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NCT Number: NCT03223220

Quelling of Excitotoxicity in Acute Stroke With Ketamine

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Lankenau Medical Center

Wynnewood, Pennsylvania, 19096, United States

Location contact

Sudhir Aggarwal, MD, PhD

CONTACT

[email protected]

484-413-2572

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ketamine

Drug

IV infusion

Normal Saline

Other

IV infusion

Midazolam injection

Drug

Injection

Other names: Versed

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. NIH stroke scale score

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

  3. Depression score using the PHQ9 questionnaire

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

  4. Infarct volumes

    Time frame: On day 1, and day 4 or discharge whichever is earlier

    Measured from the DWI-MRI and/or CT images

  5. All cause mortality

    Time frame: 90 days

  6. Stroke-related mortality

    Time frame: 90 days

  7. Symptomatic intracranial hemorrhage

    Time frame: Day 4 or discharge whichever is earlier

  8. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Sudhir Aggarwal, MD, PhD

CONTACT

[email protected]

4844132572

Sponsors and collaborators

Lead sponsor

Lower Merion Neurology Research Foundation

Other

Registry information

Acronym: QUEST-KETA

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jul 21, 2017
Registry last updated
Dec 18, 2023

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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