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

Primary Purpose

Acute Ischemic Stroke

Status

Not yet recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Ketamine

Normal Saline

Midazolam injection

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke focused on measuring Stroke, Neuroprotection, Ketamine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
An MRI evidence of acute ischemic infarct on the diffusion-weighted imaging with ADC correlate
Pre-stroke modified Rankin scale of 0-2
Patient should be willing to participate in the study by providing a written consent himself/herself or through a proxy.

Exclusion Criteria:

Eligibility to receive IV Alteplase or intra-arterial thrombectomy/embolectomy
Longer than 24 hours since last known well time
Pre-stroke modified Rankin scale of 3 or above.
Pregnant or lactating females
Pre-existing psychiatric illness
Intracranial hemorrhage of any type at presentation
Seizure at onset of symptoms
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
Known hypersensitivity or adverse reaction to prior administration of Ketamine
Inability/refusal to provide consent by the patient or through a proxy

Sites / Locations

Lankenau Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Study Drug

Placebo

Arm Description

Will receive Ketamine infusion, and Midazolam (Versed).

Will receive Normal saline infusion and Midazolam (Versed).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Barthel's index

An improvement of 10 or more points in Barthel's index will be considered a favorable outcome.

NIH stroke scale score

Depression score using the PHQ9 questionnaire

Infarct volumes

Measured from the DWI-MRI and/or CT images

All cause mortality

Stroke-related mortality

Symptomatic intracranial hemorrhage

Deterioration in neurologic status

Increase of 4 or more points in the NIH stroke scale

Full Information

NCT ID

NCT03223220

First Posted

July 14, 2017

Last Updated

October 12, 2022

Sponsor

Lower Merion Neurology Research Foundation

1. Study Identification

Unique Protocol Identification Number

NCT03223220

Brief Title

Quelling of Excitotoxicity in Acute Stroke With Ketamine

Acronym

QUEST-KETA

Official Title

Quelling of Excitotoxicity in Acute Stroke With Ketamine

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

January 1, 2023 (Anticipated)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Lower Merion Neurology Research Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Ischemic Stroke

Keywords

Stroke, Neuroprotection, Ketamine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Study Drug

Arm Type

Experimental

Arm Description

Will receive Ketamine infusion, and Midazolam (Versed).

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Will receive Normal saline infusion and Midazolam (Versed).

Intervention Type

Drug

Intervention Name(s)

Ketamine

Intervention Description

IV infusion

Intervention Type

Other

Intervention Name(s)

Normal Saline

Intervention Description

IV infusion

Intervention Type

Drug

Intervention Name(s)

Midazolam injection

Other Intervention Name(s)

Versed

Intervention Description

Injection

Primary Outcome Measure Information:

Title

Change in weighted modified Rankin scale score between day 1 and 90 will be assessed.

Description

An improvement of 2 in mRS score will be considered favorable outcome.

Time Frame

On day 1 and at 90 days

Secondary Outcome Measure Information:

Title

Barthel's index

Description

An improvement of 10 or more points in Barthel's index will be considered a favorable outcome.

Time Frame

On day 1, and at 90 days

Title

NIH stroke scale score

Time Frame

On day 1, day 4 or discharge whichever is earlier, and at 90 days

Title

Depression score using the PHQ9 questionnaire

Time Frame

On day 1, and day 4 or discharge whichever is earlier.

Title

Infarct volumes

Description

Measured from the DWI-MRI and/or CT images

Time Frame

On day 1, and day 4 or discharge whichever is earlier

Title

All cause mortality

Time Frame

90 days

Title

Stroke-related mortality

Time Frame

90 days

Title

Symptomatic intracranial hemorrhage

Time Frame

Day 4 or discharge whichever is earlier

Title

Deterioration in neurologic status

Description

Increase of 4 or more points in the NIH stroke scale

Time Frame

Up to day 4 or discharge whichever is earlier

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 An MRI evidence of acute ischemic infarct on the diffusion-weighted imaging with ADC correlate Pre-stroke modified Rankin scale of 0-2 Patient should be willing to participate in the study by providing a written consent himself/herself or through a proxy. Exclusion Criteria: Eligibility to receive IV Alteplase or intra-arterial thrombectomy/embolectomy Longer than 24 hours since last known well time Pre-stroke modified Rankin scale of 3 or above. Pregnant or lactating females Pre-existing psychiatric illness Intracranial hemorrhage of any type at presentation Seizure at onset of symptoms 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 Known hypersensitivity or adverse reaction to prior administration of Ketamine Inability/refusal to provide consent by the patient or through a proxy

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sudhir Aggarwal, MD, PhD

Phone

4844132572

saggarwal@lowermerionneurology.com

Facility Information:

Facility Name

Lankenau Medical Center

City

Wynnewood

State/Province

Pennsylvania

ZIP/Postal Code

19096

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sudhir Aggarwal, MD, PhD

Phone

484-413-2572

saggarwal@lowermerionneurology.com

12. IPD Sharing Statement

Plan to Share IPD

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Quelling of Excitotoxicity in Acute Stroke With Ketamine

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