NCT06119919

Brief Summary

  1. 1.Determine the impact of cardiac injury on clinical profile, cardiac evaluation and outcome in patients hospitalized with convulsive status epilepticus (CSE).
  2. 2.Analyze the frequency of cardiac rhythm and conduction abnormalities related to seizures and determine risk factors and associated clinical characteristics.
  3. 3.Analyse ECG abnormalities and changes in HR in epileptic seizures since such disturbances might be a factor in SUDEP
  4. 4.Assessment of levels of cardiac enzymes in patients with status epilepticus

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2024

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

1 year

First QC Date

October 27, 2023

Last Update Submit

November 5, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • cardiac injury and convulsive status epilepticus

    Determine the impact of cardiac injury on clinical profile and outcome in patients with convulsive status epilepticus

    baseline

  • Cardiac injury and convulsive status epilepticus

    Analyze the frequency of cardiac rhythm and conduction abnormalities

    Baseline

  • Cardiac injury and convulsive status epilepticus

    Analyze ECG abnormalities and heart rate changes

    Baseline

  • Cardiac injury and convulsive status epilepticus

    Assessment of levels of cardiac enzymes in patients with status epilepticus

    Baseline

Eligibility Criteria

Age1 Month - 16 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

all children admitted in Assiut University Hospitals Pediatrics department from 1 month to 16 years with convulsive status epilepticus

You may qualify if:

  • children aged 1 month to 16 years presented with Convulsions
  • convulsions lasts more than 5 minutes or recurrent seizures without regaining consciousness in-between

You may not qualify if:

  • Patients with hepatic diseases
  • patients with chronic renal illness
  • patients with endocrinal diseases
  • patients with musculoskeletal abnormalities
  • children with sepsis
  • congenital heart disease, myocarditis, myocardial disease, or arrhythmias; and children who survived cardiac surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • Fogarasi A, Janszky J, Tuxhorn I. Autonomic symptoms during childhood partial epileptic seizures. Epilepsia. 2006 Mar;47(3):584-8. doi: 10.1111/j.1528-1167.2006.00472.x.

    PMID: 16529626BACKGROUND
  • Janszky J, Fogarasi A, Toth V, Magalova V, Gyimesi C, Kovacs N, Schulz R, Ebner A. Peri-ictal vegetative symptoms in temporal lobe epilepsy. Epilepsy Behav. 2007 Aug;11(1):125-9. doi: 10.1016/j.yebeh.2007.04.015. Epub 2007 Jun 20.

    PMID: 17584534BACKGROUND
  • Widdess-Walsh P, Kotagal P, Jeha L, Wu G, Burgess R. Multiple auras: clinical significance and pathophysiology. Neurology. 2007 Aug 21;69(8):755-61. doi: 10.1212/01.wnl.0000267650.50269.5d.

    PMID: 17709707BACKGROUND
  • Baumgartner C, Lurger S, Leutmezer F. Autonomic symptoms during epileptic seizures. Epileptic Disord. 2001 Sep;3(3):103-16.

    PMID: 11679301BACKGROUND
  • Nei M, Ho RT, Sperling MR. EKG abnormalities during partial seizures in refractory epilepsy. Epilepsia. 2000 May;41(5):542-8. doi: 10.1111/j.1528-1157.2000.tb00207.x.

    PMID: 10802759BACKGROUND
  • Natelson BH, Suarez RV, Terrence CF, Turizo R. Patients with epilepsy who die suddenly have cardiac disease. Arch Neurol. 1998 Jun;55(6):857-60. doi: 10.1001/archneur.55.6.857.

    PMID: 9626779BACKGROUND
  • Woodruff BK, Britton JW, Tigaran S, Cascino GD, Burritt MF, McConnell JP, Ravkilde J, Molgaard H, Andreasen F, Dam M, Jaffe AS. Cardiac troponin levels following monitored epileptic seizures. Neurology. 2003 May 27;60(10):1690-2. doi: 10.1212/01.wnl.0000065881.46964.4f.

    PMID: 12771269BACKGROUND
  • Tigaran S, Molgaard H, McClelland R, Dam M, Jaffe AS. Evidence of cardiac ischemia during seizures in drug refractory epilepsy patients. Neurology. 2003 Feb 11;60(3):492-5. doi: 10.1212/01.wnl.0000042090.13247.48.

    PMID: 12578934BACKGROUND
  • Chin RF, Neville BG, Peckham C, Bedford H, Wade A, Scott RC; NLSTEPSS Collaborative Group. Incidence, cause, and short-term outcome of convulsive status epilepticus in childhood: prospective population-based study. Lancet. 2006 Jul 15;368(9531):222-9. doi: 10.1016/S0140-6736(06)69043-0.

    PMID: 16844492BACKGROUND
  • Mitchell WG. Status epilepticus and acute serial seizures in children. J Child Neurol. 2002 Jan;17 Suppl 1:S36-43. doi: 10.1177/08830738020170010501.

    PMID: 11918461BACKGROUND

MeSH Terms

Conditions

Status Epilepticus

Condition Hierarchy (Ancestors)

SeizuresNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Christin Emad, resident

CONTACT

Mohammed Mahrous Eltellawy, professor

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
71515,Assiut

Study Record Dates

First Submitted

October 27, 2023

First Posted

November 7, 2023

Study Start

January 1, 2024

Primary Completion

January 1, 2025

Study Completion

March 1, 2025

Last Updated

November 7, 2023

Record last verified: 2023-11