Prediction and Prevention of Postoperative Mortality and Morbidity

Launched by UNIVERSITY OF PITTSBURGH · Sep 13, 2023

Keywords

ClinConnect Summary

This clinical trial is focused on improving the health and safety of older adults who are facing major surgeries, particularly those with Alzheimer’s Disease (AD) or related conditions. The study aims to develop a new system that can better predict risks like death or serious complications after surgery. Researchers will explore whether special pre-surgery programs—designed to enhance physical and mental health—can lead to better outcomes after surgery, compared to the usual care patients receive.

To participate in this trial, individuals need to be at least 65 years old and considered at higher risk for complications based on specific health indicators. They should be scheduled for certain major surgeries, like heart or vascular procedures. Participants will be required to give their consent and will need to speak English. Throughout the study, they can expect to receive tailored support aimed at improving their overall wellbeing before and after surgery. It's important to note that the trial is not yet recruiting participants, so further details will be provided when it begins.

Gender

ALL

Eligibility criteria

• Part I Inclusion Criteria:
• • 65 years of age and older
• • Identified as higher risk (≥2.5%) for 30-day mortality and MACCE based on the UPMC's Perioperative Model (EHR risk prediction algorithm)
• • 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
• • RAI score ≥ 30
• • PHQ-9 score ≥ 5
• • Anticipated length of stay \> 3 days
• • Informed consent
• • English speaking patients
• • All races and ethnicities
• • Diverse background (education, area deprivation index)
• Part II Inclusion Criteria:
• • Patients undergoing high-risk cardiac and vascular surgery, such as intraoperative bypass for cardiac surgeries and carotid endarterectomy/ aortic aneurysm vascular surgeries.
• • History of fully resolved stroke and TIA without any residual weakness
• • Significant carotid artery stenosis (defined as \>70% unilateral or bilateral stenosis)
• • Moderate and high risk for mortality based on Society of Thoracic Surgery score (score \>4)
• • Enrolled in Part 1, "Randomized controlled clinical trial to assess the effectiveness of preoperative personalized prehabilitation as well as cognitive and behavioral interventions on reducing postoperative delirium (POD), postoperative cognitive dysfunction (POCD), dementia, 30-day major adverse cardiac and cerebrovascular events (MACCE) and mortality in high-risk surgical patients (≥65y)."
• Part I Exclusion Criteria:
• • Children (\<18 years)
• • Patients unable to provide consent
• • MoCA score \<23
• • Persistent weakness from prior cerebrovascular accident
• • Patients with severe preoperative medical diseases, blindness or significant visual impairment, unresolved motor weakness, or any other perioperative events or complications that would have a bearing on the patients' 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