DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



TELSTAR: Treatment of ELectroencephalographic STatus Epilepticus After Cardiopulmonary Resuscitation

Information source: University of Twente
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cardiac Arrest; Anoxic Encephalopathy; Status Epilepticus

Intervention: Anti-epileptic drugs (Drug); No anti-epileptic drugs (Other)

Phase: N/A

Status: Recruiting

Sponsored by: University of Twente

Official(s) and/or principal investigator(s):
Jeannette Hofmeijer, MD PhD, Principal Investigator, Affiliation: Rijnstate Hospital and University of Twente
Michel van Putten, MD PhD, Principal Investigator, Affiliation: Medisch Spectrum Twente and University of Twente
Janneke Horn, MD PhD, Principal Investigator, Affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Barry Ruijter, MSc, Study Director, Affiliation: University of Twente

Overall contact:
Jeannette Hofmeijer, MD PhD, Phone: 0031-88-0058877, Email: jhofmeijer@rijnstate.nl

Summary

The purpose of this study is to estimate the effect of medical treatment of electro-encephalographic status epilepticus on neurological outcome of patients with postanoxic encephalopathy after cardiac arrest.

Clinical Details

Official title: TELSTAR: Treatment of ELectroencephalographic STatus Epilepticus After Cardiopulmonary Resuscitation

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Neurological outcome

Secondary outcome: Long term outcome

Detailed description: Rationale: Electroencephalographic status epilepticus is described in 9-35% of patients with postanoxic encephalopathy after cardiac arrest and is associated with case fatality rates of 90-100%. It is unclear whether (some) electroencephalographic seizure patterns in these patients represent a condition which can be treated with antiepileptic drugs to improve outcome, or have to be regarded as an expression of severe ischemic damage, in which treatment with antiepileptic would be futile. Therefore, both treatment with and treatment without antiepileptic drugs are considered standard modalities in these patients. We aim to compare these standard strategies and hypothesize that aggressive and early treatment of electro-encephalographic status epilepticus with antiepileptic drugs improves outcome as compared to treatment without these drugs. Objective: To estimate the effect of medical treatment of electro-encephalographic status epilepticus on neurological outcome of patients with postanoxic encephalopathy after cardiac arrest Study design: We will perform a multicenter clinical trial with randomized treatment allocation, open label treatment and blinded endpoint evaluation (PROBE design). The intervention contrast will be aggressive medical treatment vs. no treatment of electroencephalographic status epilepticus, in addition to standard best medical management of comatose patients after cardiac arrest, including mild therapeutic hypothermia. Study population: The study population will consist of adult patients with postanoxic encephalopathy after cardiac arrest, admitted to the intensive care unit, with electroencephalographic status epilepticus on continuous EEG, who are eligile for inclusion in this trial. Intervention: Treatment of electroencephalographic status epilepticus will be based on guidelines for treatment of overt status epilepticus. The objective of this treatment will be to suppress all epileptiform activity in the EEG. If the electroencephalographic status epilepticus will return after tapering sedative treatment at 24 hours, the procedure will be repeated. If the status will return after 2 x 24 hours, it will be considered refractory. Main study parameters/endpoints: The primary outcome measure will be neurological outcome defined as the score on the Cerebral Performance Category (CPC) at 3 months dichotomized as good (CPC 1-2 = no or moderate neurological disability) and poor (CPC 3-5 = severe disability, coma, or death).

Sample size: With a presumed reduction of poor outcome of 7%, from 99% - 92%, alpha of 5%,

power of 80%, one tailed testing, and one interim analysis by an independent data safety and monitoring board, the objected number of inclusions is 172. With an estimation of an incidence of electroencephalographic status epilepticus of 20% in patients with postanoxic coma, the total number of patients to be monitored will be 860. Nature and extent of the burden and risks associated with participation: Medical treatment of electroencephalographic status epilepticus may modify the high risk of death. Otherwise, this treatment of electroencephalographic status epilepticus may lead to prolonged hospitalization of several days of comatose patients that otherwise would have died. The risk of an increase of morbidity or mortality on the longer term is considered negligible.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients after cardiac arrest with suspected postanoxic encephalopathy

- Age 18 years or older

- Continuous EEG with at least eight electrodes started within 24 hours after cardiac

arrest

- Electroencephalographic status epilepticus on continuous EEG

- Informed consent given by a legal representative

- Possibility to start treatment within three hours after detection of

electroencephalographic status epilepticus. Exclusion Criteria:

- A known history of another medical condition with limited life expectancy (<6 months)

- Any progressive brain illness, such as a brain tumor or neurodegenerative disease

- Pre-admission Glasgow Outcome Scale score of 3 or lower

- Reason other than neurological condition to withdraw treatment

- Known participation in any interventional study

Locations and Contacts

Jeannette Hofmeijer, MD PhD, Phone: 0031-88-0058877, Email: jhofmeijer@rijnstate.nl

Radboud University Medical Center, Nijmegen, Geert Grooteplein-Zuid 10 6525 GA, Netherlands; Recruiting
Astrid Hoedemaekers, MD PhD, Phone: 0031-24- 3611111, Email: Astrid.Hoedemaekers@radboudumc.nl

Medisch Spectrum Twente, Enschede, Haaksbergerstraat 55 7513 ER, Netherlands; Recruiting
Michel van Putten, MD PhD, Phone: 0031-53-4872810, Email: m.j.a.m.vanputten@utwente.nl

University Medical Center Groningen, Groningen, Hanzeplein 1 9700 RB, Netherlands; Recruiting
Walter van den Bergh, MD PhD, Phone: 0031-50-3616161, Email: w.m.van.den.bergh@umcg.nl

Academic Medical Center, Amsterdam, Meibergdreef 9 1105 AZ, Netherlands; Recruiting
Janneke Horn, MD PhD, Phone: 0031-20-566 9111, Email: j.horn@amc.uva.nl

Rijnstate Hospital, Arnhem, Wagnerlaan 55 6815 AD, Netherlands; Recruiting
Jeannette Hofmeijer, MD PhD, Phone: 0031-88-0058877, Email: jhofmeijer@rijnstate.nl

Additional Information

Starting date: April 2014
Last updated: December 1, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017