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

Sponsor
University of Turin, Italy (Other)
Overall Status
Completed
CT.gov ID
NCT01686763
Collaborator
(none)
35
Enrollment

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    35 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Study Start Date :
    Jan 1, 2004
    Actual Primary Completion Date :
    Dec 1, 2008

    Arms and Interventions

    Arm Intervention/Treatment
    subarachnoid hemorrhage disease

    subarachnoid hemorrhage patients

    Outcome Measures

    Primary Outcome Measures

    1. cerebral vasospasm incidence [14 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Turin, Italy

    Investigators

    • Principal Investigator: Luciana Mascia, MD, PhD, University of Turin, Italy

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Luciana Mascia, MD, PhD, University of Turin, Italy
    ClinicalTrials.gov Identifier:
    NCT01686763
    Other Study ID Numbers:
    • CEI 1147
    First Posted:
    Sep 18, 2012
    Last Update Posted:
    Mar 18, 2013
    Last Verified:
    Dec 1, 2009
    Additional relevant MeSH terms:
    Subarachnoid Hemorrhage
    Hemorrhage

    Study Results

    No Results Posted as of Mar 18, 2013