Endothelin-1 and Methabolites Concentrations in Mycrodialysis and Cerebrospinal Fluid in Subarachnoid Hemorrhage Patients

Endothelin-1 (ET-1) seems to be involved in the pathogenesis of cerebral vasospasm after subarachnoid hemorrhage. However measurements of cerebrospinal fluid concentrations (CSF) of ET-1 are not sensitive enough to predict the development of vasospasm representing the average value throughout the entire cerebral circulation. Cerebral microdialysis (MD) is a technique able to detect molecule concentrations in a small perivascular area. The investigators performed a prospective observational clinical study to test the hypothesis that MD ET-1 concentrations should be a sensitive predictor for vasospasm.

Patients with subarachnoid hemorrhage at high risk for vasospasm according to Fisher scale admitted to the ICU were consecutively studied. All patients received surgery within 48 hours from the bleeding; MD probe was placed in the area at risk for vasospasm after surgery and samples were hourly collected and analysed to measure lactate, piruvate and glutamate levels; ET-1 levels in CSF and MD fluids were measured from admission until day 7. At admission and after 7 days two angiographies were performed to detect the degree and extent of vasospasm, Transcranial Doppler and neurological evaluation were daily performed. Patients were then classified according to the presence of vasospasm in 3 groups: absence of vasospasm (NV), presence of vasospasm (CV), acute neurological deterioration (AND).

Study Overview

• Status: Completed
• Conditions: Subarachnoid Hemorrhage, Aneurysmal

• Study Type: Observational
• Enrollment (Actual): 35

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with subarachnoid hemorrhage at high risk for vasospasm according to Fisher scale admitted to the ICU were consecutively studied.

Description

Inclusion Criteria:

• diagnosys of subarachnoid hemorrhage
• angiographic proof of aneurysm
• admission within 24 hours from the subarachnoid hemorrhage
• presence of an intraventricular catheter and a microdialysis catheter placed either after admission or at the time of the surgery

Exclusion Criteria:

• moribund
• GCS=3
• denied consent

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
subarachnoid hemorrhage disease; subarachnoid hemorrhage patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
cerebral vasospasm incidence	14 days

Collaborators and Investigators

• Sponsor: University of Turin, Italy

Study record dates

Study Major Dates

• Study Start: January 1, 2004
• Primary Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: September 12, 2012
• First Submitted That Met QC Criteria: September 17, 2012
• First Posted (Estimate): September 18, 2012

Study Record Updates

• Last Update Posted (Estimate): March 18, 2013
• Last Update Submitted That Met QC Criteria: March 15, 2013
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Subarachnoid Hemorrhage
• Other Study ID Numbers: CEI 1147