Clinical trial NCT06119919: Cardiac Injury With Convulsive Status Epilepticus
Official title: Cardiac Injury and it's Relation to Convulsive Status Epilepticus in Children
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Convulsive Status EPILEPTICUS
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all children admitted in Assiut University Hospitals Pediatrics department from 1 month to 16 years with convulsive status epilepticus

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

Detailed description: * Convulsive status epilepticus (CSE) is the most common life- threatening pediatric neurological emergency, with high morbidity and mortality rates . Previously, status epilepticus was defined as a seizure lasting more than 30 min . However, more recently, status epilepticus is considered if a patient has continuous seizure activity for 5 min or recurrent seizures without regaining consciousness level in between .
* Cardiac injury in CSE is associated with a combination of excessive catecholamine release, sympathetic overflow, and subsequent neurogenic myocardial stunning, resulting in subtle structural and functional myocardial damage with a high incidence of arrhythmia, stress-related cardiomyopathy, and heart failure moreover, cardiac injury may be iatrogenic due to intravenous fluid overload and cardio-depressive effects of anti-seizure medications (ASMs). Most of the SE-induced deaths occurring within 30 days following seizure activity are attributed to lethal cardiac arrhythmia, pulmonary edema, hypotension, and circulatory collapse
* Cardiac injury was defined as one or more of the following: (a) cardiac troponin ≥ 99th percentile , corrected for age and sex and (b) new- onset ECG changes categorized into ischemic changes, conduction abnormalities, or arrhythmias . (c) Left ventricular systolic or diastolic dysfunction, which is defined as follows: systolic dysfunction if EF \< 56% and/or FS \< 28% , diastolic dysfunction is defined and classified according to the recommendations of the American Society of Echocardiography and the European Association of Cardiovascular Imaging
* Changes in cardiac function in epilepsy imply an activation of the central autonomic network. In patients with seizures, epileptic discharges are thought to propagate to the central autonomic network and change or disturb normal autonomic control of vital cardiac functions. This activation of central autonomic nervous system is thought to be responsible for the peri-ictal autonomic cardiac symptoms observed in epilepsy patients. The importance of these autonomic features in the pathophysiology of epilepsy and its complications has become more clear in the last years.
* Conduction disorders seem to be common during seizures in intractable epilepsy could demonstrate the presence of arrhythmias or conduction disorders in seizures, particularly if these are prolonged or generalized. They include atrial fibrillation, supraventricular tachycardia and atrial and ventricular premature depolarisation. EKG changes, including T-wave inversion and ST-depression, were more frequent and potentially more dangerous in patients with generalized seizures.
* excessive autonomic stimulation may result in cardiac arrhythmias. But repetitive autonomic stimulation can also lead to structural damage to the heart. This increases the susceptibility to cardiac arrhythmias or ischemia. Myocardial fibrosis has already been found . Patients with uncomplicated seizures do not seem to have postictal troponin elevation, but signs of ischemia on ECG and elevated cardiac enzymes in epileptic patients suggest secondary cardiac damage could show presence of elevated Brain Natriuretic Peptide " BNP "and Creatine kinase Myocardial Band "CK-MB" in patients with seizures, the first evidence of subtle cardiac dysfunction in epilepsy patients.
* Cardiovascular-specific biomarkers have been identified as the most accurate indicators of myocardial infarction. Cardiovascular troponin-I (cTnI), in particular, is extremely selective for myocardial muscular tissue injury and is never produced following skeletal muscle injury .
* Patients with longlasting and multiple seizures seem to be prone to chronic dysfunction of autonomic cardiac control. In patients with newly diagnosed (median time 27 months) and untreated epilepsy, no difference was found in heart rate variability studied well controlled patients and refractory patients and could show with a series of autonomic tests that higher vasomotor tone, higher sympathetic tone, lower parasympathetic tone and reactivity was found in the group of refractory epilepsy patients. The observed dysautonomia could be a predisposing factor to SUDEP -sudden unexpected death in epilepsy. could demonstrate altered cardiovagal control in patients with chronic epilepsy.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Patients with hepatic diseases
2. patients with chronic renal illness
3. patients with endocrinal diseases
4. patients with musculoskeletal abnormalities
5. children with sepsis
6. congenital heart disease, myocarditis, myocardial disease, or arrhythmias; and children who survived cardiac surgery

Primary outcomes:
measure: cardiac injury and convulsive status epilepticus
timeFrame: baseline
measure: Cardiac injury and convulsive status epilepticus
timeFrame: Baseline
measure: Cardiac injury and convulsive status epilepticus
timeFrame: Baseline
measure: Cardiac injury and convulsive status epilepticus
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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