Recruiting

Observational Study

Sponsor:

University Hospitals Cleveland Medical Center

Code:

NCT06864819

Conditions

Postoperative Complications

Alcohol Use Disorder

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

Blood Draw

Study Details

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

Study ID

NCT06864819

Start date

May 5, 2025

Status verified date

Sep, 2026

Completion date

Nov 15, 2026

Anticipated

Primary completion date

Nov 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

170 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients undergoing elective surgery at UHCMC.

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

Interventions

Blood Draw

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

Primary outcome measure

  • Phosphatidylethanol level as measured by blood draw. [ Time Frame: Baseline ]
  • Length of ICU stay measured in days [ Time Frame: Up to 7 days ]
  • Length of hospital stay measured in days [ Time Frame: Up to 2 weeks ]
  • Number of perioperative complications as measured by medical record review. [ Time Frame: Up to six months ]

Central Contacts and Locations

Central contacts

Locations

University Hospital

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

More Information

Sponsor

University Hospitals Cleveland Medical Center

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Keywords

  • alcohol consumption
  • surgical outcomes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Hospitals Cleveland Medical Center on 2026-09-04.