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RecruitingNCT06864819Updated Sep 4, 2026

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

An observational study in Postoperative Complications and Alcohol Use Disorder, sponsored by University Hospitals Cleveland Medical Center. Recruiting at 1 site in United States. Open to participants aged 21 Years to 79 Years. Per ClinicalTrials.gov, last updated 2026-09-04.

Sponsored by University Hospitals Cleveland Medical Center · Observational

From the registry’s dates

  • Started May 2025; still recruiting 1 year 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
170
Ages
21 Years to 79 Years
Sex
All
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Study 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.

02

Conditions studied

  • Postoperative Complications
  • Alcohol Use Disorder

Keywords

  • alcohol consumption
  • surgical outcomes
03

In context

Postoperative Complications

1,332 studies on the registry are indexed under Postoperative Complications; 311 are open to participants now.

This study's planned enrollment of 170 is below the median of 251 across 537 observational studies indexed under Postoperative Complications.

Browse Postoperative Complications studies →

Lead sponsor

University Hospitals Cleveland Medical Center is the lead sponsor of 295 studies on the registry; 45 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 30 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients undergoing elective surgery at UHCMC.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
170 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients undergoing elective surgery at UHCMC.

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

    Other: Blood Draw

Interventions

  • OtherBlood Draw

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

06

What researchers measure

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.

    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

    Time frame: Up to six months

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Study locations

1 of 1 sites recruiting
  • University Hospital
    Cleveland, Ohio 44106, United States
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2025 (actual). Primary completion is estimated for Nov 2026, 18 months after the start.

Of 276 non-industry observational studies under Postoperative Complications, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's planned 18 months is below that.

Counting every sponsor, half of 281 studies reached it within 23 months; a quarter within 10 and three quarters within 39.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 3, 2025
First posted
Mar 7, 2025
StartActual
May 5, 2025
Primary completionEst.
Nov 15, 2026
CompletionEst.
Nov 15, 2026
Last update
Sep 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06864819
Responsible party
Salim M Hayek (Professor and Vice Chair for Clinical Research, Department of Anesthesiology, University Hospitals Cleveland Medical Center) — Principal investigator
First posted
Mar 7, 2025
Start date
May 5, 2025
Primary completion
Nov 15, 2026 (estimated)
Completion
Nov 15, 2026 (estimated)
Last update
Sep 4, 2026

Study contacts

Ayse Ulucay, MD
Contact
ayse.ulucay@uhhospitals.org
216-844-3771
Salim Hayek, MD, PhD
principal investigator · University Hospitals

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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