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NCT Number: NCT06770426

CompARing Between CO2 Phenylephrine and Phenylephrine Only Treatment in Patients With proGrEssing Cerebral infarctioN

Progressing stroke is associated poor functional outcome and neurological deficit.

Currently, no treatment for progressing stroke is recommended on the guideline.

Carbogen is a mixture of 5% CO2 with 95% O2. Carbogen is safe and it is used for the treatment of sudden sensory neural hearing loss or ocular ischemia.

CO2 dilate cerebral arteriole and concentration of CO2 is correlated with cerebral blood flow.

Increased cerebral blood flow following dilation of cerebral arteriole by CO2 might halt and revert progressing stroke.

Induced hypertension is alternative treatment of progressing stroke. Increasing blood pressure also induce cerebral blood flow. Phenylephrine is an α1 agonist, phenylephrine act on peripheral artery and little effect on cerebral artery or heart. Several studies reported that the effectiveness of phenylephrine on progressing stroke.

Therefore, this study will compare the effectiveness of carbogen + phenyleprhine versus phenlyephrine in progressing stroke patients.

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Brain Infarction Cardiovascular Diseases Central Nervous System Diseases Cerebral Small Vessel Diseases Cerebrovascular Disorders Infarction Ischemia Ischemic Stroke Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Stroke, Lacunar Thrombotic Stroke Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥20 years
  • Anterior circulation progressing stroke
  • Neurological worsening either 1 point in NIHSS score or MRC grade

Exclusion criteria

  • Age under 20 years.
  • Patients with cerebral infarction who are at risk of cerebral edema as determined by the investigator.
  • Patients with Moyamoya disease.
  • Patients with severe cerebrovascular reactivity (CVR) impairment due to cerebral vascular stenosis, making study participation challenging as determined by the investigator.
  • Patients unable to undergo CO2 treatment (e.g., panic disorder, anxiety disorders, or other psychiatric conditions).
  • Patients with hypersensitivity to phenylephrine.
  • Patients with persistent bradycardia (heart rate < 50 bpm).
  • Patients with a history of hemorrhagic stroke or at risk of cerebral hemorrhage.
  • Patients with a pre-stroke modified Rankin Scale (mRS) score ≥ 2, indicating impaired functional independence.
  • Patients ineligible for phenylephrine treatment due to any of the following:

Myocardial infarction or unstable angina within the past 3 months. Cardiac ejection fraction < 25%. Ventricular arrhythmia. Systolic blood pressure > 200 mmHg. Serum creatinine > 2 mg/dL. Pregnancy.

  • Use of monoamine oxidase (MAO) inhibitors.
  • Patients who do not consent to participate in the study.

Treatment and study plan

carbogen with or without phenyleprhine

Drug

Patients will inhale carbogen gas for 10 minutes and rest for 50 minutes. All patients will recevive phenyleprhine to increase blood pressure. Start phenylephrine with 0.5 mg/hr and titrate upto 3.5 mg/hr or systolic blod pressure 200 mmHg.

Phenylephrine

Drug

All patients will recevive phenyleprhine to increase blood pressure. Start phenylephrine with 0.5 mg/hr and titrate upto 3.5 mg/hr or systolic blod pressure 200 mmHg.

Primary outcomes

  1. percent improvement of NIHSS score in each group

    Time frame: 24 hours

    (baseline NIHSS score-post-treatment NIHSS score)/baseline NIHSS score×100

  2. difference of NIHSS score in each group

    Time frame: 24 hours

    baseline NIHSS score-post-treatment NIHSS score

  3. percent improvement of MRC score in each group

    Time frame: within 24 hours

    (baseline MRC score-post-treatment MRC score)/baseline MRC score×100

  4. difference of MRC score in each group

    Time frame: difference of MRC score in each group

    baseline MRC score-post-treatment MRC score

  5. Saftety outcome: Side effect

    Time frame: within 7 days

    Side effect (cerebral hemorrhage, myocardial infarction, Losing consciousness, difficulty breathing, dizziness, fatigue, headache, anxiety, etc)

  6. Saftety outcome: discontinuing patients

    Time frame: within 7 days

    Number of discontinuing patients due to side effects

Secondary outcomes

  1. Comparision between groups by percent improvement of NIHSS score

    Time frame: 24 hours

    (baseline NIHSS score-post-treatment NIHSS score)/baseline NIHSS score×100

  2. Comparision between groups by differnece of NIHSS score

    Time frame: 24 hours

    baseline NIHSS score-post-treatment NIHSS score

  3. Comparision between groups by percent improvement in MRC score

    Time frame: within 24 hours

    (baseline MRC score-post-treatment MRC score)/baseline MRC score×100

  4. Comparision between groups by difference of MRC score

    Time frame: within 24 hours

    baseline MRC score-post-treatment MRC score

  5. Functional independencec

    Time frame: 3 months after onset

    modifed Rankin score 0 to 2

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

CompARing Between CO2 Phenylephrine and Phenylephrine Only Treatment in Patients With proGrEssing Cerebral infarctioN(CARBOGEN Trial)

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 13, 2025
Registry last updated
Jan 20, 2025

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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