The Predictors of ICU Admission of oPRES

Completed

• Conditions: Intensive Care Units; Posterior Reversible Encephalopathy Syndrome
• Interventions: Other: Whether the patient needs to be admitted to the ICU

• Registration Number: NCT05310513
• Lead Sponsor: Dunjin Chen

Brief Summary

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 Timeline

• Status Verified: 2022-03
• Study First Submitted: 2022-03-15
• Study First Submitted QC: 2022-03-25
• Study Start: 2022-04-01
• Study First Posted: 2022-04-05
• Primary Completion: 2022-05-31
• Study Completion: 2022-05-31
• Last Update Submitted: 2022-06-11
• Last Update Posted: 2022-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 366

Inclusion Criteria

1. Pregnant Women were diagnosed of PRES.
2. all patients provided written informed consent

Exclusion Criteria

1. patients combined with other neurological disorders
2. patients combined with mental illness

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-ICU group	Whether the patient needs to be admitted to the ICU	patients not admitted to ICU with PRES.
ICU group	Whether the patient needs to be admitted to the ICU	patients admitted to ICU with PRES.

Primary Outcome Measures

Name	Time	Method
severity of the edema	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).
Blood Pressure(BP)	The BP of patients was obtained immediately at the onset of symptoms.	blood pressure including systolic blood pressure (SBP), and diastolic blood pressure (DBP).
pregnancy outcomes	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	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.

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, Key Laboratory for Major Obstetric Diseases of Guangdong Province, The Third Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, China