We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Interest of Real Time Measurement of Autonomous Nervous System for the Detection of Brain Death (MEANS)

This study has been terminated.
(Angioscanners in excess of the SNA group because of use of thiopental)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00918970
First Posted: June 11, 2009
Last Update Posted: June 15, 2009
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.
Collaborator:
Ministry of Health, France
Information provided by:
Centre Hospitalier Universitaire de Saint Etienne
  Purpose

Context: A major lack of organ donors is a serious public health problem. It determines a prolonged delay before a transplant can be performed and thus a significant number of deaths of patients waiting for transplantation. The aim of this project is to reduce the delay of the diagnosis of brain death, and also to improve its diagnosis in the Intensive Care Unit.

The diagnosis of brain death is strictly defined by the law and relies either on two consecutive flat electroencephalograms recorded at an interval of four hours, or on the lack of cerebral circulation during a brain angiography performed after suspecting brain death on the clinical exam. However, in usual practice, it is difficult to have all the needed clinical arguments, and their interpretation can be difficult in the pathological context. This may participate in the delay and the lack of patients potentially donors.

Pre-study: In a pilot study, fifty subjects with severe cerebral lesions, had a continuous ECG recording. The investigators could find that a decrease in autonomic nervous system activity, as measured through the ECG, was correlated to the transition to brain death assessed by cerebral angiography. The loss of cardiac variability was always observed between two cerebral angiographies, one before and the second after brain death. This study allowed the investigators to calculate the threshold values of sympathetic and parasympathetic activities to confirm brain death.


Condition
Cerebral Hematoma, Traumatic Intracerebral Hemorrhage, Traumatic Traumatic Brain Hemorrhage Traumatic Brain Injury

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Interest of Real Time Measurement of Autonomous Nervous System for the Detection of Brain Death: the MEANS Study

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:
  • the delay between the falling down of autonomic nervous system activity and the confirmation of the brain death using cerebral angiography [ Time Frame: At confirmation of the brain death ]

Secondary Outcome Measures:
  • the number of patients and the number of organs removed [ Time Frame: At the end of the study ]

Enrollment: 30
Study Start Date: August 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
SNA group
This group will have a real-time analysis of autonomic nervous system activity during its intensive care hospitalisation
Clinical group
This group will have a conventional clinical analysis during its intensive care hospitalisation

Detailed Description:

Aim: The aim of this second study is to validate prospectively the interest of the analysis in real-time of autonomic nervous system activity to detect brain death.

Benefits expected: Increase the number of organ donors and the number of organs removal available for transplantation.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
subjects with severe cerebral lesions admitted in intensive care units
Criteria

Inclusion Criteria:

  • severe cerebral lesions
  • admitted in intensive care units

Exclusion Criteria:

  • neoplastic pathology
  • prior myocardiac infarction
  • hearth failure
  • atrial fibrillation
  • insulin-treated diabetes mellitus
  • cardiac pacemaker
  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): NCT00918970


Locations
France
CHU de Dijon
Dijon, France, 21000
CH Roanne
Roanne, France, 42700
CHU de Saint-Etienne
Saint-etienne, France, 42055
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Ministry of Health, France
Investigators
Principal Investigator: David CHARIER, MD CHU de Saint-Etienne
  More Information

Responsible Party: David CHARIER, CHU de SAINT-ETIENNE
ClinicalTrials.gov Identifier: NCT00918970     History of Changes
Other Study ID Numbers: 0708045
CNIL 908.476
First Submitted: June 8, 2009
First Posted: June 11, 2009
Last Update Posted: June 15, 2009
Last Verified: June 2009

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
autonomous nervous system
brain death
organs transplantation

Additional relevant MeSH terms:
Brain Injuries
Hemorrhage
Cerebral Hemorrhage
Hematoma
Brain Death
Intracranial Hemorrhages
Cerebral Hemorrhage, Traumatic
Brain Hemorrhage, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Pathologic Processes
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Coma
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Death
Intracranial Hemorrhage, Traumatic