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

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ClinicalTrials.gov Identifier: NCT01686763
Recruitment Status : Completed
First Posted : September 18, 2012
Last Update Posted : March 18, 2013
Sponsor:
Information provided by (Responsible Party):
Luciana Mascia, University of Turin, Italy

Tracking Information
First Submitted Date September 12, 2012
First Posted Date September 18, 2012
Last Update Posted Date March 18, 2013
Study Start Date January 2004
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 10, 2013)
cerebral vasospasm incidence [ Time Frame: 14 days ]
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT01686763 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Endothelin-1 and Methabolites Concentrations in Mycrodialysis and Cerebrospinal Fluid in Subarachnoid Hemorrhage Patients
Official Title Not Provided
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).

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Subarachnoid Hemorrhage, Aneurysmal
Intervention Not Provided
Study Groups/Cohorts subarachnoid hemorrhage disease
subarachnoid hemorrhage patients
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 17, 2012)
35
Original Actual Enrollment Same as current
Study Completion Date Not Provided
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01686763
Other Study ID Numbers CEI 1147
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Luciana Mascia, University of Turin, Italy
Study Sponsor University of Turin, Italy
Collaborators Not Provided
Investigators
Principal Investigator: Luciana Mascia, MD, PhD University of Turin, Italy
PRS Account University of Turin, Italy
Verification Date December 2009