TELSTAR: Treatment of ELectroencephalographic STatus Epilepticus After Cardiopulmonary Resuscitation

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.

Conditions

• Cardiac Arrest
• Anoxic Encephalopathy
• Status Epilepticus

Interventions

DRUG

Anti-epileptic drugs

Recommendations for the treatment of status epilepticus are based on recent international guidelines for treatment of overt status epilepticus. The objective of treatment with AED is to suppress all epileptiform activity. There is no clear proof that induction of a burst-suppression pattern is of additional value and induction of burst suppression is therefore not obligate. If the electroencephalographic status epilepticus returns after tapering sedative treatment at 24 hours, the procedure will be repeated. If the status returns after 2 x 24 hours, it will be considered refractory. Decisions regarding limitation or withdrawal of treatment will be done in accordance with the Dutch guideline "postanoxic coma". Reasons for withdrawal of treatment will be documented.

OTHER

No anti-epileptic drugs

The non-intervention group will be treated conform standard guidelines of treatment of comatose patients after cardiac arrest, but without anti-epileptic drugs or EEG based deep sedation. Treatment to suppress clinical myoclonia or seizures with low dose propofol is left to the discretion of the treating physician. Decisions regarding limitation or withdrawal of treatment will be done in accordance with the Dutch guideline "postanoxic coma". Reasons for withdrawal of treatment will be documented.

Sponsors & Collaborators

• Rijnstate Hospital

  collaborator OTHER

• Medisch Spectrum Twente

  collaborator OTHER

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  collaborator OTHER

• Radboud University Medical Center

  collaborator OTHER

• University Medical Center Groningen

  collaborator OTHER

• St. Antonius Hospital

  collaborator OTHER

• VieCuri Medical Centre

  collaborator OTHER

• Université Libre de Bruxelles

  collaborator OTHER

• Maasstad Hospital

  collaborator OTHER

• Maastricht University Medical Center

  collaborator OTHER

• Canisius-Wilhelmina Hospital

  collaborator OTHER

• University of Twente

  lead OTHER

Principal Investigators

• Jeannette Hofmeijer, MD PhD · Rijnstate Hospital and University of Twente

• Michel van Putten, MD PhD · Medisch Spectrum Twente and University of Twente

• Janneke Horn, MD PhD · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

• Barry Ruijter, MD · University of Twente

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-04-30

Primary Completion

2021-04-24

Completion

2022-01-24

Countries

• Belgium
• Netherlands

Study Locations