Role of Phosphatidylethanol in Predicting Perioperative Outcomes of Admitted Patients at UHCMC

Recruiting

• Conditions: Postoperative Complications; Alcohol Use Disorder

• Registration Number: NCT06864819
• Lead Sponsor: University Hospitals Cleveland Medical Center

Brief Summary

This study aims to see if there's a link between a substance called phosphatidylethanol (PEth) and how patients who have surgery at University Hospitals do after surgery. PEth levels reflect the amount of alcohol use by someone over the past few weeks. This study is checking PEth levels on all patients who are planned to stay in the hospital for three or more days after surgery regardless if they drink alcohol. Specifically, it will look at if PEth levels are connected to problems that might come up during and after surgery, like confusion, lung or heart issues, needing blood transfusions, infections, unexpected intensive care unit (ICU) stays, and longer hospital stays. While there are reports of moderate alcohol consumption being good for the heart, there are other data that alcohol consumption can be harmful. Since there's not much information on how drinking alcohol affects health outcomes during and after surgery, especially for patients who are planned to be admitted to the hospital ward or ICU after surgery, this study will hopefully see if PEth levels before surgery can predict how patients do after the surgery.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-03
• Study First Submitted QC: 2025-03-03
• Study First Posted: 2025-03-07
• Status Verified: 2025-05
• Study Start: 2025-05-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-08
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

• 1. Age range: 21-79
• 2. Patients undergoing elective surgery at UHCMC with planned ICU admission
• 3. Patients undergoing elective surgery at UHCMC with expected in-hospital admission for three or more days

Exclusion Criteria

• 1. Patients undergoing same day outpatient surgeries or expected to be admitted less than three days post-operatively
• 2. Subjects who have received a blood transfusion within the past month before surgery
• 3. Pregnant subjects

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Phosphatidylethanol level as measured by blood draw.	Baseline
Length of ICU stay measured in days	Up to 7 days
Length of hospital stay measured in days	Up to 2 weeks
Number of perioperative complications as measured by medical record review.	Up to six months	Perioperative complications including but not limited to delirium, pulmonary complications, cardiovascular complications, need for transfusion including amount transfused, post-operative infections, unexpected admission to the intensive care unit (ICU) and increased length of stay

Trial Locations

Locations (1)

University Hospital; 🇺🇸 Cleveland, Ohio, United States