Posterior Reversible Encephalopathy SyndromeXPRESSENCT04950270
Copeptin Kinetics in Critically Ill Patients With Posterior Reversible Encephalopathy Syndrome
An observational study of Posterior Reversible Encephalopathy Syndrome, run by University Hospital, Tours at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posterior Reversible Encephalopathy Syndrome
- What is being tested?
- Blood copeptin monitoring and phone interview
- How many people
- 24 participants
- Where
- 4 sitesFrance
- Study dates
- 18 Jun 2022to 26 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill adult patients in ICU with PRES
Who may be able to join
- 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.
Who cannot join
- Patient under legal protection ;
- Patient under guardianship or curatorship
- Pregnant women.
Trial locations and contacts
4 sites in 1 country.
France4 sites
University hospital
Nantes, 44000
Hospital
Orléans, 45000
University hospital
Rennes, 35033
University hospital
Tours, 37000
About this study
Official 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.
Read the 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.
- Being tested
- Blood copeptin monitoring, phone interview
- Keywords
- Posterior Leukoencephalopathy Syndrome, Antidiuretic hormone, Intensive Care
- Medical subject headings
- Posterior Leukoencephalopathy Syndrome, Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood copeptin monitoringBiological
Blood copeptin monitoring during the first 6 days of ICU stay with PRES
phone interviewOther
Structured phone interview at 3 months to collect vital status and modified Rankin Scale score
| Study group | Role | What they receive |
|---|---|---|
| Group | Critically ill adult patients meeting all eligibility criteria with MRI-based PRES diagnosis within the last 48 hours Receives: Biological: Blood copeptin monitoring; Other: phone interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 120 hours post-baseline
Secondary outcomes (15)
Estimation of Tmax according to the etiology of PRES
Measured: Up to 120 hours post-baseline
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
Measured: 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
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
Measured: 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
DWI sequences and ADC maps will be used to discriminate a cytotoxic pattern of edema from a vasogenic edema
Measured: Up to 120 hours post-baseline
Estimation of time to reach a copeptin concentration ≤50 pmol/L according to the etiology of PRES
Measured: Up to 120 hours post-baseline
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
Measured: Up to 120 hours post-baseline
Correlation analysis between AUC D0-D5 of blood copeptin and the extent of T2-FLAIR hyperintensities at diagnosis
Measured: Up to 120 hours post-baseline
Correlation analysis between AUC D0-D5 of blood copeptin and ADC values at diagnosis
Measured: Up to 120 hours post-baseline
Association analysis between AUC D0-D5 of blood copeptin and cerebral hemorrhagic lesions at diagnosis
Measured: Up to 120 hours post-baseline
Association analysis between AUC D0-D5 of blood copeptin and contrast enhancement in the brain at diagnosis
Measured: Up to 120 hours post-baseline
Correlation analysis between AUC D0-D5 of blood copeptin and AUC D0-D5 of mean arterial pressure
Measured: Up to 120 hours post-baseline
Correlation analysis between AUC D0-D5 of blood copeptin and AUC D0-D5 of serum creatinine
Measured: Up to 120 hours post-baseline
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]
Measured: 0, 24, 48, 72, 96, 120 hours post-baseline and ICU discharge
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]
Measured: 0, 24, 48, 72, 96, 120 hours post-baseline and 3 months
Association analysis between AUC D0-D5 of blood copeptin and mortality at 3-month follow-up
Measured: 0, 24, 48, 72, 96, 120 hours post-baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start18 Jun 2022
- Primary completion26 Feb 2024
- Study completion26 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posterior Reversible Encephalopathy SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bérenger LARGEAU, PharmD, Study chair, University Hospital, ToursCharlotte SALMON GANDONNIERE, MD, PhD, Principal investigator, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04950270
- Sponsor's protocol ID
- RIPH3-AOJCE20-BL-XPRESSE
- Acronym
- XPRESSE
- Status last verified
- Jul 2024
- First submitted
- 14 Jun 2021
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Arginine Vasopressin aXis as a Potential Therapeutic Target for Posterior REverSible Encephalopathy SyndromE (XPRESSE)
- ClinicalTrials.gov ID
- NCT04950270
- Acronym / sponsor ID
- XPRESSE / RIPH3-AOJCE20-BL-XPRESSE
- Keywords
- Posterior Leukoencephalopathy Syndrome, Antidiuretic hormone, Intensive Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 18 Jun 2022 (actual)
- Primary completion
- 26 Feb 2024 (actual)
- Study completion
- 26 Feb 2024 (actual)
- First posted
- 6 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group | – | Biological: Blood copeptin monitoring, Other: phone interviewCritically ill adult patients meeting all eligibility criteria with MRI-based PRES diagnosis within the last 48 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill adult patients in ICU with PRES
Key inclusion criteria (8 listed)
- 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 :
Key exclusion criteria (3 listed)
- Patient under legal protection ;
- Patient under guardianship or curatorship
- Pregnant women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood copeptin monitoringBlood copeptin monitoring during the first 6 days of ICU stay with PRES | Biological | Group |
| phone interviewStructured phone interview at 3 months to collect vital status and modified Rankin Scale score | Other | Group |
Primary outcome
Estimation of time to maximum blood copeptin concentration (Tmax)
Time frame: Up to 120 hours post-baseline
Tmax will be estimated from copeptin kinetics: 6 samples at about 24 hours interval during the first 6 days of ICU stay with PRES
15 secondary outcomes
Estimation of Tmax according to the etiology of PRES
Time frame: Up to 120 hours post-baseline
Estimation of Tmax according to the type of MRI-based brain edema at diagnosis
Time frame: 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
Time frame: 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
Time frame: Up to 120 hours post-baseline
Estimation of time to reach a copeptin concentration ≤50 pmol/L according to the etiology of PRES
Time frame: Up to 120 hours post-baseline
Estimation of time to reach a copeptin concentration ≤50 pmol/L according to the type of MRI-based brain edema at diagnosis
Time frame: Up to 120 hours post-baseline
Correlation analysis between AUC D0-D5 of blood copeptin and the extent of T2-FLAIR hyperintensities at diagnosis
Time frame: Up to 120 hours post-baseline
Correlation analysis between AUC D0-D5 of blood copeptin and ADC values at diagnosis
Time frame: Up to 120 hours post-baseline
Association analysis between AUC D0-D5 of blood copeptin and cerebral hemorrhagic lesions at diagnosis
Time frame: Up to 120 hours post-baseline
Association analysis between AUC D0-D5 of blood copeptin and contrast enhancement in the brain at diagnosis
Time frame: Up to 120 hours post-baseline
Correlation analysis between AUC D0-D5 of blood copeptin and AUC D0-D5 of mean arterial pressure
Time frame: Up to 120 hours post-baseline
Correlation analysis between AUC D0-D5 of blood copeptin and AUC D0-D5 of serum creatinine
Time frame: Up to 120 hours post-baseline
Association analysis between AUC D0-D5 of blood copeptin and Glasgow Outcome Scale score < 4 at ICU discharge
Time frame: 0, 24, 48, 72, 96, 120 hours post-baseline and ICU discharge
Association analysis between AUC D0-D5 of blood copeptin and modified Rankin Scale score ≥ 4 at 3-month follow-up
Time frame: 0, 24, 48, 72, 96, 120 hours post-baseline and 3 months
Association analysis between AUC D0-D5 of blood copeptin and mortality at 3-month follow-up
Time frame: 0, 24, 48, 72, 96, 120 hours post-baseline and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Posterior Reversible Encephalopathy Syndrome
RecruitingObservational study
Posterior Reversible Encephalopathy Syndrome in the Critically Ill Patients
Posterior Reversible Encephalopathy Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bérenger LARGEAU, PharmD study chair
University Hospital, Tours
Charlotte SALMON GANDONNIERE, MD, PhD principal investigator
University Hospital, Tours
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Posterior Reversible Encephalopathy Syndrome, run by University Hospital, Tours at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimation of time to maximum blood copeptin concentration (Tmax) (time frame: Up to 120 hours post-baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2024.