Trial Outcomes & Findings for Treatment of Refractory Status Epilepticus (NCT NCT00265616)

NCT ID: NCT00265616

Last Updated: 2013-04-09

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 23 participants
• Primary outcome timeframe: after return of continuous EEG activity (typically after 36 hours - 5 days)
• Results posted on: 2013-04-09

Participant Flow

Rcruitment in participating centers took part between 2006 and 2010.

Participant milestones

Measure	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.
Overall Study STARTED	14	9
Overall Study COMPLETED	14	9
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment of Refractory Status Epilepticus

Baseline characteristics by cohort

Measure	Propofol n=14 Participants titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)	Thiopental/Pentobarbital n=9 Participants titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)	Total n=23 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	4 Participants n=7 Participants	13 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	2 participants n=7 Participants	7 participants n=5 Participants
Region of Enrollment Switzerland	9 participants n=5 Participants	7 participants n=7 Participants	16 participants n=5 Participants

PRIMARY outcome

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

Population: Number of patients fulfilling primary outcome criteria

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

Outcome measures

Measure	Propofol n=14 Participants titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)	Thiopental/Pentobarbital n=9 Participants titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
Refractory Status Epilepticus Controlled With First Course of Study Drug	6 participants	2 participants

SECONDARY outcome

Timeframe: 21 days

Return to baseline clinical conditions (i.e.: no new handicap, no death)

Outcome measures

Measure	Propofol n=14 Participants titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)	Thiopental/Pentobarbital n=9 Participants titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
Clinical Outcome at Day 21	5 participants	3 participants

SECONDARY outcome

Timeframe: 10 days

Outcome measures

Measure	Propofol n=14 Participants titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)	Thiopental/Pentobarbital n=9 Participants titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
Patients With Infectious Complications Requiring Specific Treatment	7 participants	6 participants

SECONDARY outcome

Timeframe: 10 days

Outcome measures

Measure	Propofol n=14 Participants titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)	Thiopental/Pentobarbital n=9 Participants titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
Patients With Hypotension Requiring Specific Treatment	7 participants	5 participants

SECONDARY outcome

Timeframe: 10 days

Propofol infusion syndrome (PRIS) is a severe metabolic alteration with elevation of lactate, CK, and triglycerides.

Outcome measures

Measure	Propofol n=14 Participants titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)	Thiopental/Pentobarbital n=9 Participants titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
Patients With Propofol Infusion Syndrome	1 participants	0 participants

SECONDARY outcome

Timeframe: Up to 3 months

Outcome measures

Measure	Propofol n=14 Participants titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)	Thiopental/Pentobarbital n=9 Participants titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
Intubation Time in Survivors	4 days Interval 2.0 to 28.0	13.5 days Interval 8.0 to 70.0

Adverse Events

Propofol

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Thiopental/Pentobarbital

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Propofol n=14 participants at risk titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)	Thiopental/Pentobarbital n=9 participants at risk titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
Cardiac disorders propofol infusion syndrome (non fatal)	7.1% 1/14 • Number of events 1	0.00% 0/9
Gastrointestinal disorders paralytic ileus (fatal)	0.00% 0/14	11.1% 1/9 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Dr Andrea O. Rossetti

CHUV Lausanne

Phone: +41 21 314 1190

Email: andrea.rosseti@chuv.ch

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place