Image

Exogenous Ketone Esters for Refractory Status Epileptics

Exogenous Ketone Esters for Refractory Status Epileptics

Recruiting
1-10 years
All
Phase 2/3

Powered by AI

Overview

This study aims to investigate the efficacy of add-on exogenous ketone esters for the treatment of children with refractory generalized convulsive status epilepticus

Description

Generalized convulsive status epilepticus (GCSE) is a common neurological emergency in children with significant morbidity and mortality. Benzodiazepines (Bzs) are the initial anti-seizure medications (ASMs) for children with GCSE, but nearly a third of cases are not controlled by (Bzs). Moreover, about 40% of cases not responding to BZs are not controlled by second-line ASMs.

Ketogenic diet (KD) has been classically used for treating children with drug resistant epilepsy. Recently, KD has been used for refractory and super refractory status epilepticus. However, KD takes time to achieve ketosis and may be practically challenging in emergency situations and critically ill patients. Exogenous ketone esters (EKE) could be a more convenient and rapid way to achieve ketosis in acute settings.

Eligibility

Inclusion Criteria:

  • Refractory Generalized convulsive status epilepticus.

Exclusion Criteria:

  • Failure to obtain informed consent.
  • Recent intake of exogenous ketones, ketogenic diet, or any dietary restrictions/modifications.
  • Hemodynamic or cardio-respiratory instability.
  • Traumatic brain injury.
  • Hypo-/hyperglycemia.
  • Metabolic acidosis.
  • Ketosis (βHB > 2 mmol/L).
  • Associated severe disease condition, including hepatic, renal, respiratory, cardiac, gastrointestinal, endocrinal, and immune systems.
  • Malnutrition/obesity.
  • Limitations to nasogastric tube feeding.
  • Inborn errors of metabolism.
  • Allergies or any other contraindication to exogenous ketone esters.
  • Current or recent (within the last 24 hours) propofol therapy.
  • Intake of carbonic-anhydrase inhibitors.

Study details
    Status Epilepticus

NCT05674552

Sohag University

15 February 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.