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Electrographic Seizure Management and Neurobehavioral Outcomes in Critically Ill Children

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ClinicalTrials.gov Identifier: NCT03419260
Recruitment Status : Recruiting
First Posted : February 1, 2018
Last Update Posted : December 17, 2018
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Brief Summary:

Electrographic seizures are common in critically ill patients leading to increased use of resource-intense continuous EEG monitoring for seizure identification and management. When identified, electrographic seizures are generally treated with anti-seizure medications, but there are very limited data available regarding optimal treatment in terms of the efficacy or safety of specific anti-seizure medications or overall management strategies.

This is a single-center prospective observational study. The investigators aim to: (1) track critically ill patients undergoing clinically indicated EEG monitoring and seizure management to identify risk factors for electrographic seizures, (2) create prediction models guiding EEG monitoring resources to the patients at highest risk for seizures, and (3) evaluate our current management strategy in terms of safety.


Condition or disease Intervention/treatment
Seizures Other: Clinically indicated EEG monitoring.

Detailed Description:

Context: Electrographic seizures are common in critically ill patients leading to increased use of resource-intense continuous EEG monitoring for seizure identification and management. When identified, electrographic seizures are generally treated with anti-seizure medications, but there are very limited data available regarding optimal treatment in terms of specific medication selections or overall management strategies. The Children's Hospital of Philadelphia (CHOP) has a formal ICU EEG Monitoring Pathway aiming to standardize EEG monitoring and seizure management. This is a single-center prospective observational study of patients undergoing clinically indicated EEG monitoring to identify risk factors for electrographic seizures and create prediction models guiding limited EEG monitoring resources to the patients at highest risk for seizures, and also to evaluate the current seizure management strategy in terms of safety.

Objectives: The primary objective is to identify risk factors for electrographic seizures in critically ill patients and use these risk factors to create and validate a seizure prediction model. The secondary objective is to evaluate the safety of a targeted and timely electrographic seizure identification and management strategy among critically ill patients guided by a CHOP ICU EEG Monitoring Pathway.

Study Design: Single center observational study of consecutive patients undergoing clinically indicated EEG monitoring.

Setting/Participants: Single-center study of critically ill children in the Pediatric ICU at CHOP undergoing clinically indicated EEG monitoring and seizure management.


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Study Type : Observational
Estimated Enrollment : 900 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Electrographic Seizure Management and Neurobehavioral Outcomes in Critically Ill Children
Actual Study Start Date : March 13, 2017
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures

Group/Cohort Intervention/treatment
Cohort
Critically ill child undergoing clinically indicated EEG monitoring and electrographic seizure management.
Other: Clinically indicated EEG monitoring.
Children enrolled in the study will be undergoing clinically indicated EEG monitoring. Some children will undergo clinically indicated electrographic seizure management.




Primary Outcome Measures :
  1. Electrographic Seizure Occurrence [ Time Frame: 3 days ]
    Percentage of subjects who experience electrographic seizures.


Secondary Outcome Measures :
  1. Safety - Mortality [ Time Frame: 5 days ]
    Percentage of subjects with mortality related to electrographic seizure management.

  2. Safety - Occurrence of Cardiopulmonary adverse effects [ Time Frame: 5 days ]
    Percentage of subjects with cardiopulmonary adverse effects related to electrographic seizure management. Cardiopulmonary problems include subcategories of anaphylactic reactions, bradycardia (<5th percentile for age), hypotension (<5th percentile for age), hypoxemia (saturation <90%), lactic acidosis (>2 mmol/l), and intubation requirement.

  3. Safety - Occurrence of Organ Dysfunction [ Time Frame: 5 days ]
    Percentage of subjects with organ dysfunction adverse effects related to electrographic seizure management. Organ dysfunction that will include subcategories of allergic skin manifestations, acute kidney injury, hepatitis and acute liver injury, coagulopathy, and cytopenias (rbc, wbc, platelets).

  4. Safety -Occurrence of Hospital Acquired Infections [ Time Frame: 5 days ]
    Percentage of subjects with hospital acquired infection adverse effects related to electrographic seizure management. Hospital acquired infections that will include subcategories of central line associated bloodstream infections, urinary tract infection, and ventilator associated pneumonia.



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Ages Eligible for Study:   1 Month to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study is a prospective observational study of consecutive patients undergoing clinically indicated EEG monitoring in the Children's Hospital of Philadelphia Pediatric ICU as guided by an institutional ICU EEG Monitoring Pathway. Each subject will participate from the time of EEG monitoring initiation until the time of hospital discharge. This duration will generally be from several days to several weeks depending on the duration of the hospitalization.
Criteria

Inclusion Criteria:

  1. Care in the Children's Hospital of Philadelphia Pediatric ICU.
  2. Clinically indicated continuous EEG monitoring.
  3. Age > 1 month to 18 years.

Exclusion Criteria:

  1. Admitted for Phase 2 (intracranial) EEG monitoring.
  2. Intensivist expects to discontinue technological support in the next two days given underlying medical or neurological problems.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03419260


Contacts
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Contact: Nicholas S Abend, MD 215-590-1719 abend@chop.edu

Locations
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United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Nichoals S Abend, MD    215-590-1719      
Sponsors and Collaborators
Children's Hospital of Philadelphia
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: Nicholas S Abend, MD Children's Hospital of Philadelphia

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Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT03419260     History of Changes
Other Study ID Numbers: 17-013808
K02NS096058 ( U.S. NIH Grant/Contract )
First Posted: February 1, 2018    Key Record Dates
Last Update Posted: December 17, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Children's Hospital of Philadelphia:
seizures
status epilepticus
EEG monitoring
Additional relevant MeSH terms:
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Seizures
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms