Clinical trial NCT06790810: Observational Study on Dynamic Changes of Blood Pressure During Post-epileptic Seizure Stage (OCBPS)
Official title: Observational Study on Dynamic Changes of Blood Pressure During Post-epileptic Seizure Stage: A Multicenter Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Epilepsy; Seizure
Blood Pressure
Keywords: Seizures
epilepsy
blood pressure
change
post-seizure
post-epileptic seizure stage
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
Collaborators: name: Fujian Medical University Union Hospital
name: The First Hospital of Hebei Medical University
name: Henan Provincial People's Hospital
name: The First Hospital of Jilin University
name: The First Affiliated Hospital with Nanjing Medical University
name: General Hospital of Ningxia Medical University
name: The Affiliated Hospital of Qingdao University
name: Shandong Provincial Hospital
name: Ruijin Hospital Luwan Branch
name: Shenzhen University General Hospital
name: Beijing Sanbo Brain Hospital
name: Xuanwu Jinan Hospital
name: First Affiliated Hospital Xi'an Jiaotong University
name: The Affiliated Hospital of Xuzhou Medical University
name: First Affiliated Hospital of Zhejiang University
name: The First Affiliated Hospital of Zhengzhou University
name: The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)
name: Peking Union Medical College Hospital
name: First Affiliated Hospital, Sun Yat-Sen University
First posted: 2025-01-24
Enrollment: 2000
Sex: ALL
Minimum age (years): 14
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inpatient epilepsy patients

Brief summary: This article details a multicenter study on changes of blood pressure and heart rate during post-epileptic seizure stage.

Detailed description: In contrast to the well-documented changes in heart rate and respiration, post-seizure changes in blood pressure have received insufficient attention. Fluctuations in blood pressure may worsen brain injury and elevate the risk of Sudden Unexpected Death in Epilepsy (SUDEP), yet evidence regarding postictal blood pressure changes remains limited.

This multicenter study aims to investigate the changes of blood pressure and heart rate during post-epileptic seizure stage in epilepsy patients, providing high-quality evidence on postictal hemodynamic changes and laying the foundation for future interventions. The study will enroll 2000 seizure events from hospitalized epilepsy patients aged 14-80 years between October 2024 and October 2025. Data on blood pressure, heart rate and blood oxygen will be collected during multiple time intervals post-seizure, alongside clinical information such as seizure type, duration, and medication use.

Eligibility criteria: Inclusion Criteria:

1. Age 14-80 years old, male and female;
2. Meet the diagnostic criteria for epilepsy, including focal epilepsy and generalized epilepsy.
3. Patients diagnosed with epilepsy, with at least one seizure during the hospitalization.
4. Seizures lasting longer than 30 seconds (including convulsive and non-convulsive status epilepticus, if seizure cessation can be determined and medications were recorded, they can be included).
5. Hypertensive patients who are on antihypertensive medication and have well-controlled blood pressure are eligible.
6. Patients who agree to participate in the study.

Exclusion Criteria:

1. Patients with structural heart disease, coronary artery disease (CAD), cardiomyopathy
2. Patients with severe systemic diseases
3. Pregnancy
4. Preictal seizures or myoclonic seizures.

Primary outcomes:
measure: Comparison of baseline blood pressure versus post-epileptic seizure blood pressure (systolic and diastolic)
timeFrame: within 1 hour
Secondary outcomes:
measure: Comparison of baseline heart rate versus post-epileptic seizure heart rate
timeFrame: within 1 hour
measure: Comparison of baseline blood-oxygen versus post-epileptic seizure blood-oxygen
timeFrame: within 1 hour
Other outcomes:
Locations:
city: Beijing
country: China
facility: Liankun Ren, MD
state: Beijing
Study officials:
affiliation: Study Principal Investigator
name: Liankun Ren, MD
role: PRINCIPAL_INVESTIGATOR
References: