Ketamine Infusion in Neurologic Deficit (KIND)
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|ClinicalTrials.gov Identifier: NCT02636218|
Recruitment Status : Recruiting
First Posted : December 21, 2015
Last Update Posted : April 17, 2018
Subarachnoid hemorrhage (SAH) or bleeding in the brain as a result of ruptured aneurysm is a devastating type of stroke. Many patients who undergo emergent neurosurgery to repair the aneurysm and remove the bleeding suffer from complications in their subsequent hospital stay, the most frequent and morbid of which is delayed cerebral ischemia (DCI) or small strokes resulting from impaired blood flow to certain vital brain centers. This occurs because of changes to the brain's blood vessels that occur after the bleed. The arteries can become narrow (spasm) or small clots can form within the vasculature that disrupts normal blood flow. Patients are left with profound neurologic deficits from these secondary complications.
Anesthesiologists, neurosurgeons, and intensivists are in need of a way to protect the brain during this vulnerable period following aneurysm repair. One drug that may provide such protection is ketamine, a compound frequently used in operating rooms and intensive care units to provide anesthesia and analgesia. Ketamine works by blocking glutamate receptor ion channels that play a pivotal role in promoting brain cell death during strokes by flooding the brain with too much calcium and dangerous chemicals. This project is designed to test the efficacy of ketamine in protecting the brain following aneurysm repair by using a controlled infusion of the drug in the intensive care unit (ICU) when patients return from their operation.
|Condition or disease||Intervention/treatment||Phase|
|Subarachnoid Hemorrhage||Drug: Ketamine Drug: 0.9% NaCl||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Pilot Study of Sub-anesthetic Ketamine Infusion for Neuroprotection After Aneurysmal Subarachnoid Hemorrhage: Effects on White Matter Integrity, Inflammatory Biomarkers and Neurocognitive Outcome|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||February 2019|
Active Comparator: 0.9% NaCl control
Drug: 0.9% NaCl
500 ml of 0.9% NaCl infused at 5 ug/kg/min for 4 hours.
Other Name: NS
500 ml of ketamine (0.2 mg/ml) infused at 5 ug/kg/min for 4 hours.
Other Name: Ketamine HCl
- Changes in physiologic parameters as specified below [ Time Frame: During infusion and 1 hour post-infusion ]Temperature, heart rate (HR), mean arterial pressure (MAP), intracranial pressure (ICP), central venous pressure (CVP) if available, peak airway pressure (PAP) if available, end-tidal carbon dioxide (ETCO2) will be evaluated during infusion. Collected measurement data will be analyzed based on the occurrence of adverse events such as increase in ICP by more than 3 mmHg, increase in HR by more than 30 bpm, increase in partial pressure of CO2 (pCO2) by more than 20 mmHg, increase in lactate by more than 0.5, drop in pH by more than 0.2, increase in systolic blood pressure (SBP0 to over 200 mmHg, or any other unforeseen event that is deemed to be related to the drug treatment with adverse effects on the patient.
- Biologic samples [ Time Frame: Day 1-2 post-infusion ]Blood and cerebrospinal fluid (CSF) samples will be collected and analyzed for biomarker levels which would indicate extent of neuronal injury.
- Neurocognitive test Montreal Cognitive Assessment Scale (MoCA) [ Time Frame: Day 30 or Day 60 post-DCI ]Neurocognitive function will be assessed using the MoCA to determine preliminary effects of ketamine on neurocognitive outcome.
- Neurocognitive test modified Rankin Scale (mRS) [ Time Frame: Day 30 or Day 60 post-DCI ]Neurocognitive function will be assessed using the mRS determine preliminary effects of ketamine on neurocognitive outcome.
- Brain imaging using Magnetic Resonance Imaging (MRI) [ Time Frame: Day 30 or Day 60 post-DCI ]Structural and functional brain imaging will be conducted using Tesla MRI system to assess white matter integrity.
- Hospital anxiety and depression score [ Time Frame: Day 30 or Day 60 post-DCI ]Assessments for neuro-cognitive outcomes and correlation with MRI findings
- EQ-5D-5L [ Time Frame: Day 30 or Day 60 post-DCI ]Neurocognitive outcome assessment and correlation with MRI results
- Trail making test [ Time Frame: Day 30 or Day 60 post-DCI ]Neurocognitive outcome assessment and correlation with MRI results
- Verbal fluency tests [ Time Frame: Day 30 or Day 60 post-DCI ]Neurocognitive outcome assessment and correlation with MRI results
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02636218
|Contact: Marlene S. Santos, MD||416-864-6060 ext firstname.lastname@example.org|
|Contact: Joshua Bell, MD, PhDemail@example.com|
|St Michael's Hospital||Recruiting|
|Toronto, Ontario, Canada, M5B 1W8|
|Principal Investigator: Andrew Baker, MD|
|Principal Investigator:||Andrew Baker, MD, FRCPC||St. Michael's Hospital, Toronto|