NCT04950270Completed
Copeptin Kinetics in Critically Ill Patients With Posterior Reversible Encephalopathy Syndrome
The Arginine Vasopressin aXis as a Potential Therapeutic Target for Posterior REverSible Encephalopathy SyndromE (XPRESSE)
Source: ClinicalTrials.gov · Last updated 22 Jul 2024
Brief summary (registry, in English)
XPRESSE is a multicenter observational prospective biomarker study in which critically ill patients with MRI-based PRES diagnosis will have copeptin kinetics from a daily blood sample for 6 days and a 3-month follow-up. This study aims to investigate the relationship between copeptin and PRES in order to establish the optimal therapeutic time window for vaptan treatment against PRES. Data collection using an electronic case report form will include demographic data, medical history and data related to PRES: onset modalities and date of symptoms control, radiological features of PRES, biological investigations, results of etiological investigations and therapeutic management (e.g., anticonvulsants, antihypertensive drugs, supportive treatments). Outcomes will include modified Rankin scale score and Glasgow Outcome Scale score at ICU discharge, 3-month modified Rankin Scale score and 3-month mortality.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 24 (actual)
- First submitted
- 14 Jun 2021
- Start date
- 18 Jun 2022
- Primary completion date
- 26 Feb 2024
- Lead sponsor
- University Hospital, Tours
- NCT number
- NCT04950270
What you commit to
- Study type: Observational
- Participants enrolled: 24
- From 18 Jun 2022 to the primary completion date, 26 Feb 2024
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Patient under legal protection ;
- Patient under guardianship or curatorship
- Pregnant women.
Who the study is looking for
- Age \>= 18 years ;
- Obtaining the non-opposition ;
- Patient hospitalized in ICU;
- PRES diagnosed within the last 48 hours (before admission or during ICU stay), based on the following clinico-radiological criteria :
- Presentation with acute clinical symptoms ;
- Presence of known risk factor for PRES;
- Distributions of T2 weighted imaging (T2WI) or T2-fluid attenuated inversion recovery (T2-FLAIR) hyperintensities compatible with PRES imaging patterns ;
- No other possible causes of these neuroimaging abnormalities found.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| Hospital Coordinator of this site? Confirm its status | Orléans | France | Unknown status |
| University hospital Coordinator of this site? Confirm its status | Rennes | France | Unknown status |
| University hospital Coordinator of this site? Confirm its status | Tours | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.