Copeptin Kinetics in Critically Ill Patients With Posterior Reversible Encephalopathy Syndrome

NCT04950270 | Completed

• 1 other identifier: RIPH3-AOJCE20-BL-XPRESSE
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 4

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.

Conditions

Posterior Reversible Encephalopathy Syndrome

Keywords

Posterior Leukoencephalopathy Syndrome; Antidiuretic hormone; Intensive Care

Outcome Measures

Primary Outcomes (1)

• Estimation of time to maximum blood copeptin concentration (Tmax)

  Tmax will be estimated from copeptin kinetics: 6 samples at about 24 hours interval during the first 6 days of ICU stay with PRES

  Up to 120 hours post-baseline

Secondary Outcomes (15)

• Estimation of Tmax according to the etiology of PRES

  Up to 120 hours post-baseline

• Estimation of Tmax according to the type of MRI-based brain edema at diagnosis

  Up to 120 hours post-baseline

• Estimation of Area Under the Curve from D0 to D5 (AUC D0-D5) of blood copeptin according to the etiology of PRES

  Up to 120 hours post-baseline

• Estimation of AUC D0-D5 of blood copeptin according to the type of MRI-based brain edema at diagnosis

  Up to 120 hours post-baseline

• Estimation of time to reach a copeptin concentration ≤50 pmol/L according to the etiology of PRES

  Up to 120 hours post-baseline

Study Arms (1)

Group

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

Biological: Blood copeptin monitoring; Other: phone interview

Interventions

Blood copeptin monitoring BIOLOGICAL

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

Group

phone interview OTHER

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

Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically ill adult patients in ICU with PRES

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (4)

University hospital

Nantes, 44000, France

Location

Hospital

Orléans, 45000, France

Location

University hospital

Rennes, 35033, France

Location

University hospital

Tours, 37000, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample

MeSH Terms

Conditions

Posterior Leukoencephalopathy Syndrome; Diabetes Insipidus

Condition Hierarchy (Ancestors)

Hypertensive Encephalopathy; Intracranial Hypertension; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Leukoencephalopathies; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases

Study Officials

• Bérenger LARGEAU, PharmD

  University Hospital, Tours

  STUDY CHAIR

• Charlotte SALMON GANDONNIERE, MD, PhD

  University Hospital, Tours

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: July 6, 2021
• Study Start: June 18, 2022
• Primary Completion: February 26, 2024
• Study Completion: February 26, 2024
• Last Updated: July 22, 2024

Record last verified: 2024-07

Locations

FR (4)