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临床试验/NCT05438641
NCT05438641已完成不适用

Retrospective Chart Review of Treatment of Alcohol Withdrawal Syndrome With Alpha-2 Agonists and/or Anticonvulsants

Stanford University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Change in Clinical Institute Withdrawal Assessment for Alcohol (CIWA) Score

研究概览

简要总结

Complicated alcohol withdrawal syndrome (AWS) increases morbidity and mortality of hospitalized, medically ill patients. The Psychosomatic Medicine Service is commonly consulted to assist in the management of these patients when admitted to medical/surgical units. During the last 15 months, the investigators have implemented a benzodiazepine-sparing management approach with very positive clinical outcomes. The BZDP-sparing protocol consists of a combination of alpha-2 agonist and/or anticonvulsant agents; all currently being used for the management of other medical conditions. This project intends to collect and analyze the data of all subjects managed with this approach to better understand its effectiveness and assess for potential adverse effects.

详细描述

Complicated alcohol withdrawal syndrome (C-AWS) increases morbidity and mortality of hospitalized, medically ill patients. The Psychosomatic Medicine Service is commonly consulted to assist in the management of these patients when admitted to medical/surgical units. During the last 15 months, the investigators have implemented a benzodiazepine-sparing management approach with very positive clinical outcomes. The BZDP-sparing protocol consists of a combination of alpha-2 agonist (e.g., clonidine, guanfacine, dexmedetomidine) and/or anticonvulsant agents (e.g., gabapentin, valproic acid, carbamazepine); all currently being used for the management of other medical conditions. The proposed study consists of an exhaustive chart review of these records to better understand the safety and effectiveness of alpha-2 agonists and anticonvulsants in the prophylaxis and treatment of AWS. Specifically the investigators want to understand the time to resolution of AWS symptoms, whether there are any limiting side effects to this regimen, and the need of for rescue with benzodiazepine agents. The information obtained from this study will be very helpful in assisting in the design of safer and more effective treatment of AWS.

研究设计

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

入排标准

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

入选标准

  • All the cases referred to the Psychosomatic Medicine Service for assistance with prophylactic or symptomatic management of AWS starting 8/1/2011 until 8/31/2014.

排除标准

  • Patients who through chart review were found to have been primarily suffering from delirium from causes other than AWS.

研究组 & 干预措施

Conventional Benzodiazepine-based treatment group

Conventional Benzodiazepine-based group includes any subject primarily treated with BZDP agents (e.g., diazepam, lorazepam, chlordiazepoxide).

干预措施: BZDP-Based Protocol (Drug)

Benzodiazepine-Sparing

BZDP-Sparing group includes subjects primarily treated with a non-BZDP agent (e.g., Alpha-2 agonists and/or anticonvulsants).

干预措施: BZDP-Sparing Protocol (Drug)

结局指标

主要结局

Change in Clinical Institute Withdrawal Assessment for Alcohol (CIWA) Score

时间窗: Baseline to month 6

The Clinical Institute Withdrawal Assessment for Alcohol (CIWA) measure is a ten item measure of alcohol withdrawal symptoms. The CIWA total score is the summation of 10 questions, with a range from 0 (little to no withdrawal) to 67 (worse alcohol withdrawal).

次要结局

  • Treatment Safety(Up to 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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