Quelling of Excitotoxicity in Acute Stroke With Ketamine

Acute Ischemic Stroke Clinical Trial

— QUEST-KETA  

Official title:

Quelling of Excitotoxicity in Acute Stroke With Ketamine

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03223220
• Other study ID #: LMNRF-001
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: July 1, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: December 2023
• Source: Lower Merion Neurology Research Foundation
• Contact: Sudhir Aggarwal, MD, PhD
• Phone: 4844132572
• Email: saggarwal[@]lowermerionneurology.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemic Stroke
• Stroke

Intervention

Drug:
• Ketamine
IV infusion

Other:
• Normal Saline
IV infusion

Drug:
• Midazolam injection
Injection

Locations

Country	Name	City	State
United States	Lankenau Medical Center	Wynnewood	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Lower Merion Neurology Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in weighted modified Rankin scale score between day 1 and 90 will be assessed.	An improvement of 2 in mRS score will be considered favorable outcome.	On day 1 and at 90 days
Secondary	Barthel's index	An improvement of 10 or more points in Barthel's index will be considered a favorable outcome.	On day 1, and at 90 days
Secondary	NIH stroke scale score		On day 1, day 4 or discharge whichever is earlier, and at 90 days
Secondary	Depression score using the PHQ9 questionnaire		On day 1, and day 4 or discharge whichever is earlier.
Secondary	Infarct volumes	Measured from the DWI-MRI and/or CT images	On day 1, and day 4 or discharge whichever is earlier
Secondary	All cause mortality		90 days
Secondary	Stroke-related mortality		90 days
Secondary	Symptomatic intracranial hemorrhage		Day 4 or discharge whichever is earlier
Secondary	Deterioration in neurologic status	Increase of 4 or more points in the NIH stroke scale	Up to day 4 or discharge whichever is earlier