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

Subarachnoid Hemorrhage, Aneurysmal Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01686763
• Other study ID #: CEI 1147
• Status: Completed
• Phase: N/A
• First received: September 12, 2012
• Last updated: March 15, 2013
• Start date: January 2004

Study information

• Verified date: December 2009
• Source: University of Turin, Italy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hemorrhage
• Subarachnoid Hemorrhage
• Subarachnoid Hemorrhage, Aneurysmal

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Turin, Italy

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cerebral vasospasm incidence		14 days	No