Ignite Creation Date:
2024-05-06 @ 4:30 PM
Last Modification Date:
2024-10-26 @ 2:11 PM
Study NCT ID:
NCT05003232
Status:
UNKNOWN
Last Update Posted:
2021-08-12
First Post:
2021-06-21
Brief Title:
NIRS Directed Optimal Cerebral Perfusion Pressure on the Outcome of Aneurysmal Subarachnoid Hemorrhage Patients
Sponsor:
Xiangya Hospital of Central South University
Organization:
Xiangya Hospital of Central South University
Study Overview
Official Title:
NIRS Directed Optimal Cerebral Perfusion Pressure on the Outcome of Aneurysmal Subarachnoid Hemorrhage Patients A Multicenter Single-blinded Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2021-06
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ORITHx 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 scoreGOS score and NIHSS score when discharge from ICU GOS score at 6 months etc
Predicted duration of the study 2 years
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 ORITHx 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 scoreGOS score and NIHSS score when discharge from ICU GOS score at 6 months etc
Predicted duration of the study 2 years
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None