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Comparing Between CO2 and Phenylephrine Treatment in Patients With Progressive Lacunar Infarction (CARBOGEN Study)

NCT04839224 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2025-01-14

No results posted yet for this study

Summary

Lacunar infarction is an ischemic stroke occurred by small perforating artery occlusion . Twenty percent of ischemic stroke is lacunar infarction.

However, outcome of lacunar infarction is excellent, about 20-40% patients are suffered neurological worsening.

Progressive lacunar infarction is associated poor functional outcome and neurological deficit.

Currently, no treatment for progressive lacunar infarction is recommended on the guideline.

Several small study reported that phenylephrine and magnesium may be helpful for progressive lacunar infarction.

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.

Lacunar infarction is small and perfused with marginal flow by neighboring perforating arteriole.

Increased cerebral blood flow following dilation of cerebral arteriole by CO2 might halt and revert progressive lacunar infarction.

Induced hypertension is alternative treatment of progressive lacunar infarction. 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 versus phenylephrine in lacunar infarction patients who suffered neurological worsening.

Conditions

  • Acute Ischemic Stroke

Interventions

DRUG

carbogen

Patients will inhale carbogen gas for 10 minutes and rest for 50 minutes.

DRUG

phenylephrine

Start phenylephrine with 0.5 mg/hr and titrate upto 3.5 mg/hr or systolic blod pressure 200 mmHg.

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Principal Investigators

  • Hyo Suk Nam, MD, PhD · Department of Neurology, Yonsei University College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-05
Primary Completion
2022-10-18
Completion
2024-09-12

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04839224 on ClinicalTrials.gov