Prediction and Prevention of Postoperative Mortality and Morbidity
Key facts
- Who runs it
- University of Pittsburgh
- Where
- Pittsburgh, United StatesSee the 5 sites
- Trial code
- Status
- Recruiting
- People taking part
- 1,200 people, planned
- Started
- 23 Oct 2026
- Expected to end
- Dec 2027
- Type of study
- Interventional, 4 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Personalized CPC Prehabilitation
- Cognitive Training
- Meditation
- Daily Exercise
- Enhanced Social Support
- Proactive Bundle Interventions
- Pre-operative Standard of Care
- Intra-operative Standard of Care
- Record updated
- 12 November 2026
Who can take part
- Age
- 65 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 15 criteriaShow less
Other criteria
- 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
Where in United States
- UPMC Montefiore HospitalPittsburgh, United StatesContact: Senthil Sadhasivam, MDTaking people
- UPMC Presbyterian HospitalPittsburgh, United StatesContact: Senthilkumar SadhasivamTaking people
- UPMC-Mercy HospitalPittsburgh, United StatesContact: Senthil Sadhasivam, MDTaking people
- UPMC-Passavant HospitalPittsburgh, United StatesContact: Senthil Sadhasivam, MDTaking people
- UPMC-Shadyside HospitalPittsburgh, United StatesContact: Senthil Sadhasivam, MDTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 4 groups in the trial
- CPC Preoperative Intervention (Aim 1)Treatment being tested
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.
Treatment: Personalized CPC Prehabilitation, Cognitive Training, Meditation, Daily Exercise, Enhanced Social Support, and Intra-operative Standard of Care
- Preoperative Standard of Care (Aim 1)Existing treatment, for comparison
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.
Treatment: Pre-operative Standard of Care and Intra-operative Standard of Care
- Proactive Bundled Intraoperative Interventions (Aim 2)Treatment being tested
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.
Treatment: Proactive Bundle Interventions and Intra-operative Standard of Care
- Reactive Intraoperative Standard of Care (Aim 2)Existing treatment, for comparison
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.
Treatment: Intra-operative Standard of Care
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Real-world and Innovative Multimodal Prediction and Prevention of Postoperative Mortality and Multi-morbidities
- Record updated
- 12 November 2026