Treatment of Refractory Status Epilepticus - Full Text View

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

ChemIDplus related topics:

Propofol Thiopental Pentobarbital Pentobarbital sodium Thiopental sodium

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

Responsible Party:	Brigham and Women's Hospital ( Bromfield Edward B, MD )
Study ID Numbers:	RSE study
First Received:	December 13, 2005
Last Updated:	September 3, 2008
ClinicalTrials.gov Identifier:	NCT00265616
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:

Status epilepticus

Coma

Pentobarbital

Epilepsy

Thiopental

Status Epilepticus

Central Nervous System Diseases

Propofol

Brain Diseases

Additional relevant MeSH terms:

Anesthetics, Intravenous

Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action

GABA Modulators

Nervous System Diseases

Physiological Effects of Drugs

Anesthetics

Central Nervous System Depressants

Pharmacologic Actions

Adjuvants, Anesthesia

Anesthetics, General

Therapeutic Uses

Hypnotics and Sedatives

GABA Agents

Central Nervous System Agents

Anticonvulsants

ClinicalTrials.gov processed this record on October 10, 2008

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