Acute Lung InjuryNCT00811629
Influence of Acute Respiratory Distress Syndrome (ARDS) and Severe Sepsis on sRAGE Levels in ICU Patients
An observational study of Acute Lung Injury and Acute Respiratory Distress Syndrome, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
sRAGE, the soluble form of the receptor for advanced glycation end products, is a novel marker of alveolar epithelial type I cell injury, but is also involved in acute systemic inflammation. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Acute Lung Injury, Acute Respiratory Distress Syndrome, Severe Sepsis
- What is being tested?
- sRAGE
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2009to Jul 2009
- 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Definied population
Who may be able to join
- ICU patients under mechanical ventilation
- Patients within the first 24 hours after onset of ALI/ARDS according to the 1994 American-European Consensus Conference (AECC)
- Patients within the first 24 hours after onset of severe sepsis or septic shock according to the 1992 ACCP/SCCM Consensus Conference
Who cannot join
- Pregnancy
- Acute exacerbation of diabetes
- Dialysis for end-stage kidney disease
- Alzheimer's disease
- Amyloidosis
- Evolutive neoplastic lesion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Soluble Form of the Receptor for Advanced Glycation End Products (sRAGE) Levels in the Pulmonary Edema Fluid and Plasma From ICU Patients With ALI/ARDS and Severe Sepsis : an Observational Prospective Study.
sRAGE, the soluble form of the receptor for advanced glycation end products, is a novel marker of alveolar epithelial type I cell injury, but is also involved in acute systemic inflammation. The purpose of this observational prospective study is to determine whether sRAGE could be used in an ICU setting as a potential diagnostic and prognostic marker during ALI/ARDS, regardless of associated severe sepsis or septic shock.
Read the detailed description
BACKGROUND:
The receptor for advanced glycation end products (RAGE was recently identified as a promising new marker of alveolar type I cell injury. RAGE is a member of the immunoglobulin superfamily that acts as a multiligand receptor and is involved in propagating inflammatory responses. While the precise function of RAGE remains unclear, the elevated levels of RAGE, and its soluble isoform sRAGE, correlate with severity of ALI/ARDS in human and animal studies, and RAGE levels could reflect impaired alveolar fluid clearance. Thus, it is possible that elevated levels of RAGE in ALI/ARDS derive in part from RAGE's role in systemic inflammatory cascades rather than purely from its release from alveolar type I cells.
DESIGN NARRATIVE:
This observational prospective clinical study will describe and compare sRAGE levels in the alveolar edema fluid and in the plasma from ICU patients enrolled within the first 24 hours after onset of ALI/ARDS and/or severe sepsis/septic shock, and from patients under mechanical ventilation (control group). Edema fluid and plasma samples will be collected simultaneously on day 1, day 3, day 6, and day 28 (or at ICU discharge), in order to describe kinetics of evolution of sRAGE levels. Undiluted pulmonary edema fluid samples will be collected in intubated patients only, and blood samples will be gathered from an indwelling arterial catheter. The concentrations of sRAGE will be measured in duplicate by ELISA.
- Conditions
- Acute Lung Injury, Acute Respiratory Distress Syndrome, Severe Sepsis, Septic Shock, Mechanical Ventilation
- Being tested
- sRAGE
- Keywords
- Receptor for advanced glycation end products (RAGE), Soluble RAGE (sRAGE), Acute Lung Injury (ALI), Acute respiratory distress syndrome (ARDS), Severe sepsis, Septic shock, Alveolar epithelium, Mechanical ventilation, Intensive Care Unit (ICU)
- Medical subject headings
- Acute Lung Injury, Respiratory Distress Syndrome, Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sRAGEOther
The purpose of this observational prospective study is to determine wether sRAGE could be used in an ICU setting as a potential diagnostic and prognostic marker during ALI/ARDS, regardless of associated severe sepsis or septic shock
| Study group | Role | What they receive |
|---|---|---|
| control group | Not described Receives: Other: sRAGE |
What is being measured
The primary outcome is the main question the study is designed to answer.
sRAGE levels in the plasma from ICU patients within the first 24 hours after onset of ALI/ARDS or severe sepsis/septic shock
Measured: within the first 24 hours
Secondary outcomes (1)
To describe kinetics of evolution of sRAGE levels in ICU patients with ALI/ARDS and severe sepsis/septic shock
Measured: in UCU patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2008 (estimated)
- Study startJan 2009
- Primary completionJul 2009
- Study completionJul 2009
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 Acute Lung InjuryStudies 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
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthieu JABAUDON, MD, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00811629
- Sponsor's protocol ID
- CHU-0042
- Status last verified
- Sep 2013
- First submitted
- 18 Dec 2008
- Last updated
- 1 Oct 2013
- Results posted
- No
Publications
Jabaudon M, Blondonnet R, Roszyk L, Bouvier D, Audard J, Clairefond G, Fournier M, Marceau G, Dechelotte P, Pereira B, Sapin V, Constantin JM. Soluble Receptor for Advanced Glycation End-Products Predicts Impaired Alveolar Fluid Clearance in Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2015 Jul 15;192(2):191-9. doi: 10.1164/rccm.201501-0020OC.
PubMed 25932660Jabaudon M, Futier E, Roszyk L, Chalus E, Guerin R, Petit A, Mrozek S, Perbet S, Cayot-Constantin S, Chartier C, Sapin V, Bazin JE, Constantin JM. Soluble form of the receptor for advanced glycation end products is a marker of acute lung injury but not of severe sepsis in critically ill patients. Crit Care Med. 2011 Mar;39(3):480-8. doi: 10.1097/CCM.0b013e318206b3ca.
PubMed 21220996
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soluble Form of the Receptor for Advanced Glycation End Products (sRAGE) Levels in the Pulmonary Edema Fluid and Plasma From ICU Patients With ALI/ARDS and Severe Sepsis : an Observational Prospective Study.
- ClinicalTrials.gov ID
- NCT00811629
- Acronym / sponsor ID
- CHU-0042
- Conditions
- Acute Lung Injury, Acute Respiratory Distress Syndrome, Severe Sepsis, Septic Shock, Mechanical Ventilation
- Keywords
- Receptor for advanced glycation end products (RAGE), Soluble RAGE (sRAGE), Acute Lung Injury (ALI), Acute respiratory distress syndrome (ARDS), Severe sepsis, Septic shock, Alveolar epithelium, Mechanical ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 19 Dec 2008 (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.
sRAGE, the soluble form of the receptor for advanced glycation end products, is a novel marker of alveolar epithelial type I cell injury, but is also involved in acute systemic inflammation. The purpose of this observational prospective study is to determine whether sRAGE could be used in an ICU setting as a potential diagnostic and prognostic marker during ALI/ARDS, regardless of associated severe sepsis or septic shock.
Detailed description
BACKGROUND:
The receptor for advanced glycation end products (RAGE was recently identified as a promising new marker of alveolar type I cell injury. RAGE is a member of the immunoglobulin superfamily that acts as a multiligand receptor and is involved in propagating inflammatory responses. While the precise function of RAGE remains unclear, the elevated levels of RAGE, and its soluble isoform sRAGE, correlate with severity of ALI/ARDS in human and animal studies, and RAGE levels could reflect impaired alveolar fluid clearance. Thus, it is possible that elevated levels of RAGE in ALI/ARDS derive in part from RAGE's role in systemic inflammatory cascades rather than purely from its release from alveolar type I cells.
DESIGN NARRATIVE:
This observational prospective clinical study will describe and compare sRAGE levels in the alveolar edema fluid and in the plasma from ICU patients enrolled within the first 24 hours after onset of ALI/ARDS and/or severe sepsis/septic shock, and from patients under mechanical ventilation (control group). Edema fluid and plasma samples will be collected simultaneously on day 1, day 3, day 6, and day 28 (or at ICU discharge), in order to describe kinetics of evolution of sRAGE levels. Undiluted pulmonary edema fluid samples will be collected in intubated patients only, and blood samples will be gathered from an indwelling arterial catheter. The concentrations of sRAGE will be measured in duplicate by ELISA.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| control group | – | Other: sRAGE |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Definied population
Key inclusion criteria (3 listed)
- ICU patients under mechanical ventilation
- Patients within the first 24 hours after onset of ALI/ARDS according to the 1994 American-European Consensus Conference (AECC)
- Patients within the first 24 hours after onset of severe sepsis or septic shock according to the 1992 ACCP/SCCM Consensus Conference
Key exclusion criteria (6 listed)
- Pregnancy
- Acute exacerbation of diabetes
- Dialysis for end-stage kidney disease
- Alzheimer's disease
- Amyloidosis
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 |
|---|---|---|
| sRAGEThe purpose of this observational prospective study is to determine wether sRAGE could be used in an ICU setting as a potential diagnostic and prognostic marker during ALI/ARDS, regardless of associated severe sepsis or septic shock | Other | control group |
Primary outcome
sRAGE levels in the plasma from ICU patients within the first 24 hours after onset of ALI/ARDS or severe sepsis/septic shock
Time frame: within the first 24 hours
1 secondary outcome
To describe kinetics of evolution of sRAGE levels in ICU patients with ALI/ARDS and severe sepsis/septic shock
Time frame: in UCU patients
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 1 Oct 2013.
- Derived from this study: PubMed 25932660Jabaudon M, Blondonnet R, Roszyk L, Bouvier D, Audard J, Clairefond G, Fournier M, Marceau G, Dechelotte P, Pereira B, Sapin V, Constantin JM. Soluble Receptor for Advanced Glycation End-Products Predicts Impaired Alveolar Fluid Clearance in Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2015 Jul 15;192(2):191-9. doi: 10.1164/rccm.201501-0020OC.
- Derived from this study: PubMed 21220996Jabaudon M, Futier E, Roszyk L, Chalus E, Guerin R, Petit A, Mrozek S, Perbet S, Cayot-Constantin S, Chartier C, Sapin V, Bazin JE, Constantin JM. Soluble form of the receptor for advanced glycation end products is a marker of acute lung injury but not of severe sepsis in critically ill patients. Crit Care Med. 2011 Mar;39(3):480-8. doi: 10.1097/CCM.0b013e318206b3ca.
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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, MD 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 Acute Lung Injury and Acute Respiratory Distress Syndrome, 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 6 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 1 Oct 2013. 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?
sRAGE levels in the plasma from ICU patients within the first 24 hours after onset of ALI/ARDS or severe sepsis/septic shock (time frame: within the first 24 hours). 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 NCT00811629, 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 1 Oct 2013.