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临床试验/NCT06864819
NCT06864819招募中不适用

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

University Hospitals Cleveland Medical Center1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2025年5月5日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
170
试验地点
1
主要终点
Phosphatidylethanol level as measured by blood draw.

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
21 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

研究组 & 干预措施

Patients undergoing elective surgery at UHCMC.

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

干预措施: Blood Draw (Other)

结局指标

主要结局

Phosphatidylethanol level as measured by blood draw.

时间窗: Baseline

Length of ICU stay measured in days

时间窗: Up to 7 days

Length of hospital stay measured in days

时间窗: Up to 2 weeks

Number of perioperative complications as measured by medical record review.

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Salim M Hayek

Professor and Vice Chair for Clinical Research, Department of Anesthesiology

University Hospitals Cleveland Medical Center

研究点 (1)

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