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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06864819
Enrollment
170
Registered
2025-03-07
Start date
2025-05-05
Completion date
2026-11-15
Last updated
2026-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Use Disorder, Postoperative Complications

Keywords

alcohol consumption, surgical outcomes

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.

Interventions

OTHERBlood Draw

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

Sponsors

University Hospitals Cleveland Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
21 Years to 79 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Phosphatidylethanol level as measured by blood draw.Baseline
Length of ICU stay measured in daysUp to 7 days
Length of hospital stay measured in daysUp to 2 weeks
Number of perioperative complications as measured by medical record review.Up to six monthsPerioperative 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

Countries

United States

Contacts

CONTACTAyse Ulucay, MD
ayse.ulucay@uhhospitals.org216-844-3771
PRINCIPAL_INVESTIGATORSalim Hayek, MD, PhD

University Hospitals

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 5, 2026