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

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

Study Overview

• Status: Completed
• Conditions: Blood Pressure; Epilepsy; Seizure

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.

• Study Type: Observational
• Enrollment (Actual): 1100

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100053
      • Liankun Ren, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Inpatient epilepsy patients

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of baseline blood pressure versus post-epileptic seizure blood pressure (systolic and diastolic)	Baseline 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.	within 1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of baseline heart rate versus post-epileptic seizure heart rate	Baseline 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.	within 1 hour
Comparison of baseline blood-oxygen versus post-epileptic seizure blood-oxygen	Baseline 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.	within 1 hour

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing
• Collaborators: The First Affiliated Hospital with Nanjing Medical University; Peking Union Medical College Hospital; First Affiliated Hospital, Sun Yat-Sen University; Beijing Sanbo Brain Hospital; First Affiliated Hospital Xi'an Jiaotong University; The Affiliated Hospital of Qingdao University; First Affiliated Hospital of Zhejiang University; Shandong Provincial Hospital; The First Affiliated Hospital of Zhengzhou University; The First Hospital of Jilin University; Henan Provincial People's Hospital; Fujian Medical University Union Hospital; General Hospital of Ningxia Medical University; The First Hospital of Hebei Medical University; The Affiliated Hospital of Xuzhou Medical University; Shenzhen University General Hospital; Ruijin Hospital Luwan Branch; The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial); Xuanwu Jinan Hospital
• Investigators: Principal Investigator: Liankun Ren, MD, Study Principal Investigator

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2025
• Primary Completion (Actual): March 31, 2026
• Study Completion (Actual): March 31, 2026

Study Registration Dates

• First Submitted: January 18, 2025
• First Submitted That Met QC Criteria: January 18, 2025
• First Posted (Actual): January 24, 2025

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 5, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: epilepsy; blood pressure; Seizures; change; post-seizure; post-epileptic seizure stage
• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Epilepsy; Seizures
• Other Study ID Numbers: 2024-322-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No