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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01686763
First Posted: September 18, 2012
Last Update Posted: March 18, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Luciana Mascia, University of Turin, Italy
  Purpose

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
Subarachnoid Hemorrhage, Aneurysmal

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Luciana Mascia, University of Turin, Italy:

Primary Outcome Measures:
  • cerebral vasospasm incidence [ Time Frame: 14 days ]

Enrollment: 35
Study Start Date: January 2004
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
subarachnoid hemorrhage disease
subarachnoid hemorrhage patients

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01686763


Sponsors and Collaborators
University of Turin, Italy
Investigators
Principal Investigator: Luciana Mascia, MD, PhD University of Turin, Italy
  More Information

Responsible Party: Luciana Mascia, MD, PhD, University of Turin, Italy
ClinicalTrials.gov Identifier: NCT01686763     History of Changes
Other Study ID Numbers: CEI 1147
First Submitted: September 12, 2012
First Posted: September 18, 2012
Last Update Posted: March 18, 2013
Last Verified: December 2009

Additional relevant MeSH terms:
Hemorrhage
Subarachnoid Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases