Posterior Reversible Encephalopathy Syndrome Clinical Trial
— XPRESSEOfficial title:
The Arginine Vasopressin aXis as a Potential Therapeutic Target for Posterior REverSible Encephalopathy SyndromE (XPRESSE)
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 | Recruiting |
Enrollment | 24 |
Est. completion date | June 2025 |
Est. primary completion date | June 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
France | University hospital | Nantes | |
France | Hospital | Orléans | |
France | University hospital | Rennes | |
France | University hospital | Tours |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Tours |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Estimation of Tmax according to the etiology of PRES | Up to 120 hours post-baseline | ||
Secondary | Estimation of Tmax according to the type of MRI-based brain edema at diagnosis | Diffusion-weighted imaging (DWI) sequences and Apparent diffusion coefficient (ADC) maps will be used to discriminate a cytotoxic pattern of edema from a vasogenic edema | Up to 120 hours post-baseline | |
Secondary | Estimation of Area Under the Curve from D0 to D5 (AUC D0-D5) of blood copeptin according to the etiology of PRES | AUC D0-D5 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 | Estimation of AUC D0-D5 of blood copeptin according to the type of MRI-based brain edema at diagnosis | DWI sequences and ADC maps will be used to discriminate a cytotoxic pattern of edema from a vasogenic edema | Up to 120 hours post-baseline | |
Secondary | Estimation of time to reach a copeptin concentration =50 pmol/L according to the etiology of PRES | Up to 120 hours post-baseline | ||
Secondary | Estimation of time to reach a copeptin concentration =50 pmol/L according to the type of MRI-based brain edema at diagnosis | DWI sequences and ADC maps will be used to discriminate a cytotoxic pattern of edema from a vasogenic edema | Up to 120 hours post-baseline | |
Secondary | Correlation analysis between AUC D0-D5 of blood copeptin and the extent of T2-FLAIR hyperintensities at diagnosis | Up to 120 hours post-baseline | ||
Secondary | Correlation analysis between AUC D0-D5 of blood copeptin and ADC values at diagnosis | Up to 120 hours post-baseline | ||
Secondary | Association analysis between AUC D0-D5 of blood copeptin and cerebral hemorrhagic lesions at diagnosis | Up to 120 hours post-baseline | ||
Secondary | Association analysis between AUC D0-D5 of blood copeptin and contrast enhancement in the brain at diagnosis | Up to 120 hours post-baseline | ||
Secondary | Correlation analysis between AUC D0-D5 of blood copeptin and AUC D0-D5 of mean arterial pressure | Up to 120 hours post-baseline | ||
Secondary | Correlation analysis between AUC D0-D5 of blood copeptin and AUC D0-D5 of serum creatinine | Up to 120 hours post-baseline | ||
Secondary | Association analysis between AUC D0-D5 of blood copeptin and Glasgow Outcome Scale score < 4 at ICU discharge | Glasgow Outcome Scale score: [1: Death, 2: Persistent vegetative state, 3: Severe disability, 4: Moderate disability, 5: Low disability] | 0, 24, 48, 72, 96, 120 hours post-baseline and ICU discharge | |
Secondary | Association analysis between AUC D0-D5 of blood copeptin and modified Rankin Scale score = 4 at 3-month follow-up | Day-90 modified Rankin scale will be determined during a structured phone interview.
Modified Rankin Scale score: [0: No symptoms at all, 1: No significant disability, 2: Slight disability, 3: Moderate disability, 4: Moderately severe disability, 5: Severe disability] |
0, 24, 48, 72, 96, 120 hours post-baseline and 3 months | |
Secondary | Association analysis between AUC D0-D5 of blood copeptin and mortality at 3-month follow-up | 0, 24, 48, 72, 96, 120 hours post-baseline and 3 months |
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