Epilepsy; SeizureNCT06790810
Observational Study on Dynamic Changes of Blood Pressure During Post-epileptic Seizure Stage (OCBPS)
An observational study of Epilepsy; Seizure and Blood Pressure, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
This article details a multicenter study on changes of blood pressure and heart rate during post-epileptic seizure stage. Read more about this study
- Who is it for?
- Ages 14 to 80 years
- Conditions the study is for
- Epilepsy; Seizure, Blood Pressure
- How many people
- 1,100 participants
- Where
- 1 siteChina
- Study dates
- 26 Jan 2025to 31 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Inpatient epilepsy patients
Who may be able to join
- 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.
Who cannot join
- Patients with structural heart disease, coronary artery disease (CAD), cardiomyopathy
- Patients with severe systemic diseases
- Pregnancy
- Preictal seizures or myoclonic seizures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Epilepsy; Seizure, Blood Pressure
- Keywords
- Seizures, epilepsy, blood pressure, change, post-seizure, post-epileptic seizure stage
- Medical subject headings
- Epilepsy, Seizures
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 1 hour
Secondary outcomes (2)
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.
Measured: 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.
Measured: within 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start26 Jan 2025
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy; SeizureStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- Fujian Medical University Union Hospital, The First Hospital of Hebei Medical University, Henan Provincial People's Hospital, The First Hospital of Jilin University, The First Affiliated Hospital with Nanjing Medical University, General Hospital of Ningxia Medical University, The Affiliated Hospital of Qingdao University, Shandong Provincial Hospital, Ruijin Hospital Luwan Branch, Shenzhen University General Hospital, Beijing Sanbo Brain Hospital, Xuanwu Jinan Hospital, First Affiliated Hospital Xi'an Jiaotong University, The Affiliated Hospital of Xuzhou Medical University, First Affiliated Hospital of Zhejiang University, The First Affiliated Hospital of Zhengzhou University, The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial), Peking Union Medical College Hospital, First Affiliated Hospital, Sun Yat-Sen University
- Responsible party
- Principal investigator, Liankun_Ren, Xuanwu Hospital, Beijing
- Investigators
- Liankun Ren, MD, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06790810
- Sponsor's protocol ID
- 2024-322-002
- Status last verified
- Apr 2026
- First submitted
- 18 Jan 2025
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on Dynamic Changes of Blood Pressure During Post-epileptic Seizure Stage: A Multicenter Study
- ClinicalTrials.gov ID
- NCT06790810
- Acronym / sponsor ID
- 2024-322-002
- Conditions
- Epilepsy; Seizure, Blood Pressure
- Keywords
- Seizures, epilepsy, blood pressure, change, post-seizure, post-epileptic seizure stage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,100 participants (actual)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Collaborators
- Fujian Medical University Union Hospital, The First Hospital of Hebei Medical University, Henan Provincial People's Hospital, The First Hospital of Jilin University, The First Affiliated Hospital with Nanjing Medical University, General Hospital of Ningxia Medical University, The Affiliated Hospital of Qingdao University, Shandong Provincial Hospital, Ruijin Hospital Luwan Branch, Shenzhen University General Hospital, Beijing Sanbo Brain Hospital, Xuanwu Jinan Hospital, First Affiliated Hospital Xi'an Jiaotong University, The Affiliated Hospital of Xuzhou Medical University, First Affiliated Hospital of Zhejiang University, The First Affiliated Hospital of Zhengzhou University, The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial), Peking Union Medical College Hospital, First Affiliated Hospital, Sun Yat-Sen University
- Study start
- 26 Jan 2025 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 24 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Inpatient epilepsy patients
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- Patients with structural heart disease, coronary artery disease (CAD), cardiomyopathy
- Patients with severe systemic diseases
- Pregnancy
- Preictal seizures or myoclonic seizures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of baseline blood pressure versus post-epileptic seizure blood pressure (systolic and diastolic)
Time frame: within 1 hour
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.
2 secondary outcomes
Comparison of baseline heart rate versus post-epileptic seizure heart rate
Time frame: within 1 hour
Comparison of baseline blood-oxygen versus post-epileptic seizure blood-oxygen
Time frame: within 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liankun Ren, MD principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy; Seizure and Blood Pressure, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of baseline blood pressure versus post-epileptic seizure blood pressure (systolic and diastolic) (time frame: within 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.