesia, and avoidance of deep anesthesia and benzodiazepines.

If persistent focal changes in SSEP and EEG (i.e., changes in one hemisphere) occur, reactive measures will be implemented to increase cerebral perfusion, including ensuring hematocrit >30, maintaining anesthetic BIS >50-60, and initiating stroke management and thrombectomy if clinically indicated

Pre-operative Standard of Care

Participants will receive routine preoperative clinical care per institutional standard practice.

Intra-operative Standard of Care

This includes routine intraoperative SSEP and EEG monitoring. Physician oversight and interpretation of real-time neuromonitoring data will be performed using a combined on-site and remote model at UPMC. In the event that changes in EEG or SSEP are considered significant by the oversight neurophysiologists, the surgical team will be immediately informed so that immediate appropriate action can be taken to reverse the change.

Primary outcome measure

Postoperative Delirium (POD) [ Time Frame: At baseline screening, then up to 30 days post-operatively ]

Central Contacts and Locations

Central contacts

Alisha Maslanka, BS, CCRC

4128646779 maslankaaa@upmc.edu

Dayana Alsamsam, BSPS, MSc

412-623-4147 alsamsamd@upmc.edu

Locations

UPMC Montefiore Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Senthil Sadhasivam, MD

4126474484 sadhasivams@upmc.edu

UPMC Presbyterian Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Senthilkumar Sadhasivam

317-948-3845 ssadhasivam@IUHealth.org

Alisha Maslanka, BS, CCRC

412-864-6779 maslankaaa@upmc.edu

UPMC Shadyside Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Senthil Sadhasivam, MD

4126474484 sadhasivams@upmc.edu

UPMC Mercy Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15219

Contacts

Senthil Sadhasivam, MD

4126474484 sadhasivams@upmc.edu

UPMC Passavant Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15237

Contacts

Senthil Sadhasivam, MD

4126474484 sadhasivams@upmc.edu

More Information

Sponsor

University of Pittsburgh

Last update posted

Nov 12, 2026

Last verified

Jun, 2026

Keywords

MACCE
Cognitive decline
Perioperative brain health
Neurocognitive disorder
Postoperative delirium

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-13. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-11-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.