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:
Collaborator:
Ministry of Health, France
Information provided by:
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT00918970
First received: June 8, 2009
Last updated: June 12, 2009
Last verified: June 2009
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the number of patients and the number of organs removed [ Time Frame: At the end of the study ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: David CHARIER, CHU de SAINT-ETIENNE
ClinicalTrials.gov Identifier: NCT00918970     History of Changes
Other Study ID Numbers: 0708045, CNIL 908.476
Study First Received: June 8, 2009
Last Updated: June 12, 2009
Health Authority: France: French Data Protection Authority

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

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

ClinicalTrials.gov processed this record on October 21, 2014