Copeptin Kinetics in Critically Ill Patients With Posterior Reversible Encephalopathy Syndrome

NCT ID: NCT04950270

Last Updated: 2024-07-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 24 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-18
• Study Completion Date: 2024-02-26

Brief Summary

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.

Detailed Description

Posterior reversible encephalopathy syndrome (PRES) is a clinical and radiological entity associating various neurological manifestations (e.g., encephalopathy, seizures) with a typical subcortical brain edema. While the pathophysiology of PRES remains elusive, the involvement of the arginine vasopressin (AVP) axis has recently been suggested by its stimulation in almost all etiologies of PRES as well as by its pathogenesis in the generation of brain edema that has been established in different preclinical models (e.g., traumatic brain injury, intracerebral hemorrhage) (Largeau et al., Mol Neurobiol 2019 - PMID: 30924075). Copeptin, a stable peptide derived from the same precursor as AVP and released in an equimolar ratio to AVP, is largely used in vivo to monitor AVP secretion. In a series of 225 critically ill patients free from PRES, median copeptin admission level was 50 pmol/L (Krychtiuk et al., PLOS ONE 2017- PMID: 28118414). By analogy to copeptin kinetics in patients with traumatic brain injury (Dong et al., J Trauma 2011 - PMID: 21502880), copeptin could attain peak level during the first week of PRES.

Blocking vasopressin receptors with vaptan appears to be a promising approach for PRES treatment. 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.

XPRESSE is a multicenter observational prospective biomarker study in which critically ill patients in 4 French ICUs with MRI-based PRES diagnosis will have copeptin kinetics from a daily blood sample for 6 days and a 3-month follow-up.

Data collection using an eCRF 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.

Conditions

Posterior Reversible Encephalopathy Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group

Critically ill adult patients meeting all eligibility criteria with MRI-based PRES diagnosis within the last 48 hours

Blood copeptin monitoring

Intervention Type: BIOLOGICAL

Blood copeptin monitoring during the first 6 days of ICU stay with PRES

phone interview

Intervention Type: OTHER

Structured phone interview at 3 months to collect vital status and modified Rankin Scale score

Interventions

Blood copeptin monitoring

Blood copeptin monitoring during the first 6 days of ICU stay with PRES

Intervention Type: BIOLOGICAL

phone interview

Structured phone interview at 3 months to collect vital status and modified Rankin Scale score

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• Patient under legal protection ;
• Patient under guardianship or curatorship
• Pregnant women.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Tours

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bérenger LARGEAU, PharmD

Role: STUDY_CHAIR

University Hospital, Tours

Charlotte SALMON GANDONNIERE, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Tours

Locations

University hospital

Nantes, , France

Hospital

Orléans, , France

University hospital

Rennes, , France

University hospital

Tours, , France

Countries

France

Other Identifiers

RIPH3-AOJCE20-BL-XPRESSE

Identifier Type: -

Identifier Source: org_study_id