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Outcome Measures

Primary Outcomes (6)

percent improvement of NIHSS score in each group
(baseline NIHSS score-post-treatment NIHSS score)/baseline NIHSS score×100
24 hours
difference of NIHSS score in each group
baseline NIHSS score-post-treatment NIHSS score
24 hours
percent improvement of MRC score in each group
(baseline MRC score-post-treatment MRC score)/baseline MRC score×100
within 24 hours
difference of MRC score in each group
baseline MRC score-post-treatment MRC score
difference of MRC score in each group
Saftety outcome: Side effect
Side effect (cerebral hemorrhage, myocardial infarction, Losing consciousness, difficulty breathing, dizziness, fatigue, headache, anxiety, etc)
within 7 days

Secondary Outcomes (5)

Comparision between groups by percent improvement of NIHSS score
24 hours
Comparision between groups by differnece of NIHSS score
24 hours
Comparision between groups by percent improvement in MRC score
within 24 hours
Comparision between groups by difference of MRC score
within 24 hours
Functional independencec
3 months after onset

Interventions

carbogen with or without phenyleprhineDrug

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.

Carbogen + phenylephrine group

phenylephrineDrug

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.

MeSH Terms

Conditions

Ischemic StrokeStroke, Lacunar

Interventions

carbogenPhenylephrine

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesCerebral Small Vessel DiseasesThrombotic StrokeBrain Infarction

Study Design

Study Type

interventional

Phase

phase 3

Allocation

RANDOMIZED

Masking

SINGLE

Who Masked

OUTCOMES ASSESSOR

Masking Details

Three months after discharge, the independence assessment will be perfomred by the researcher who don't know the patietns group.

Purpose

TREATMENT

Intervention Model

PARALLEL

Model Details: 1. The study is a single center, prospective, randomized, open-label trial with blinded end-point assessment (PROBE) design study. 2. For the patients with progressing stroke, the carbogen + phenylphrine group and the phenylephrine only group will be randomized by 1: 1 through web-based app. 3. Patients will be enrolled from February 2025 to September 2027 (based on the date of stroke). 4. We will collect medical history, laboratory findings, neurological scores, and functional recovery. 5. Functional recovery scores are performed by independent researchers in the blind state. 6. All data is collected using e-CRF, and the image study will be anonymized and sent to the central adjudication. 7. Central adjudication will review the image study.

Sponsor Type

OTHER

Responsible Party

SPONSOR

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (6)

Secondary Outcomes (5)

Study Arms (2)

Carbogen + phenylephrine group

Phenylephrine group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (6)

Secondary Outcomes (5)

Study Arms (2)

Carbogen + phenylephrine group

Phenylephrine group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations