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

NCT06790810 | Completed DMC

• 1 other identifier: 2024-322-002
• Study Type: observational
• Target: 1,100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Epilepsy; Seizure; Blood Pressure

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Comparison of baseline heart rate versus post-epileptic seizure heart rate

  within 1 hour

• Comparison of baseline blood-oxygen versus post-epileptic seizure blood-oxygen

  within 1 hour

Eligibility Criteria

• Age: 14 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Inpatient epilepsy patients

You may qualify if:

• Age 14-80 years old, male and female;
• Meet the diagnostic criteria for epilepsy, including focal epilepsy and generalized epilepsy.
• Patients diagnosed with epilepsy, with at least one seizure during the hospitalization.
• 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).
• Hypertensive patients who are on antihypertensive medication and have well-controlled blood pressure are eligible.
• Patients who agree to participate in the study.

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Liankun Ren, MD

Beijing, Beijing Municipality, 100053, China

Location

MeSH Terms

Conditions

Epilepsy; Seizures

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Liankun Ren, MD

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 18, 2025
• First Posted: January 24, 2025
• Study Start: January 26, 2025
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)