Back to resultsNIRS Directed Optimal Cerebral Perfusion Pressure on the Outcome of Aneurysmal Subarachnoid Hemorrhage Patients
Primary Purpose
Optimal Cerebral Perfusion Pressure on the Outcome of aSAH Patients
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Near-infrared spectroscopy (NIRS) and ICM+
Sponsored by
About this trial
This is an interventional treatment trial for Optimal Cerebral Perfusion Pressure on the Outcome of aSAH Patients
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years;
- Admitted to ICU because of aSAH.
- Predicted to stay in ICU ≥ 24 hours
- Provide written informed consent.
Exclusion Criteria:
- Unable to perform NIRS monitoring because of anatomic factors;
- Patients with severe organ failure;
- In addition to aneurysmal subarachnoid hemorrhage, there are other serious intracranial diseases (intracranial infection, cerebral hemorrhage, cerebral infarction, brain trauma, other patients after intracranial surgery);
- Patients with carotid plaque or thrombus;
- Patients with severe intracranial pneumatosis after craniotomy.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group
Optimal MAP group
Arm Description
Outcomes
Primary Outcome Measures
Neurological prognosis at the discharge from ICU and at 6 months
GOS score at 6 months
Secondary Outcome Measures
Full Information
NCT ID
NCT05003232
First Posted
June 21, 2021
Last Updated
August 10, 2021
Sponsor
Xiangya Hospital of Central South University
1. Study Identification
Unique Protocol Identification Number
NCT05003232
Brief Title
NIRS Directed Optimal Cerebral Perfusion Pressure on the Outcome of Aneurysmal Subarachnoid Hemorrhage Patients
Official Title
NIRS Directed Optimal Cerebral Perfusion Pressure on the Outcome of Aneurysmal Subarachnoid Hemorrhage Patients: A Multicenter, Single-blinded, Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2021 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xiangya Hospital of Central South University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
5. Study Description
Brief Summary
Objectives: To investigate the impact of NIRS directed optimal cerebral perfusion pressure on the outcome of aSAH patients.
Study design: A multicenter, single-blinded, randomized controlled trial. Setting: Departments of critical care medicine of tertiary hospitals in China. Patients: 150 aSAH patients (≥ 18 years old) who admitted to ICU (predicted ICU duration time ≥ 24 hours)
Intervention:
Patients with aSAH will be randomly divided into the control group and the intervention group. The control group will follow the SAH guidelines. The intervention group will be given continuous NIRS and invasive blood pressure monitoring at same time. The correlation curve between the brain oxygenation index or the brain hemoglobin index (ORI/THx) and the blood pressure will be obtained through continuous monitoring. According to the correlation curve, the optimal blood pressure will be determined which provides the optimal CPP. Then the goal of blood pressure (within 5 mmHg of CPPopt) will be maintained as the target of blood pressure management for the intervention group during ICU stay.
Primary outcome: Neurological prognosis (GCS score，GOS score, and NIHSS score when discharge from ICU; GOS score at 6 months), etc.
Predicted duration of the study: 2 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Optimal Cerebral Perfusion Pressure on the Outcome of aSAH Patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Title
Optimal MAP group
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Near-infrared spectroscopy (NIRS) and ICM+
Intervention Description
The intervention group will be given continuous NIRS and invasive blood pressure monitoring at same time. The correlation curve between the brain oxygenation index or the brain hemoglobin index (ORI/THx) and the blood pressure will be obtained through continuous monitoring. According to the correlation curve, the optimal blood pressure will be determined which provides the optimal CPP. Then the goal of blood pressure (within 5 mmHg of CPPopt) will be maintained as the target of blood pressure management for the intervention group during ICU stay.
Primary Outcome Measure Information:
Title
Neurological prognosis at the discharge from ICU and at 6 months
Description
GOS score at 6 months
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years;
Admitted to ICU because of aSAH.
Predicted to stay in ICU ≥ 24 hours
Provide written informed consent.
Exclusion Criteria:
Unable to perform NIRS monitoring because of anatomic factors;
Patients with severe organ failure;
In addition to aneurysmal subarachnoid hemorrhage, there are other serious intracranial diseases (intracranial infection, cerebral hemorrhage, cerebral infarction, brain trauma, other patients after intracranial surgery);
Patients with carotid plaque or thrombus;
Patients with severe intracranial pneumatosis after craniotomy.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
NIRS Directed Optimal Cerebral Perfusion Pressure on the Outcome of Aneurysmal Subarachnoid Hemorrhage Patients
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