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Observational Study on Dynamic Changes of Blood Pressure During Post-epileptic Seizure Stage (OCBPS)

Observational Study on Dynamic Changes of Blood Pressure During Post-epileptic Seizure Stage: A Multicenter Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06790810
Enrollment
1100
Registered
2025-01-24
Start date
2025-01-26
Completion date
2026-03-31
Last updated
2026-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure, Epilepsy; Seizure

Keywords

Seizures, epilepsy, blood pressure, change, post-seizure, post-epileptic seizure stage

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 1100 seizure events from hospitalized epilepsy patients aged 14-80 years between October 2024 and March 2026. 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.

Interventions

None listed

Sponsors

Xuanwu Hospital, Beijing
Lead SponsorOTHER
Fujian Medical University Union Hospital
CollaboratorOTHER
The First Hospital of Hebei Medical University
CollaboratorOTHER
Henan Provincial People's Hospital
CollaboratorOTHER
The First Hospital of Jilin University
CollaboratorOTHER
The First Affiliated Hospital with Nanjing Medical University
CollaboratorOTHER
General Hospital of Ningxia Medical University
CollaboratorOTHER
The Affiliated Hospital of Qingdao University
CollaboratorOTHER
Shandong Provincial Hospital
CollaboratorOTHER_GOV
Ruijin Hospital Luwan Branch
CollaboratorOTHER
Shenzhen University General Hospital
CollaboratorOTHER
Beijing Sanbo Brain Hospital
CollaboratorOTHER
Xuanwu Jinan Hospital
CollaboratorUNKNOWN
First Affiliated Hospital Xi'an Jiaotong University
CollaboratorOTHER
The Affiliated Hospital of Xuzhou Medical University
CollaboratorOTHER
First Affiliated Hospital of Zhejiang University
CollaboratorOTHER
The First Affiliated Hospital of Zhengzhou University
CollaboratorOTHER
The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)
CollaboratorOTHER
Peking Union Medical College Hospital
CollaboratorOTHER
First Affiliated Hospital, Sun Yat-Sen University
CollaboratorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
14 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Comparison of baseline blood pressure versus post-epileptic seizure blood pressure (systolic and diastolic)within 1 hourBaseline blood pressure and blood pressure measurements (systolic and diastolic) immediately after seizure (0-1 minute), at 3 minutes (2-4 minutes), 5 minutes (4-6 minutes), 10 minutes (9-11 minutes), 20 minutes (19-21 minutes), 30 minutes (29-31 minutes), and 60 minutes (59-61 minutes) post-seizure.

Secondary

MeasureTime frameDescription
Comparison of baseline heart rate versus post-epileptic seizure heart ratewithin 1 hourBaseline heart rate and heart rate measurements immediately after seizure (0-1 minute), at 3 minutes (2-4 minutes), 5 minutes (4-6 minutes), 10 minutes (9-11 minutes), 20 minutes (19-21 minutes), 30 minutes (29-31 minutes), and 60 minutes (59-61 minutes) post-seizure.
Comparison of baseline blood-oxygen versus post-epileptic seizure blood-oxygenwithin 1 hourBaseline oxygen saturation and oxygen saturation measurements immediately after seizure (0-1 minute), at 3 minutes (2-4 minutes), 5 minutes (4-6 minutes), 10 minutes (9-11 minutes), 20 minutes (19-21 minutes), 30 minutes (29-31 minutes), and 60 minutes (59-61 minutes) post-seizure.

Countries

China

Contacts

PRINCIPAL_INVESTIGATORLiankun Ren, MD

Study Principal Investigator

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 10, 2026