Intensive Care UnitPrediRAGENCT02070536
Predictive Values of Plasma Soluble RAGE Levels and RAGE Polymorphisms for the Onset of Acute Respiratory Distress Syndrome in Critically Ill Patients
An observational study of Intensive Care Unit and Population at High Risk for ARDS Development, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Current clinical prediction scores for acute respiratory distress syndrome (ARDS) have limited positive predictive value. No studies have evaluated predictive kinetics of plasma biomarkers and receptor for advanced glycation end products (RAGE) polymorphisms in a broad population of critically ill patients or as an… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit, Population at High Risk for ARDS Development
- What is being tested?
- sRAGE
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2014to Dec 2016
- 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: Population at high risk for ARDS development
Who may be able to join
- Patients admitted to the ICU
- Patients presenting with risk factors for ARDS : high risk surgery, sepsis, shock, panceatitis, pneumonia, aspiration, drowning, massive transfusion, pulmonary contusion, serious burn, severe trauma.
- Informed consent
Who cannot join
- Pregnancy
- Age < 18 years
- Criteria for ARDS at admission to the ICU
- Expected survival under 48 hours
Trial locations and contacts
1 site in 1 country.
About this study
Current clinical prediction scores for acute respiratory distress syndrome (ARDS) have limited positive predictive value. No studies have evaluated predictive kinetics of plasma biomarkers and receptor for advanced glycation end products (RAGE) polymorphisms in a broad population of critically ill patients or as an adjunct to clinical prediction scores.
The main objective of the investigators study is to evaluate the predictive values of plasma soluble RAGE levels for the onset of ARDS in a high risk population of patients admitted to the intensive care unit (ICU).
Read more
One of the investigators goals is to improve early identification of patients at risk for ARDS in order to better implement preventive stategies prior to ARDS development.
The primary outcome is the occurrence of ARDS during the first week after admission to the ICU.
Read the detailed description
BACKGROUND :
ARDS is a major cause of morbidity and mortality in critically ill patients. Only few pharmacological treatments are available, with limited evidence of efficacy.
The development of efficient preventive stategies is limited by the investigators inability to predict which patients are likely to develop ARDS. The Lung Injury predicition Score (LIPS) has been developed to identify patients at high risk for ARDS, but its predictive value remains limited.
The receptor for advanced glycation end product (RAGE) is now identified as a marker of alveolar type I cell injury. RAGE is a member of the immunoglobulin superfamily that acts as a multiligand receptor which is involved in propagating inflammatory responses. Plasma levels of sRAGE are correlated with clinical and radiologic severity in ARDS patients.
The investigators main objective is to assess the predictive values of plasma sRAGE and esRAGE levels, as well as their evolution over the first 24 hours after admission, for the onset of ARDS in high risk patients.
The secondary objectives are to :
- to evaluate the predictive value of RAGE polymorphisms (_429 T/C, _374 T/A, 2184 A/G, Gly82Ser) for the onset of ARDS
- to evaluate the predictive value of maximal plasma levels of RAGE soluble forms for the onset of ARDS
- to test the relationship between RAGE polymorphisms and plasma sRAGE and esRAGE levels
- to test whether serial sRAGE measurements would improve the discrimination of the LIP Score or not
- to evaluate the prognostic value of plasma levels of RAGE soluble forms for : duration of mechanical ventilation, length of stay in the ICU and 30-day mortality.
DESIGN NARRATIVE :
The purpose of this prospective observational study is to test the values of RAGE polymorphism and soluble forms plasma levels for ARDS prediction in high risk ICU patients
- Being tested
- sRAGE
- Keywords
- Acute Respiratory Distress Syndrome (ARDS), Receptor for advanced glycation end products (RAGE), Soluble RAGE (sRAGE), Gene polymorphisms, Biomarker
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sRAGEOther
| Study group | Role | What they receive |
|---|---|---|
| ARDS (Acute Respiratory Distress Syndrome) | Not described Receives: Other: sRAGE |
What is being measured
The primary outcome is the main question the study is designed to answer.
development of ARDS
The development of ARDS, based on Berlin definition criteria, during the first week after admission to the ICU
Measured: during the first week after admission to the ICU
Secondary outcomes (7)
Plasma sRAGE and esRAGE levels
Measured: at ICU admission (Day 0)
Plasma sRAGE and esRAGE levels
Measured: (Day 1)
Evolution of plasma sRAGE levels
Measured: between day 0 and day 1
Maximal plasma levels of sRAGE and esRAGE
Measured: during the first 24 hours after ICU admission
Development of ARDS
Measured: during at day 14 and day 30 after ICU admission
Total duration of mechanical ventilation
Measured: at day 1
Length of stay in ICU
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionMar 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intensive Care UnitStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthieu JABAUDON, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02070536
- Sponsor's protocol ID
- CHU-0182
- Acronym
- PrediRAGE
- Status last verified
- Feb 2014
- First submitted
- 21 Feb 2014
- Last updated
- 12 May 2020
- Results posted
- No
Publications
Blondonnet R, Joubert E, Godet T, Berthelin P, Pranal T, Roszyk L, Chabanne R, Eisenmann N, Lautrette A, Belville C, Cayot S, Gillart T, Souweine B, Bouvier D, Blanchon L, Sapin V, Pereira B, Constantin JM, Jabaudon M. Driving pressure and acute respiratory distress syndrome in critically ill patients. Respirology. 2019 Feb;24(2):137-145. doi: 10.1111/resp.13394. Epub 2018 Sep 5.
PubMed 30183115Pranal T, Pereira B, Berthelin P, Roszyk L, Godet T, Chabanne R, Eisenmann N, Lautrette A, Belville C, Blondonnet R, Cayot S, Gillart T, Skrzypczak Y, Souweine B, Bouvier D, Blanchon L, Sapin V, Constantin JM, Jabaudon M. Clinical and Biological Predictors of Plasma Levels of Soluble RAGE in Critically Ill Patients: Secondary Analysis of a Prospective Multicenter Observational Study. Dis Markers. 2018 May 10;2018:7849675. doi: 10.1155/2018/7849675. eCollection 2018.
PubMed 29861796
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Values of Plasma Soluble RAGE Levels and RAGE Polymorphisms for the Onset of Acute Respiratory Distress Syndrome in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT02070536
- Acronym / sponsor ID
- PrediRAGE / CHU-0182
- Keywords
- Acute Respiratory Distress Syndrome (ARDS), Receptor for advanced glycation end products (RAGE), Soluble RAGE (sRAGE), Gene polymorphisms, Biomarker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 25 Feb 2014 (estimated)
- 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.
Current clinical prediction scores for acute respiratory distress syndrome (ARDS) have limited positive predictive value. No studies have evaluated predictive kinetics of plasma biomarkers and receptor for advanced glycation end products (RAGE) polymorphisms in a broad population of critically ill patients or as an adjunct to clinical prediction scores.
The main objective of the investigators study is to evaluate the predictive values of plasma soluble RAGE levels for the onset of ARDS in a high risk population of patients admitted to the intensive care unit (ICU).
One of the investigators goals is to improve early identification of patients at risk for ARDS in order to better implement preventive stategies prior to ARDS development.
The primary outcome is the occurrence of ARDS during the first week after admission to the ICU.
Detailed description
BACKGROUND :
ARDS is a major cause of morbidity and mortality in critically ill patients. Only few pharmacological treatments are available, with limited evidence of efficacy.
The development of efficient preventive stategies is limited by the investigators inability to predict which patients are likely to develop ARDS. The Lung Injury predicition Score (LIPS) has been developed to identify patients at high risk for ARDS, but its predictive value remains limited.
The receptor for advanced glycation end product (RAGE) is now identified as a marker of alveolar type I cell injury. RAGE is a member of the immunoglobulin superfamily that acts as a multiligand receptor which is involved in propagating inflammatory responses. Plasma levels of sRAGE are correlated with clinical and radiologic severity in ARDS patients.
The investigators main objective is to assess the predictive values of plasma sRAGE and esRAGE levels, as well as their evolution over the first 24 hours after admission, for the onset of ARDS in high risk patients.
The secondary objectives are to :
- to evaluate the predictive value of RAGE polymorphisms (_429 T/C, _374 T/A, 2184 A/G, Gly82Ser) for the onset of ARDS
- to evaluate the predictive value of maximal plasma levels of RAGE soluble forms for the onset of ARDS
- to test the relationship between RAGE polymorphisms and plasma sRAGE and esRAGE levels
- to test whether serial sRAGE measurements would improve the discrimination of the LIP Score or not
- to evaluate the prognostic value of plasma levels of RAGE soluble forms for : duration of mechanical ventilation, length of stay in the ICU and 30-day mortality.
DESIGN NARRATIVE :
The purpose of this prospective observational study is to test the values of RAGE polymorphism and soluble forms plasma levels for ARDS prediction in high risk ICU patients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARDS (Acute Respiratory Distress Syndrome) | – | Other: sRAGE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population at high risk for ARDS development
Key inclusion criteria (3 listed)
- Patients admitted to the ICU
- Patients presenting with risk factors for ARDS : high risk surgery, sepsis, shock, panceatitis, pneumonia, aspiration, drowning, massive transfusion, pulmonary contusion, serious burn, severe trauma.
- Informed consent
Key exclusion criteria (4 listed)
- Pregnancy
- Age < 18 years
- Criteria for ARDS at admission to the ICU
- Expected survival under 48 hours
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 |
|---|---|---|
| sRAGE | Other | ARDS (Acute Respiratory Distress Syndrome) |
Primary outcome
development of ARDS
Time frame: during the first week after admission to the ICU
The development of ARDS, based on Berlin definition criteria, during the first week after admission to the ICU
7 secondary outcomes
Plasma sRAGE and esRAGE levels
Time frame: at ICU admission (Day 0)
Plasma sRAGE and esRAGE levels
Time frame: (Day 1)
Evolution of plasma sRAGE levels
Time frame: between day 0 and day 1
Maximal plasma levels of sRAGE and esRAGE
Time frame: during the first 24 hours after ICU admission
Development of ARDS
Time frame: during at day 14 and day 30 after ICU admission
Total duration of mechanical ventilation
Time frame: at day 1
Length of stay in ICU
Time frame: at day 1
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 12 May 2020.
- Derived from this study: PubMed 30183115Blondonnet R, Joubert E, Godet T, Berthelin P, Pranal T, Roszyk L, Chabanne R, Eisenmann N, Lautrette A, Belville C, Cayot S, Gillart T, Souweine B, Bouvier D, Blanchon L, Sapin V, Pereira B, Constantin JM, Jabaudon M. Driving pressure and acute respiratory distress syndrome in critically ill patients. Respirology. 2019 Feb;24(2):137-145. doi: 10.1111/resp.13394. Epub 2018 Sep 5.
- Derived from this study: PubMed 29861796Pranal T, Pereira B, Berthelin P, Roszyk L, Godet T, Chabanne R, Eisenmann N, Lautrette A, Belville C, Blondonnet R, Cayot S, Gillart T, Skrzypczak Y, Souweine B, Bouvier D, Blanchon L, Sapin V, Constantin JM, Jabaudon M. Clinical and Biological Predictors of Plasma Levels of Soluble RAGE in Critically Ill Patients: Secondary Analysis of a Prospective Multicenter Observational Study. Dis Markers. 2018 May 10;2018:7849675. doi: 10.1155/2018/7849675. eCollection 2018.
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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.
Matthieu JABAUDON principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care Unit and Population at High Risk for ARDS Development, run by University Hospital, Clermont-Ferrand at 1 site 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 3 inclusion and 4 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 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
development of ARDS (time frame: during the first week after admission to the ICU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02070536, which also lists 2 linked publications.
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 12 May 2020.