ISRCTN14730035已完成3 期
Adjunct Low-Dose Ketamine Infusion versus Standard of Care in Mechanically Ventilated Critically Ill Patients at a Tertiary Saudi Hospital (ATTAINMENT Trial)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 85
研究概览
简要总结
2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32197636/ protocol (added 20/04/2020) 2021 Results article in https://doi.org/10.1186/s40560-021-00569-1 (added 01/09/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. ICU (Medical or surgical) patients (> 14 years old)
- •2. Mechanically ventilated within the previous 24 hours and expected to remain intubated for more than 24 hours.
- •3. Patient requires ongoing sedative medication
- •4. No objection from the ICU attending MD for enrollment
排除标准
- •Current participant exclusion criteria as of 19/03/2020:
- •1. Patients with a history of dementia or psychiatric disorders or on any anti-psychotics or anti-depressants medications at home
- •2. Pregnancy
- •3. Expected to need mechanical ventilation less than 24 hours
- •4. Known hypersensitivity to ketamine
- •5. Patient on dexmedetomidine as primary sedative agent prior to randomization
- •6. Patients with cardiogenic shock, heart failure, myocardial infarction
- •7. History of end-stage liver disease (Child Pugh score C)
- •8. Proven or suspected primary neurological injury (traumatic brain injury, ischemic stroke, intracranial hemorrhage, spinal cord injury, anoxic brain injury)
- •9. Patients with persistent heart rate (HR) > 150 bpm or systolic blood pressure (SBP) >180 mmHg
- •10. Patients who assigned as do-not-resuscitate order (DNR) or expected to die within 24 h
- •11. Patients on ECMO
- •12. Patients with status epilepticus patients who are receiving the ketamine infusion for refractory status epilepticus
- •13. Proven or suspected status asthmaticus
- •14. Patients with expected targeted RASS of -5 such as patients on continuous infusion neuromuscular blockade
- •Previous participant exclusion criteria:
- •1. Patients with a history of dementia or psychiatric disorders or on any anti-psychotics or anti-depressants medications at home
- •2. Pregnancy
- •3. Expected to need mechanical ventilation less than 24 hours
- •4. Known hypersensitivity to ketamine
- •5. Patient on dexmedetomidine as primary sedative agent prior to randomization
- •6. Patients with cardiogenic shock, heart failure, myocardial infarction
- •7. History of end-stage liver disease.
- •8. Proven or suspected primary neurological injury (traumatic brain injury, ischemic stroke, intracranial hemorrhage, spinal cord injury, anoxic brain injury)
- •9. Patients with persistent heart rate (HR) > 150 bpm or systolic blood pressure (SBP) >180 mmHg
- •10. Patients who assigned as do-not-resuscitate order (DNR) or expected to die within 24 hours
- •11. Patients on ECMO
- •12. Patients with status epilepticus patients who are receiving the ketamine infusion for refractory status epilepticus
- •13. Proven or suspected status asthmaticus
研究者
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