Posterior Reversible Encephalopathy SyndromeNCT05310513
The Predictors of ICU Admission of oPRES
An observational study of Posterior Reversible Encephalopathy Syndrome and Intensive Care Units, run by Dunjin Chen at 1 site in China.
Trial summary
The purpose of this study is to explore the predictors of ICU admission of obstetric posterior reversible encephalopathy syndrome. Read more about this study
- Who is it for?
- Ages 16 to 50 years, women only
- Conditions the study is for
- Posterior Reversible Encephalopathy Syndrome, Intensive Care Units
- What is being tested?
- Whether the patient needs to be admitted to the ICU
- How many people
- 366 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2022to 31 May 2022
- 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 16 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Pregnant Women diagnosed with PRES
Who may be able to join
- Pregnant Women were diagnosed of PRES.
- all patients provided written informed consent
Who cannot join
- patients combined with other neurological disorders
- patients combined with mental illness
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Obstetrics and Gynecology, Key Laboratory for Major Obstetric Diseases of Guangdong Province, The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, 510150
About this study
Official title: The Predictors of ICU Admission of Obstetric Posterion Reversible Encephalopathy Syndrome
The purpose of this study is to explore the predictors of ICU admission of obstetric posterior reversible encephalopathy syndrome.
Read the detailed description
The investigators retrospectively collected data (General information, clinical data, biochemical indicators, imaging features, and pregnancy outcome) from pregnant woman diagnosed with PRES to explore the predictors of ICU admission during 2012 to 2021.Then, the investigators grouped all the patients into ICU group and Non-ICU group according to ICU admission or not.
- Being tested
- Whether the patient needs to be admitted to the ICU
- Medical subject headings
- Posterior Leukoencephalopathy Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whether the patient needs to be admitted to the ICUOther
According to ICU admission or not, patients were grouped into ICU group and NOT-ICU group.
| Study group | Role | What they receive |
|---|---|---|
| ICU group | patients admitted to ICU with PRES. Receives: Other: Whether the patient needs to be admitted to the ICU | |
| Non-ICU group | patients not admitted to ICU with PRES. Receives: Other: Whether the patient needs to be admitted to the ICU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure(BP)
blood pressure including systolic blood pressure (SBP), and diastolic blood pressure (DBP).
Measured: The BP of patients was obtained immediately at the onset of symptoms.
severity of the edema
The extent and severity of the edema observed in the lesion area were graded on a scale of 0-5 by evaluating FLAIR images.(0, normal; 1, limited cortical or subcortical white matter oedema; 2, white matter oedema > cortical oedema, white matter oedema extending into deep white matter; 3, white matter oedema > cortex oedema, oedema extending to the ventricular surface; 4, the involved regions substantially extend to the ventricular surface and are almost com- pletely confluent; 5, involved regions are fully confluent and con- tinuous, ventricular deformity due to the oedema).
Measured: Cranial Imaging was examined immediately at the onset of symptoms, such as s headaches, visual changes, seizures, consciousness impairment.
pregnancy outcomes
The rates of stillbirth and premature birth (gestation less than 37 weeks) in PRES patients.
Measured: The pregnancy outcomes will record immediately when the patients deliver.
biochemical parameters
The level of lactate dehydrogenase(LDH) will be measured，and LDH﹥380U/L means a worse outcome.
Measured: Biochemical indicators were collected within 1 week of the hospital stay.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start1 Apr 2022
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posterior Reversible Encephalopathy SyndromeStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 366 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dunjin Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dunjin Chen, Guangzhou Medical University
- Investigators
- Dunjin Chen, Principal investigator, The Third Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05310513
- Sponsor's protocol ID
- 2019A151510102
- Status last verified
- Mar 2022
- First submitted
- 15 Mar 2022
- Last updated
- 14 Jun 2022
- Results posted
- No
- 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 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictors of ICU Admission of Obstetric Posterion Reversible Encephalopathy Syndrome
- ClinicalTrials.gov ID
- NCT05310513
- Acronym / sponsor ID
- 2019A151510102
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 366 participants (actual)
- Lead sponsor
- Dunjin ChenUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 5 Apr 2022 (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.
The purpose of this study is to explore the predictors of ICU admission of obstetric posterior reversible encephalopathy syndrome.
Detailed description
The investigators retrospectively collected data (General information, clinical data, biochemical indicators, imaging features, and pregnancy outcome) from pregnant woman diagnosed with PRES to explore the predictors of ICU admission during 2012 to 2021.Then, the investigators grouped all the patients into ICU group and Non-ICU group according to ICU admission or not.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICU group | – | Other: Whether the patient needs to be admitted to the ICUpatients admitted to ICU with PRES. |
| Non-ICU group | – | Other: Whether the patient needs to be admitted to the ICUpatients not admitted to ICU with PRES. |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pregnant Women diagnosed with PRES
Key inclusion criteria (2 listed)
- Pregnant Women were diagnosed of PRES.
- all patients provided written informed consent
Key exclusion criteria (2 listed)
- patients combined with other neurological disorders
- patients combined with mental illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whether the patient needs to be admitted to the ICUAccording to ICU admission or not, patients were grouped into ICU group and NOT-ICU group. | Other | ICU group, Non-ICU group |
Primary outcome
Blood Pressure(BP)
Time frame: The BP of patients was obtained immediately at the onset of symptoms.
blood pressure including systolic blood pressure (SBP), and diastolic blood pressure (DBP).
severity of the edema
Time frame: Cranial Imaging was examined immediately at the onset of symptoms, such as s headaches, visual changes, seizures, consciousness impairment.
The extent and severity of the edema observed in the lesion area were graded on a scale of 0-5 by evaluating FLAIR images.(0, normal; 1, limited cortical or subcortical white matter oedema; 2, white matter oedema > cortical oedema, white matter oedema extending into deep white matter; 3, white matter oedema > cortex oedema, oedema extending to the ventricular surface; 4, the involved regions substantially extend to the ventricular surface and are almost com- pletely confluent; 5, involved regions are fully confluent and con- tinuous, ventricular deformity due to the oedema).
pregnancy outcomes
Time frame: The pregnancy outcomes will record immediately when the patients deliver.
The rates of stillbirth and premature birth (gestation less than 37 weeks) in PRES patients.
biochemical parameters
Time frame: Biochemical indicators were collected within 1 week of the hospital stay.
The level of lactate dehydrogenase(LDH) will be measured，and LDH﹥380U/L means a worse outcome.
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 14 Jun 2022.
- Individual participant dataSharing planned: No
Related trials for Posterior Reversible Encephalopathy Syndrome
RecruitingObservational study
Posterior Reversible Encephalopathy Syndrome in the Critically Ill Patients
Posterior Reversible Encephalopathy Syndrome
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.
Dunjin Chen principal investigator
The Third Affiliated Hospital of Guangzhou Medical University
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 Posterior Reversible Encephalopathy Syndrome and Intensive Care Units, run by Dunjin Chen 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 2 inclusion and 2 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 14 Jun 2022. 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?
Blood Pressure(BP) (time frame: The BP of patients was obtained immediately at the onset of symptoms.). The study lists 4 primary outcomes in all. 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 14 Jun 2022.