Diffuse Acute Respiratory Distress Syndrome (ARDS), Recruitment Maneuver, and sRAGE (DAMAGE Study) (DAMAGE)
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|ClinicalTrials.gov Identifier: NCT01600651|
Recruitment Status : Completed
First Posted : May 17, 2012
Last Update Posted : October 7, 2013
|Condition or disease||Intervention/treatment||Phase|
|Acute Respiratory Distress Syndrome||Other: Recruitment Maneuver (RM) sham group Other: Sham recruitment maneuver (RM) group||Phase 4|
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.
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Crossover Assignment|
|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)|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||October 2013|
Sham Comparator: Recruitment maneuver (RM) sham group
when recruitment maneuver sequence precedes a sham evaluation period
Other: Recruitment Maneuver (RM) sham group
It 's when RM sequence precedes a shame evaluation period
Sham Comparator: Sham Recruitment (RM) maneuver group
a group in which patients receive a sham sequence before the RM sequence
Other: Sham recruitment maneuver (RM) group
Group in which patients receive a sham sequence before the RM sequence
- Plasma sRAGE [ Time Frame: 1 hour after the RM ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01600651
|Clermont-Ferrand, France, 63003|