Treatment of Refractory Status Epilepticus - Full Text View

Sponsored by:	Brigham and Women's Hospital
Information provided by:	Brigham and Women's Hospital
ClinicalTrials.gov Identifier:	NCT00265616

Purpose

The purpose of this study is to determine whether propofol or barbiturates should be preferred in the treatment of status epilepticus (continuous seizure activity) refractory to 2 standard antiepileptic agents.

Condition	Intervention	Phase
Status Epilepticus	Drug: propofol Drug: thiopental/pentobarbital	Phase III

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy

Drug Information available for: Pentobarbital sodium Thiopental sodium Pentobarbital Thiopental Propofol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized Clinical Trial for the Treatment of Refractory Status Epilepticus

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:

Proportion of patients with clinical and electrographical control of status epilepticus [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical outcome at day 21, assessed by a functional score [ Time Frame: 21 days ] [ Designated as safety issue: No ]
Time of ventilator treatment in survivors [ Time Frame: 10 days ] [ Designated as safety issue: No ]
Incidence of thromboembolism [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
Incidence of infectious complications requiring specific treatment [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
Incidence of hypotension requiring specific treatment [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
Incidence of propofol infusion syndrome [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	150
Study Start Date:	February 2008
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator propofol	Drug: propofol liquid, mg/kg.h, titrated after EEG
2: Active Comparator thiopental/pentobarbital	Drug: thiopental/pentobarbital liquid, mg/kg.h, titrated after EEG

Detailed Description:

Refractory status epilepticus (SE) develops in 31%-44% of patients with SE, with a mortality of 16%-23%. Coma induction is advocated for its management.

Propofol and barbiturates are the most used agents, but no comparative study has been performed. In consideration of the uncertainty regarding the relative effectiveness, despite several retrospective data, a prospective investigation is needed.

The objective is to assess the effectiveness (SE control, adverse events) of a first course of propofol versus barbiturates in the treatment of refractory SE, in adults with refractory SE not due to cerebral anoxia. Comparison: Coma induction with standardized doses of propofol or barbiturates titrated towards burst-suppression on EEG, then assessment of the proportion of patients achieving a control of SE.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with refractory status epilepticus not due to cerebral anoxia, needing coma induction for clinical management.

Exclusion Criteria:

Age < 16 years old.
Known pregnancy.
Cerebral anoxia as SE etiology.
Epilepsia partialis continua (simple partial SE).
Known intolerance to the study drugs.
Known mitochondrial disorder, hyperlipidemia, or significant rhabdomyolysis.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00265616

Contacts

Contact: Andrea O. Rossetti, MD	+11 41 21 314 1220	Andrea.Rossetti@chuv.ch
Contact: Edward B. Bromfield, MD	617-732-7547	ebromfield@partners.org

Locations

United States, Massachusetts
UMass Medical Center	Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Jayshree Narayanan, MD narayanj@ummhc.org
Contact: Catherine Phillips, MD PhillipC@ummhc.org
Sub-Investigator: Catherine Phillips, MD
Principal Investigator: Jaishree Narayanan, MD
Sub-Investigator: Nicholas Smyrnios, MD
Sub-Investigator: Richard Agababian, MD
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Andrew J. Cole, MD, FRCPC acole1@partners.org
Principal Investigator: Andrew J. Cole, MD, FRCPC
Sub-Investigator: Sydney Cash, MD, PhD
Sub-Investigator: Ronan Kilbride, MD
Sub-Investigator: Costello Daniel, MD
Sub-Investigator: Costas Michaelides, MD
Brigham and Women's Hospital	Recruiting
Boston, Massachusetts, United States, 02115
Contact: Edward B. Bromfield, MD ebromfield@partners.org
Principal Investigator: Edward B. Bromfield, MD
Sub-Investigator: Jong W. Lee, MD, PhD
Sub-Investigator: Autumn M. Klein, MD, PhD
Sub-Investigator: Tracey A. Milligan, MD
Sub-Investigator: Barbara A. Dworetzky, MD
United States, New Hampshire
Dartmouth-Hitchcock medical Center	Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Barbara C. Jobst, MD 603-650-8309 Barbara.C.Jobst@Hitchcock.org
Principal Investigator: Barbara C. Jobst, MD
Switzerland
Hôpitaux Universitaires de Genève	Recruiting
Geneva, Switzerland
Contact: Margitta Seeck, MD margitta.seeck@hcuge.ch
Principal Investigator: Margitta Seeck, MD
Sub-Investigator: Yvan Gasche, MD
Sub-Investigator: Anne-Chantal Heritier-Barras, MD
Sub-Investigator: Serge Vulliemoz, MD
Switzerland, BE
Inselspital	Recruiting
Bern, BE, Switzerland
Contact: Johannes Mathis, MD mathis@insel.ch
Principal Investigator: Johannes Mathis, MD
Spitalzentrum Biel	Recruiting
Biel/Bienne, BE, Switzerland, 2500
Contact: Filippo Donati, MD filippo.donati@insel.ch
Principal Investigator: Filippo Donati, MD
Switzerland, BS
Universtaetsspital	Recruiting
Basel, BS, Switzerland
Contact: Stephan Rueegg, MD srueegg@uhbs.ch
Principal Investigator: Stephan Rueegg, MD
Sub-Investigator: Peter Fuhr, MD
Sub-Investigator: Stephan Marsch, MD, PhD
Switzerland, SG
Kantonsspital	Recruiting
Sankt Gallen, SG, Switzerland
Contact: Barbara Tettenborn, MD barbara.tettenborn@kssg.ch
Principal Investigator: Barbara Tettenborn, MD
Sub-Investigator: Dominique Flügel, MD
Switzerland, VD
CHUV	Recruiting
Lausanne, VD, Switzerland
Contact: Andrea O. Rossetti, MD andrea.rossetti@chuv.ch
Principal Investigator: Andrea O. Rossetti, MD
Sub-Investigator: Marie-Denise Schaller, MD
Sub-Investigator: René Chiolero, MD
Sub-Investigator: Carlo Cereda, MD
Sub-Investigator: Vincianne Rey, MD
Sub-Investigator: Jan Novy, MD

Sponsors and Collaborators

Brigham and Women's Hospital

Investigators

Principal Investigator:	Edward B. Bromfield, MD	Brigham and Women's Hospital
Principal Investigator:	Andrea O. Rossetti, MD	BrighamHospital/CHUV

More Information

No publications provided

Responsible Party:	Brigham and Women's Hospital ( Bromfield Edward B, MD )
Study ID Numbers:	RSE study
Study First Received:	December 13, 2005
Last Updated:	January 29, 2009
ClinicalTrials.gov Identifier:	NCT00265616 History of Changes
Health Authority:	United States: Institutional Review Board; Switzerland: Swissmedic

Keywords provided by Brigham and Women's Hospital:

Refractory status epilepticus,
coma-induction,
treatment,
propofol,

barbiturates,
efficacy,
safety.

Study placed in the following topic categories:

Anesthetics, Intravenous
Neurotransmitter Agents
Thiopental
Adjuvants, Immunologic
Central Nervous System Diseases
Anesthetics
Central Nervous System Depressants
Brain Diseases

Coma
Pentobarbital
Anesthetics, General
Epilepsy
Status Epilepticus
Hypnotics and Sedatives
Propofol
Anticonvulsants

Additional relevant MeSH terms:

Anesthetics, Intravenous
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
Thiopental
Physiological Effects of Drugs
Nervous System Diseases
Anesthetics
Central Nervous System Depressants
Central Nervous System Diseases
Brain Diseases
Pharmacologic Actions

Adjuvants, Anesthesia
Pentobarbital
Anesthetics, General
Epilepsy
Status Epilepticus
Therapeutic Uses
Hypnotics and Sedatives
GABA Agents
Propofol
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on May 07, 2009