Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Quelling of Excitotoxicity in Acute Stroke With Ketamine (QUEST-KETA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03223220
Recruitment Status : Not yet recruiting
First Posted : July 21, 2017
Last Update Posted : November 27, 2019
Sponsor:
Information provided by (Responsible Party):
Sudhir Aggarwal MD, PhD,, Lower Merion Neurology Research Foundation

Tracking Information
First Submitted Date  ICMJE July 14, 2017
First Posted Date  ICMJE July 21, 2017
Last Update Posted Date November 27, 2019
Estimated Study Start Date  ICMJE January 1, 2020
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2017)
Change in weighted modified Rankin scale score between day 1 and 90 will be assessed. [ Time Frame: On day 1 and at 90 days ]
An improvement of 2 in mRS score will be considered favorable outcome.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2017)
  • Barthel's index [ 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.
  • NIH stroke scale score [ Time Frame: On day 1, day 4 or discharge whichever is earlier, and at 90 days ]
  • Depression score using the PHQ9 questionnaire [ Time Frame: On day 1, and day 4 or discharge whichever is earlier. ]
  • Infarct volumes [ Time Frame: On day 1, and day 4 or discharge whichever is earlier ]
    Measured from the DWI-MRI and/or CT images
  • All cause mortality [ Time Frame: 90 days ]
  • Stroke-related mortality [ Time Frame: 90 days ]
  • Symptomatic intracranial hemorrhage [ Time Frame: Day 4 or discharge whichever is earlier ]
  • Deterioration in neurologic status [ Time Frame: Up to day 4 or discharge whichever is earlier ]
    Increase of 4 or more points in the NIH stroke scale
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Quelling of Excitotoxicity in Acute Stroke With Ketamine
Official Title  ICMJE Quelling of Excitotoxicity in Acute Stroke With Ketamine
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acute Ischemic Stroke
Intervention  ICMJE
  • Drug: Ketamine
    IV infusion
  • Other: Normal Saline
    IV infusion
  • Drug: Midazolam injection
    Injection
    Other Name: Versed
Study Arms  ICMJE
  • Experimental: Study Drug
    Will receive Ketamine infusion, and Midazolam (Versed).
    Interventions:
    • Drug: Ketamine
    • Drug: Midazolam injection
  • Placebo Comparator: Placebo
    Will receive Normal saline infusion and Midazolam (Versed).
    Interventions:
    • Other: Normal Saline
    • Drug: Midazolam injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 25, 2019)
120
Original Estimated Enrollment  ICMJE
 (submitted: July 18, 2017)
200
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. All patients who are 18 years or older, presenting or admitted to the study site with acute ischemic stroke, up to 24 hours since their last known well time
  2. An MRI evidence of acute ischemic infarct on the diffusion-weighted imaging with ADC correlate
  3. Pre-stroke modified Rankin scale of 0-2
  4. Patient should be willing to participate in the study by providing a written consent himself/herself or through a proxy.

Exclusion Criteria:

  1. Eligibility to receive IV Alteplase or intra-arterial thrombectomy/embolectomy
  2. Longer than 24 hours since last known well time
  3. Pre-stroke modified Rankin scale of 3 or above.
  4. Pregnant or lactating females
  5. Pre-existing psychiatric illness
  6. Intracranial hemorrhage of any type at presentation
  7. Seizure at onset of symptoms
  8. Sustained uncontrolled hypertension defined as Systolic Blood pressure greater than 185 mmHg or Diastolic Blood Pressure greater than 110 mmHg, despite administration of antihypertensive medications
  9. Known hypersensitivity or adverse reaction to prior administration of Ketamine
  10. Inability/refusal to provide consent by the patient or through a proxy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sudhir Aggarwal, MD, PhD 4844132572 saggarwal@lowermerionneurology.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03223220
Other Study ID Numbers  ICMJE LMNRF-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sudhir Aggarwal MD, PhD,, Lower Merion Neurology Research Foundation
Study Sponsor  ICMJE Lower Merion Neurology Research Foundation
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Lower Merion Neurology Research Foundation
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP