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

NCT06864819 | Recruiting DMC

• 1 other identifier: STUDY20240892
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

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

Conditions

Postoperative Complications; Alcohol Use Disorder

Keywords

alcohol consumption; surgical outcomes

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Patients undergoing elective surgery at UHCMC.

Patients will have a single blood sample sent for PEth testing.

Other: Blood Draw

Interventions

Blood Draw OTHER

Patients will have a single blood sample sent for PEth testing, blood draws will happen during standard of care blood draw.

Patients undergoing elective surgery at UHCMC.

Eligibility Criteria

• Age: 21 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing elective surgery at UHCMC.

You may qualify if:

• \. Age range: 21-79
• \. Patients undergoing elective surgery at UHCMC with planned ICU admission
• \. Patients undergoing elective surgery at UHCMC with expected in-hospital admission for three or more days
• \. Only patients who consume alcoholic beverages on a regular basis.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospital

Cleveland, Ohio, 44106, United States

RECRUITING

MeSH Terms

Conditions

Postoperative Complications; Alcoholism; Alcohol Drinking

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Salim Hayek, MD, PhD

  University Hospitals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayse Ulucay, MD

CONTACT

216-844-3771; ayse.ulucay@uhhospitals.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Vice Chair for Clinical Research, Department of Anesthesiology

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 7, 2025
• Study Start: May 5, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)