Status:
COMPLETED
Analgosedative adjuncT keTAmine Infusion iN Mechanically vENTilated ICU Patients
Lead Sponsor:
King Faisal Specialist Hospital & Research Center
Conditions:
Critical Illness
Sedation
Eligibility:
All Genders
14+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to investigate the efficacy and safety of a low dose ketamine infusion used in combination of standard of care in critically ill patients to test whether ketamine can help...
Detailed Description
Ketamine is used to produce sedation and relieve pain to minimize discomfort while a breathing tube placed in trachea (windpipe) and a machine (ventilator) used in the ICU. Several publications have s...
Eligibility Criteria
Inclusion
- Adult ICU (Medical or surgical) patients (\> 14 years old)
- Mechanically ventilated within the previous 24 hours and expected to remain intubated for more than 24 hours.
- The patient requires ongoing sedative medication
- No objection from the ICU attending MD for enrollment
Exclusion
- Patients with a history of dementia or psychiatric disorders or on any anti-psychotics or anti-depressants medications at home
- Pregnancy
- Age \< 14 years old
- Expected to need mechanical ventilation less than 24 hours
- Known hypersensitivity to ketamine
- Patient on dexmedetomidine as primary sedative agent prior to randomization
- Patients with cardiogenic shock, heart failure, myocardial infarction
- History of end-stage liver disease.
- Proven or suspected primary neurological injury (traumatic brain injury, ischemic stroke, intracranial hemorrhage, spinal cord injury, anoxic brain injury)
- Patients with persistent heart rate (HR) \> 150 bpm or systolic blood pressure (SBP) \>180 mmHg
- Patients who assigned as do-not-resuscitate order (DNR) or expected to die within 24 hours
- Patients on ECMO
- Patients with status epilepticus patients who are receiving the ketamine infusion for refractory status epilepticus
- Proven or suspected status asthmaticus
- Patients with expected targeted RASS of -5 such as patients on continuous infusion neuromuscular blockade
Key Trial Info
Start Date :
August 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 6 2021
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT04075006
Start Date
August 28 2019
End Date
May 6 2021
Last Update
May 7 2021
Active Locations (1)
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1
King Faisal Specialist Hospital and Research Centre
Riyadh, Saudi Arabia, 11211