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NCT Number: NCT06790810

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

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

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Key information

Age range

14 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Liankun Ren, MD

Beijing, Beijing Municipality, 100053, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Comparison of baseline heart rate versus post-epileptic seizure heart rate

    Time frame: within 1 hour

    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.

  2. Comparison of baseline blood-oxygen versus post-epileptic seizure blood-oxygen

    Time frame: within 1 hour

    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.

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 24, 2025
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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