NIRS Directed Optimal Cerebral Perfusion Pressure on the Outcome of Aneurysmal Subarachnoid Hemorrhage Patients

Not Applicable

• Conditions: Optimal Cerebral Perfusion Pressure on the Outcome of aSAH Patients
• Interventions: Device: Near-infrared spectroscopy (NIRS) and ICM+

• Registration Number: NCT05003232
• Lead Sponsor: Xiangya Hospital of Central South University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-06
• Study First Submitted: 2021-06-21
• Study First Submitted QC: 2021-08-10
• Last Update Submitted: 2021-08-10
• Study First Posted: 2021-08-12
• Last Update Posted: 2021-08-12
• Study Start: 2021-09-01
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Optimal MAP group	Near-infrared spectroscopy (NIRS) and ICM+	-

Primary Outcome Measures

Name	Time	Method
Neurological prognosis at the discharge from ICU and at 6 months	6 months	GOS score at 6 months