Role of Phosphatidylethanol in Predicting Perioperative Outcomes of Admitted Patients at UHCMC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood Draw.
- Who it may be relevant to
- Registry conditions: Postoperative Complications, Alcohol Use Disorder. Basic parameters: 21 years — 79 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other 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 measures
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University Hospital — Cleveland
Identifiers
NCT: NCT06864819 · STUDY20240892