Treatment of Refractory Status Epilepticus

This study has been terminated.
(Insufficient recruitment)
Sponsor:
Information provided by (Responsible Party):
Andrea O. Rossetti, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00265616
First received: December 13, 2005
Last updated: April 2, 2013
Last verified: April 2013
Results First Received: October 27, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Status Epilepticus
Interventions: Drug: propofol
Drug: thiopental/pentobarbital

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Rcruitment in participating centers took part between 2006 and 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Propofol titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG);no maximum doses defined.
Thiopental/Pentobarbital titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG); no maximum doses defined.

Participant Flow:   Overall Study
    Propofol     Thiopental/Pentobarbital  
STARTED     14     9  
COMPLETED     14     9  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Propofol titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
Thiopental/Pentobarbital titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
Total Total of all reporting groups

Baseline Measures
    Propofol     Thiopental/Pentobarbital     Total  
Number of Participants  
[units: participants]
  14     9     23  
Age  
[units: participants]
     
<=18 years     0     1     1  
Between 18 and 65 years     9     4     13  
>=65 years     5     4     9  
Gender  
[units: participants]
     
Female     7     6     13  
Male     7     3     10  
Region of Enrollment  
[units: participants]
     
United States     5     2     7  
Switzerland     9     7     16  



  Outcome Measures
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1.  Primary:   Refractory Status Epilepticus Controlled With First Course of Study Drug   [ Time Frame: after return of continuous EEG activity (typically after 36 hours - 5 days) ]

2.  Secondary:   Clinical Outcome at Day 21   [ Time Frame: 21 days ]

3.  Secondary:   Patients With Infectious Complications Requiring Specific Treatment   [ Time Frame: 10 days ]

4.  Secondary:   Patients With Hypotension Requiring Specific Treatment   [ Time Frame: 10 days ]

5.  Secondary:   Patients With Propofol Infusion Syndrome   [ Time Frame: 10 days ]

6.  Secondary:   Intubation Time in Survivors   [ Time Frame: Up to 3 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr Andrea O. Rossetti
Organization: CHUV Lausanne
phone: +41 21 314 1190
e-mail: andrea.rosseti@chuv.ch


Publications of Results:

Responsible Party: Andrea O. Rossetti, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00265616     History of Changes
Other Study ID Numbers: RSE study, protocol#62/06
Study First Received: December 13, 2005
Results First Received: October 27, 2010
Last Updated: April 2, 2013
Health Authority: United States: Institutional Review Board
Switzerland: Swissmedic