Acute Respiratory Distress SyndromePhase 4DAMAGENCT01600651
Diffuse Acute Respiratory Distress Syndrome (ARDS), Recruitment Maneuver, and sRAGE (DAMAGE Study)
A Phase 4 study of Acute Respiratory Distress Syndrome, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
RAGE, the receptor for advanced glycation end products, is a novel marker of alveolar epithelial type I cell injury, and soluble RAGE (sRAGE) is elevated in the plasma and in the pulmonary edema fluid from patients with ALI/ARDS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2012to Oct 2013
- Phase
- Phase 4
- 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
Who may be able to join
- ICU patients under mechanical ventilation
- Patients within the first 24 hours after onset of ARDS according to the 1994 American-European Consensus Conference (AECC)
- PaO2/FiO2 ratio < 200 with external PEEP >5 cmH2O
- "Nonfocal" loss of aeration based on CT scan lung morphology analysis, as defined by the "CT scan ARDS study group" criteria
Who cannot join
- Pregnancy
- Acute exacerbation of diabetes
- Dialysis for end-stage kidney disease
- Alzheimer's disease
- Amyloidosis
- Evolutive neoplastic lesion
Show all 11Show fewer
- Known or suspected history of allergy to cisatracurium
- Chronic respiratory disease requiring long term oxygen therapy or long term ventilation
- Confirmed or suspected elevated intracranial pressure
- Confirmed or suspected bronchopleural fistula, pneumothorax
- Persistent hemodynamic instability despite appropriate resuscitation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects Of A Recruitment Maneuver On Plasma Levels of sRAGE, The Soluble Form of The Receptor For Advanced Glycation End Products, In Patients With Diffuse Acute Respiratory Distress Syndrome (ARDS)
RAGE, the receptor for advanced glycation end products, is a novel marker of alveolar epithelial type I cell injury, and soluble RAGE (sRAGE) is elevated in the plasma and in the pulmonary edema fluid from patients with ALI/ARDS. Few data are available about the influence of ventilatory interventions on levels of sRAGE in the setting of ALI/ARDS. The purpose of this prospective monocentric randomized controlled cross-over study is to describe the effects of a recruitment maneuver (RM) on plasma sRAGE levels during diffuse ARDS.
Read the detailed description
BACKGROUND:
The receptor for advanced glycation end products (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 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 higher sRAGE levels could reflect impaired alveolar fluid clearance. Lung morphology, as assessed by loss of aeration distribution patterns on computed tomography (CT) scan, predicts the response to recruitment maneuvers in patients with ARDS: patients presenting with nonfocal (diffuse) lung morphology are more likely to respond to a RM, resulting in an increase in arterial oxygenation, net alveolar fluid clearance, and significant alveolar recruitment as revealed by pressure-volume curve analysis.
DESIGN NARRATIVE:
The purpose of this prospective, randomized and controlled, cross-over study is to compare the effects of a RM on plasma sRAGE levels (measured 5 minutes before, 5 minutes, 30 minutes, 1 hour, 4 hours and 6 hours after the RM) and plasma sRAGE levels measured during a "sham" or "control" sequence, in patients with diffuse ARDS.
Mechanically ventilated ICU patients with ARDS criteria (based on the 1994 American-European Consensus Conference definition for ARDS) and nonfocal CT scan lung morphology will be included within 24 hours of disease onset. Then, patients will be randomized into 2 groups: a "RM-SHAM" group when RM sequence precedes a sham evaluation period, and a "SHAM-RM" group, in which patients receive a sham sequence before the RM sequence. Patients will receive protective ventilation, as recommended, before, during and after evaluation periods. RM consists of the application of 40 cmH20 airway pressure for 40 seconds.
Blood will be sampled from an indwelling arterial catheter, in order to analyze arterial blood gases and sRAGE levels, 5 minutes before the RM (or a 40 second-long sham period), 5 minutes, 30 minutes, 1 hour, 4 hours and 6 hours after the RM (or a 40 second-long sham period). Electric impedance tomography will be evaluated 5 minutes before and 1 hour after the RM.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- Recruitment Maneuver (RM) sham group, Sham recruitment maneuver (RM) group
- Keywords
- Receptor for advanced glycation end products (RAGE), Soluble RAGE (sRAGE), Recruitment Maneuver, Acute respiratory distress syndrome (ARDS), Alveolar epithelium, Electrical Impedance Tomography, Mechanical ventilation, Intensive Care Unit (ICU)
- 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.
Recruitment Maneuver (RM) sham groupOther
It 's when RM sequence precedes a shame evaluation period
Sham recruitment maneuver (RM) groupOther
Group in which patients receive a sham sequence before the RM sequence
| Study group | Role | What they receive |
|---|---|---|
| Recruitment maneuver (RM) sham group | Sham comparator | when recruitment maneuver sequence precedes a sham evaluation period |
| Sham Recruitment (RM) maneuver group | Sham comparator | a group in which patients receive a sham sequence before the RM sequence Receives: Other: Sham recruitment maneuver (RM) group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma sRAGE
Measured: 1 hour after the RM
Secondary outcomes (5)
Plasma sRAGE in responders and non-responders to RM
Measured: 5 minutes before, then 5 minutes, 30 minutes, 4 hours and 6 hours after RM
Kinetics of sRAGE after RM
Measured: 5 minutes before, and 5 minutes, 30 minutes, 1 hour, 4 hours and 6 hours after RM and after a sham period
Predictive value of baseline sRAGE on the response to RM
Measured: 5 minutes before, and 5 minutes, 30 minutes, 1 hour, 4 hours and 6 hours after RM
Correlation of plasma sRAGE and response to RM with lung aeration
Measured: 5 minutes before, and 5 minutes, 30 minutes, 1 hour, 4 hours and 6 hours after RM or sham period
Risk of RM-related pulmonary bacterial translocation
Measured: 5 minutes before and 30 minutes after RM
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2012 (estimated)
- Study startApr 2012
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01600651
- Sponsor's protocol ID
- CHU-0119
- Acronym
- DAMAGE
- Status last verified
- Aug 2026
- First submitted
- 24 Apr 2012
- Last updated
- 10 Aug 2026
- Results posted
- No
Publications
Jabaudon M, Hamroun N, Roszyk L, Guerin R, Bazin JE, Sapin V, Pereira B, Constantin JM. Effects of a recruitment maneuver on plasma levels of soluble RAGE in patients with diffuse acute respiratory distress syndrome: a prospective randomized crossover study. Intensive Care Med. 2015 May;41(5):846-55. doi: 10.1007/s00134-015-3726-0. Epub 2015 Mar 20.
PubMed 25792206
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of A Recruitment Maneuver On Plasma Levels of sRAGE, The Soluble Form of The Receptor For Advanced Glycation End Products, In Patients With Diffuse Acute Respiratory Distress Syndrome (ARDS)
- ClinicalTrials.gov ID
- NCT01600651
- Acronym / sponsor ID
- DAMAGE / CHU-0119
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- Receptor for advanced glycation end products (RAGE), Soluble RAGE (sRAGE), Recruitment Maneuver, Acute respiratory distress syndrome (ARDS), Alveolar epithelium, Electrical Impedance Tomography, Mechanical ventilation, Intensive Care Unit (ICU)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 17 May 2012 (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.
RAGE, the receptor for advanced glycation end products, is a novel marker of alveolar epithelial type I cell injury, and soluble RAGE (sRAGE) is elevated in the plasma and in the pulmonary edema fluid from patients with ALI/ARDS. Few data are available about the influence of ventilatory interventions on levels of sRAGE in the setting of ALI/ARDS. The purpose of this prospective monocentric randomized controlled cross-over study is to describe the effects of a recruitment maneuver (RM) on plasma sRAGE levels during diffuse ARDS.
Detailed description
BACKGROUND:
The receptor for advanced glycation end products (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 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 higher sRAGE levels could reflect impaired alveolar fluid clearance. Lung morphology, as assessed by loss of aeration distribution patterns on computed tomography (CT) scan, predicts the response to recruitment maneuvers in patients with ARDS: patients presenting with nonfocal (diffuse) lung morphology are more likely to respond to a RM, resulting in an increase in arterial oxygenation, net alveolar fluid clearance, and significant alveolar recruitment as revealed by pressure-volume curve analysis.
DESIGN NARRATIVE:
The purpose of this prospective, randomized and controlled, cross-over study is to compare the effects of a RM on plasma sRAGE levels (measured 5 minutes before, 5 minutes, 30 minutes, 1 hour, 4 hours and 6 hours after the RM) and plasma sRAGE levels measured during a "sham" or "control" sequence, in patients with diffuse ARDS.
Mechanically ventilated ICU patients with ARDS criteria (based on the 1994 American-European Consensus Conference definition for ARDS) and nonfocal CT scan lung morphology will be included within 24 hours of disease onset. Then, patients will be randomized into 2 groups: a "RM-SHAM" group when RM sequence precedes a sham evaluation period, and a "SHAM-RM" group, in which patients receive a sham sequence before the RM sequence. Patients will receive protective ventilation, as recommended, before, during and after evaluation periods. RM consists of the application of 40 cmH20 airway pressure for 40 seconds.
Blood will be sampled from an indwelling arterial catheter, in order to analyze arterial blood gases and sRAGE levels, 5 minutes before the RM (or a 40 second-long sham period), 5 minutes, 30 minutes, 1 hour, 4 hours and 6 hours after the RM (or a 40 second-long sham period). Electric impedance tomography will be evaluated 5 minutes before and 1 hour after the RM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recruitment maneuver (RM) sham group | Sham comparator | –when recruitment maneuver sequence precedes a sham evaluation period |
| Sham Recruitment (RM) maneuver group | Sham comparator | Other: Sham recruitment maneuver (RM) groupa group in which patients receive a sham sequence before the RM sequence |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ICU patients under mechanical ventilation
- Patients within the first 24 hours after onset of ARDS according to the 1994 American-European Consensus Conference (AECC)
- PaO2/FiO2 ratio < 200 with external PEEP >5 cmH2O
- "Nonfocal" loss of aeration based on CT scan lung morphology analysis, as defined by the "CT scan ARDS study group" criteria
Key exclusion criteria (11 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 |
|---|---|---|
| Recruitment Maneuver (RM) sham groupIt 's when RM sequence precedes a shame evaluation period | Other | – |
| Sham recruitment maneuver (RM) groupGroup in which patients receive a sham sequence before the RM sequence | Other | Sham Recruitment (RM) maneuver group |
Primary outcome
Plasma sRAGE
Time frame: 1 hour after the RM
5 secondary outcomes
Plasma sRAGE in responders and non-responders to RM
Time frame: 5 minutes before, then 5 minutes, 30 minutes, 4 hours and 6 hours after RM
Kinetics of sRAGE after RM
Time frame: 5 minutes before, and 5 minutes, 30 minutes, 1 hour, 4 hours and 6 hours after RM and after a sham period
Predictive value of baseline sRAGE on the response to RM
Time frame: 5 minutes before, and 5 minutes, 30 minutes, 1 hour, 4 hours and 6 hours after RM
Correlation of plasma sRAGE and response to RM with lung aeration
Time frame: 5 minutes before, and 5 minutes, 30 minutes, 1 hour, 4 hours and 6 hours after RM or sham period
Risk of RM-related pulmonary bacterial translocation
Time frame: 5 minutes before and 30 minutes after RM
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 10 Aug 2026.
- Results publication: PubMed 25792206Jabaudon M, Hamroun N, Roszyk L, Guerin R, Bazin JE, Sapin V, Pereira B, Constantin JM. Effects of a recruitment maneuver on plasma levels of soluble RAGE in patients with diffuse acute respiratory distress syndrome: a prospective randomized crossover study. Intensive Care Med. 2015 May;41(5):846-55. doi: 10.1007/s00134-015-3726-0. Epub 2015 Mar 20.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of 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 4 inclusion and 11 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 10 Aug 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Plasma sRAGE (time frame: 1 hour after the RM). 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 NCT01600651, which also lists 1 linked publication.
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 10 Aug 2026.