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NCT Number: NCT06864819

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.

Recruiting

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Key information

Conditions

Postoperative Complications Alcohol Drinking Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Behavior Chemically-Induced Disorders Drinking Behavior Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Substance-Related Disorders

Age range

21 year–79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital

Cleveland, Ohio, 44106, United States

Location status: Recruiting

Location contact

Ayse Ulucay, MD

CONTACT

[email protected]

216-844-3771

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood Draw

Other

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

Primary outcomes

  1. Phosphatidylethanol level as measured by blood draw.

    Time frame: Baseline

  2. Length of ICU stay measured in days

    Time frame: Up to 7 days

  3. Length of hospital stay measured in days

    Time frame: Up to 2 weeks

  4. Number of perioperative complications as measured by medical record review.

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Ayse Ulucay, MD

CONTACT

[email protected]

216-844-3771

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 7, 2025
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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