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Not yet recruiting NCT06770426

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

Phase III Interventional Acute Ischemic Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: carbogen with or without phenyleprhine, phenylephrine.
Who it may be relevant to
Registry conditions: Acute Ischemic Stroke. Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Drug carbogen with or without phenyleprhine
    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.
  • Drug phenylephrine
    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 outcome measures

  • percent improvement of NIHSS score in each group [Time frame: 24 hours]
  • difference of NIHSS score in each group [Time frame: 24 hours]
  • percent improvement of MRC score in each group [Time frame: within 24 hours]
  • difference of MRC score in each group [Time frame: difference of MRC score in each group]
  • Saftety outcome: Side effect [Time frame: within 7 days]
  • Saftety outcome: discontinuing patients [Time frame: within 7 days]
Secondary outcome measures (5)
  • Comparision between groups by percent improvement of NIHSS score [Time frame: 24 hours]
  • Comparision between groups by differnece of NIHSS score [Time frame: 24 hours]
  • Comparision between groups by percent improvement in MRC score [Time frame: within 24 hours]
  • Comparision between groups by difference of MRC score [Time frame: within 24 hours]
  • Functional independencec [Time frame: 3 months after onset]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • Yonsei University Health System, Severance Hospital — Seoul

Identifiers

NCT: NCT06770426 · 4-2024-1415

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗