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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21-79
SponsorUniversity Hospitals Cleveland Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 population

Patients undergoing elective surgery at UHCMC.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Blood Draw

    Other intervention

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

Treatment groups

170 Participants
are divided into 1 treatment group
Group A: Patients undergoing elective surgery at UHCMC.1 intervention

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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