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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
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome Other: Recruitment Maneuver (RM) sham group Other: Sham recruitment maneuver (RM) group Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Plasma sRAGE [ Time Frame: 1 hour after the RM ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. Risk of RM-related pulmonary bacterial translocation [ Time Frame: 5 minutes before and 30 minutes after RM ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Pregnancy
  • Acute exacerbation of diabetes
  • Dialysis for end-stage kidney disease
  • Alzheimer's disease
  • Amyloidosis
  • Evolutive neoplastic lesion
  • 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

Information from the National Library of Medicine

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


Locations
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France
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01600651     History of Changes
Other Study ID Numbers: CHU-0119
First Posted: May 17, 2012    Key Record Dates
Last Update Posted: October 7, 2013
Last Verified: October 2013
Keywords provided by University Hospital, Clermont-Ferrand:
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)
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury