ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 16 of 198 for:    Recruiting, Not yet recruiting, Available Studies | "Heart Arrest"

Predictive Electrophysiological Score of the Neurological Prognosis Post Cardiac Arrest (CA-EEG)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02886039
Recruitment Status : Recruiting
First Posted : September 1, 2016
Last Update Posted : September 1, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:

Cardiac arrest (CA) is a major public health problem (1) because of its frequency (30000 to 50000 new cases of CA per year in France), a high mortality 80-90% and a relevant morbidity : 50% of survivors have cerebral sequela. Neurologic prognostication after CA is paramount. The American Academy of Neurology identifies accurate predictors of poor neurologic outcome (2): clinical examination findings such as no pupil response, no corneal reflexes, no motor response to stimulation and early myoclonus status epilepticus; biologic parameters like high neuron specific enolase (NSE) greater than 33 μg/L (3-4) and electrophysiologic results like flat electroencephalogram (EEG) or with burst suppression and Somatosensory evoked potentials (SEP) with no response to N20. Brain imaging may provide additional informations but not recommended yet. However, these pronotic markers were developed before the introduction therapeutic hypothermia (TH) (5-6). TH is now recommended after cardiac arrest by international guidelines, based on demonstration of improved survival and neurological recovery in comatose survivors of CA (7). TH and its associated use of sedative and paralytic agent may delay neurologic recovery and affect the optimal timing of prognostic variables (8).

Many classifications of electroencephalogram (EEG) (9-12) exist but no one is generally accept and recommended and they were created before TH.

In a preliminary study based on a retrospective cohort of 64 patients in CA with initial TH, we developped an electroencephalographic score to predict precocity the neurologic outcome according to the Cerebral performance category (CPC) (13-14).

The purpose of this study is to evaluate a simple and objective electroencephalographic score helpful to predict neurologic outcome after CA. Then, we would like to create a composite score to have a multimodal prognostication.

Patients and methods After CA resuscitation, all patients underwent coronary angioplasty if indicated and then were immediately admitted in emergency room of ICU. All patients were intubated and mechanically ventilated. Sedation was performed with continuous infusion of midazolam 0,15-0,2 mg/kg/h and sufentanil 0,15-0,2 μg/kg/h. All our patients were curarized with cisatracurium 0,2-0,3 mg/kg/h to prevent shivering during TH and took anti-epileptic medication phenobarbital 10-15 mg/ kg two times a day to prevent infra-clinic convulsive seizure.

Mild TH between 33 -34 °C was performed by active cooling with intravascular device (CoolGard® - Zoll, Chelmsford, UK) for 24 hours. Mean arterial pressure was maintained between [75-80] mmHg by titrated norepinephrine with or without inotropics (dobutamine, epinephrine) according cardiac output monitored by echocardiography.

After 24 hours of hypothermia, warming was started at a rate of 0.2 ° C/hr; neuromuscular blocking agents were arrested at 35.5°C and sedation at 36.5°C.

Neurological evaluation performed at 48 hours off sedation included a clinical evaluation (Glasgow score, myoclonus status, response to orders, motor response to stimulation, brain-stem reflexes). NSE was sampled between 48 and 72 H. EEGs were performed at Day-2, Day-3 and Day-5 off sedation and SEP at Day-5 off sedation. All EEGs were interpreted by two certified electroencephalographers blind from clinical neurologic outcome.

Survival and neurologic outcome according to CPC were assessed at ICU discharge and three months later.


Condition or disease Intervention/treatment Phase
Cardiorespiratory Arrest Other: Electroencephalogram Not Applicable

Detailed Description:

Electroencephalographic score

Reactivity Absence 1 Presence 0 Dominant frequency α (8-12 Hz) 0 θ (4-7,5 Hz) 1 δ (< 4 Hz) 2 Amplitude > 10 μV 0 < 10 μV 1 GPDs Absence 0 Presence 1 Burst Suppression Absence 0 Presence 1 Paroxysmal activity Absence 0 Presence 1

TOTAL


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Predictive Electrophysiological Score of the Neurological Prognosis Post Cardiac Arrest
Study Start Date : June 2014
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest
U.S. FDA Resources

Arm Intervention/treatment
patients
Patient with cardiac arrest benefiting an electroencephalogram
Other: Electroencephalogram
Prognostic evaluation of electroencephalogram score created with a retrospective cohort Creation of composite score to predict neurologic outcome in cardiorespiratory arrest



Primary Outcome Measures :
  1. comparison of electroencephalogram score to neurologic outcome evaluated by cerebral performance category [ Time Frame: J0 (date of inclusion) ]
    Intensive care unit discharge


Secondary Outcome Measures :
  1. comparison of electroencephalogram score to neurologic outcome evaluated by cerebral performance category [ Time Frame: 3 months ]


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
Criteria

Inclusion Criteria:

  • Patient > 18 years, hospitalized in resuscitation
  • Cardiac arrest in hospital or out
  • Collection of the written and informed consent

Exclusion Criteria:

  • Cardiorespiratory arrest concomitant with a neurological, traumatic or toxic pathology
  • History of cerebrovascular accident or cerebral anoxia
  • Patient whose family did not give an informed consent
  • Patient < 18 years

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): NCT02886039


Contacts
Contact: Jean Paul ROUSTAN, MD, PhD 04 67 33 82 56 JP-ROUSTAN@CHU-MONTPELLIER.FR

Locations
France
Hôpital Lapeyronie - Département Anesthésie Réanimation A Recruiting
Montpellier, France, 34295
Contact: Jean-Paul ROUSTAN, MH, PhD    04 67 33 82 56    JP-ROUSTAN@CHU-MONTPELLIER.FR   
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Principal Investigator: Jean Paul ROUSTAN, MD, PhD Montpellier University Hospital

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02886039     History of Changes
Other Study ID Numbers: UF 9389
First Posted: September 1, 2016    Key Record Dates
Last Update Posted: September 1, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by University Hospital, Montpellier:
Cardiorespiratory arrest
Neurologic outcome
Electroencephalogram
Somatosensory evoked potential
Synek classification
Cerebral performance category
Hypothermia

Additional relevant MeSH terms:
Heart Arrest
Heart Diseases
Cardiovascular Diseases