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临床试验/NCT04818827
NCT04818827已完成不适用

Ketamine Infusion as Sedative Analgesic in Severe ARDS on Mechanically Ventilated Patients

Interfaith Medical Center1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2020年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
124
试验地点
1
主要终点
All-Cause mortality

研究概览

简要总结

To evaluate whether ketamine is a safe sedative-analgesic agent to be used in an intensive care unit (ICU) setting as compared to traditionally used agents such as propofol, opioids, and midazolam

详细描述

According to the 2018 Clinical Practice Guidelines for the prevention and management of pain, agitation/sedation, delirium, immobility, and sleep disruption in adult patients in the intensive care unit (ICU), nonbenzodiazepine sedatives (such as propofol and dexmedetomidine) are preferable to benzodiazepine sedatives (such as midazolam and lorazepam) in critically ill, mechanically ventilated patients. Moreover, continuous use of benzodiazepine (more than 48 hours) has been associated with a risk of prolonged sedation and delirium. On the other hand, though propofol has a remarkable safety profile, it carries unfavorable side effects such as dose-dependent hypotension, hypertriglyceridemia, pancreatitis, and propofol syndrome (which is a rare but potentially fatal complication, associated with high-dose propofol infusions, and characterized by severe metabolic acidosis and circulatory collapse).

During the coronavirus disease 2019 (COVID-19) pandemic, an enormous number of patients required mechanical ventilation, which led to the shortage of traditional sedatives such as propofol, dexmedetomidine, midazolam, and lorazepam in the hospitals. In this challenging time, ketamine was used as an alternative sedative infusion. This study is to evaluate whether ketamine is safer compared to other sedatives in severe COVID related ARDS patients.

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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19 with an arterial partial pressure of oxygen divided by the inspired oxygen concentration (P/F) ratio < 150 with a minimum 5 cm of positive end-expiratory pressure on a mechanical ventilator

排除标准

  • post-cardiac arrest status,
  • premorbid diagnosis of dementia,
  • dependency on extra-corporeal therapies prior to or during ICU stay

结局指标

主要结局

All-Cause mortality

时间窗: 10 months (throughout the study period)

The two groups were compared for all-cause mortality during the ICU stay

次要结局

  • Infectious complications(10 months (throughout the study period))
  • Hemodynamic instability(10 months (throughout the study period))
  • Hospital length of stay(10 months (throughout the study period))
  • Acute Kidney Injury(10 months (throughout the study period))
  • Delirium after extubation(10 months (throughout the study period))
  • Duration of ventilator days(10 months (throughout the study period))

研究者

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

Ramakanth Pata

Pulmonary Fellow

Interfaith Medical Center

研究点 (1)

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