NCT00265616

Brief Summary

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2006

Typical duration for phase_3

Geographic Reach
2 countries

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 15, 2005

Completed
5 months until next milestone

Study Start

First participant enrolled

May 1, 2006

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

April 4, 2013

Completed
Last Updated

April 9, 2013

Status Verified

April 1, 2013

Enrollment Period

3.8 years

First QC Date

December 13, 2005

Results QC Date

October 27, 2010

Last Update Submit

April 2, 2013

Conditions

Status Epilepticus

Keywords

Refractory status epilepticus,coma-induction,treatment,propofol,barbiturates,efficacy,safety.

Outcome Measures

Primary Outcomes (1)

  • Refractory Status Epilepticus Controlled With First Course of Study Drug

    Control of status epilepticus refractory to benzodiazepines and a first antiepileptic drug after administration of the study drug; dichotomous assessment (yes/no)

    after return of continuous EEG activity (typically after 36 hours - 5 days)

Secondary Outcomes (5)

  • Clinical Outcome at Day 21

    21 days

  • Patients With Infectious Complications Requiring Specific Treatment

    10 days

  • Patients With Hypotension Requiring Specific Treatment

    10 days

  • Patients With Propofol Infusion Syndrome

    10 days

  • Intubation Time in Survivors

    Up to 3 months

Study Arms (2)

1

ACTIVE COMPARATOR

propofol, 2mg/kg as bolus, then titrated up to EEG burst-suppression as a continuous infusion; no maximum doses defined

Drug: propofol

2

ACTIVE COMPARATOR

thiopental/pentobarbital, 2mg/kg as bolus, then titrated up to EEG burst-suppression as a continuous infusion; no maximum doses defined

Drug: thiopental/pentobarbital

Interventions

propofolDRUG

liquid, mg/kg.h, titrated after EEG

Also known as: Disoprivan
1
thiopental/pentobarbitalDRUG

liquid, mg/kg.h, titrated after EEG

Also known as: Pentotal /Thiopentone
2

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Inselspital

Bern, Canton of Bern, Switzerland

Location

CHUV

Lausanne, Canton of Vaud, Switzerland

Location

Hôpitaux Universitaires de Genève

Geneva, Switzerland

Location

Related Publications (1)

  • Rossetti AO, Milligan TA, Vulliemoz S, Michaelides C, Bertschi M, Lee JW. A randomized trial for the treatment of refractory status epilepticus. Neurocrit Care. 2011 Feb;14(1):4-10. doi: 10.1007/s12028-010-9445-z.

    PMID: 20878265RESULT

MeSH Terms

Conditions

Status Epilepticus

Interventions

PropofolThiopentalPentobarbital

Condition Hierarchy (Ancestors)

SeizuresNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsThiobarbituratesBarbituratesPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Dr Andrea O. Rossetti
Organization
CHUV Lausanne
andrea.rosseti@chuv.ch
+41 21 314 1190

Study Officials

  • Andrea O. Rossetti, MD

    BrighamHospital/CHUV

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

December 13, 2005

First Posted

December 15, 2005

Study Start

May 1, 2006

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

April 9, 2013

Results First Posted

April 4, 2013

Record last verified: 2013-04

Locations

CH(3)US(2)