Lankenau Medical Center
Wynnewood, Pennsylvania, 19096, United States
NCT Number: NCT03223220
The investigators plan to undertake a phase II study to investigate the efficacy and side effects of intravenous ketamine to reduce neuroexcitotoxicity, and thus provide neuroprotection in patients diagnosed with acute ischemic stroke.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 2 / Phase 3
Wynnewood, Pennsylvania, 19096, United States
After obtaining informed consent, patients enrolled in the 'study drug' arm of the trial will receive Ketamine (1 mg/ml solution prepared in normal saline) infusion at a rate of 20 mg/h for a period of 24 hours. The infusion will start at a rate of 5 mg/h, and then gradually tapered up during the first 3 hours by 5 mg an hour. Similarly, the infusion rate will be gradually tapered down at a rate of 5 mg/h during the last 3 hours of infusion. The patients randomized to the 'placebo arm' of the trial will receive normal saline infusion at the same rates. In order to prevent the psychogenic adverse effects associated with Ketamine, the patients will be administered Midazolam at a dose of 1 mg IV every 4 hours. Midazolam will also be administered at the same rate to the patients randomized to the placebo arm. Blood Ketamine levels will be measured before starting the treatment, and daily while the infusion is on. While receiving treatment, the patients will be admitted to the telemetry floor in the hospital, on a monitored bed.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
IV infusion
IV infusion
Injection
Other names: Versed
Time frame: On day 1 and at 90 days
An improvement of 2 in mRS score will be considered favorable outcome.
Time frame: On day 1, and at 90 days
An improvement of 10 or more points in Barthel's index will be considered a favorable outcome.
Time frame: On day 1, day 4 or discharge whichever is earlier, and at 90 days
Time frame: On day 1, and day 4 or discharge whichever is earlier.
Time frame: On day 1, and day 4 or discharge whichever is earlier
Measured from the DWI-MRI and/or CT images
Time frame: 90 days
Time frame: 90 days
Time frame: Day 4 or discharge whichever is earlier
Time frame: Up to day 4 or discharge whichever is earlier
Increase of 4 or more points in the NIH stroke scale
Contact information is provided by the study sponsor or research team.
Lower Merion Neurology Research Foundation
Other
Acronym: QUEST-KETA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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