Postoperative ComplicationsNCT06864819
Role of Phosphatidylethanol in Predicting Perioperative Outcomes of Admitted Patients at UHCMC
An observational study of Postoperative Complications and Alcohol Use Disorder, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 79 years
- Conditions the study is for
- Postoperative Complications, Alcohol Use Disorder
- What is being tested?
- Blood Draw
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2025to 15 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing elective surgery at UHCMC.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University Hospital
Cleveland, Ohio, 44106
Ayse Ulucay, MD, 216-844-3771, ayse.ulucay@uhhospitals.org
About this study
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
- Being tested
- Blood Draw
- Keywords
- alcohol consumption, surgical outcomes
- Medical subject headings
- Postoperative Complications, Alcoholism, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood DrawOther
Patients will have a single blood sample sent for PEth testing, blood draws will happen during standard of care blood draw.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing elective surgery at UHCMC. | Patients will have a single blood sample sent for PEth testing. Receives: Other: Blood Draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phosphatidylethanol level as measured by blood draw.
Measured: Baseline
Length of ICU stay measured in days
Measured: Up to 7 days
Length of hospital stay measured in days
Measured: 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
Measured: Up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start5 May 2025
- Primary completion15 Nov 2026 (estimated)
- Study completion15 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salim M Hayek, University Hospitals Cleveland Medical Center
- Investigators
- Salim Hayek, MD, PhD, Principal investigator, University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06864819
- Sponsor's protocol ID
- STUDY20240892
- Status last verified
- Sep 2026
- First submitted
- 3 Mar 2025
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Phosphatidylethanol in Predicting Perioperative Outcomes of Admitted Patients at UHCMC
- ClinicalTrials.gov ID
- NCT06864819
- Acronym / sponsor ID
- STUDY20240892
- Conditions
- Postoperative Complications, Alcohol Use Disorder
- Keywords
- alcohol consumption, surgical outcomes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- 5 May 2025 (actual)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 7 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing elective surgery at UHCMC. | – | Other: Blood DrawPatients will have a single blood sample sent for PEth testing. |
Who may qualify
- Ages
- 21 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective surgery at UHCMC.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood DrawPatients will have a single blood sample sent for PEth testing, blood draws will happen during standard of care blood draw. | Other | Patients undergoing elective surgery at UHCMC. |
Primary outcome
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Salim Hayek, MD, PhD principal investigator
University Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Complications and Alcohol Use Disorder, run by University Hospitals Cleveland Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayse Ulucay, MD (216-844-3771, ayse.ulucay@uhhospitals.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phosphatidylethanol level as measured by blood draw. (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.