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

NCT00918970 | Terminated

• 2 other identifiers: 0708045CNIL 908.476
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

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

Keywords

autonomous nervous system; brain death; organs transplantation

Outcome Measures

Primary Outcomes (1)

• the delay between the falling down of autonomic nervous system activity and the confirmation of the brain death using cerebral angiography

  At confirmation of the brain death

Secondary Outcomes (1)

• the number of patients and the number of organs removed

  At the end of the study

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

subjects with severe cerebral lesions admitted in intensive care units

You may qualify if:

• severe cerebral lesions
• admitted in intensive care units

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Ministry of Health, France: collaborator

Study Sites (3)

CHU de Dijon

Dijon, 21000, France

Location

CH Roanne

Roanne, 42700, France

Location

CHU de Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Cerebral Hemorrhage, Traumatic; Brain Hemorrhage, Traumatic; Brain Injuries, Traumatic; Brain Death

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebral Hemorrhage; Intracranial Hemorrhages; Cerebrovascular Disorders; Intracranial Hemorrhage, Traumatic; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Coma; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David CHARIER, MD

  CHU de Saint-Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 8, 2009
• First Posted: June 11, 2009
• Study Start: August 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: June 15, 2009

Record last verified: 2009-06

Locations

FR (3)