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

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.

The inclusion criteria to only include patients who consume alcoholic beverages was an IRB approved modification after already recruiting 1/3 of patients.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Complications; Alcohol Use Disorder
• Intervention / Treatment: Other: Blood Draw

• Study Type: Observational
• Enrollment (Estimated): 170

Contacts and Locations

• Study Contact: Name: Ayse Ulucay, MD; Phone Number: 216-844-3771; Email: Ayse.Ulucay@UHhospitals.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • University Hospital
      • Contact: Ayse Ulucay, MD; Phone Number: 216-844-3771; Email: Ayse.Ulucay@UHhospitals.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients undergoing elective surgery at UHCMC.

Description

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
• 4. Only patients who consume alcoholic beverages on a regular basis.

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients undergoing elective surgery at UHCMC.; Patients will have a single blood sample sent for PEth testing.	Other: Blood Draw; Patients will have a single blood sample sent for PEth testing, blood draws will happen during standard of care blood draw.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	Up to six months

Collaborators and Investigators

• Sponsor: University Hospitals Cleveland Medical Center
• Investigators: Principal Investigator: Salim Hayek, MD, PhD, University Hospitals

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: March 3, 2025
• First Submitted That Met QC Criteria: March 3, 2025
• First Posted (Actual): March 7, 2025

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 8, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: alcohol consumption; surgical outcomes
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Substance-Related Disorders; Chemically-Induced Disorders; Drinking Behavior; Alcohol-Related Disorders; Pathological Conditions, Signs and Symptoms; Behavior; Alcoholism; Alcohol Drinking; Postoperative Complications; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection
• Other Study ID Numbers: STUDY20240892

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No