NCT01600651

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

April 24, 2012

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 17, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

October 7, 2013

Status Verified

October 1, 2013

Enrollment Period

1.5 years

First QC Date

April 24, 2012

Last Update Submit

October 1, 2013

Conditions

Acute Respiratory Distress Syndrome

Keywords

Receptor for advanced glycation end products (RAGE)Soluble RAGE (sRAGE)Recruitment ManeuverAcute respiratory distress syndrome (ARDS)Alveolar epitheliumElectrical Impedance TomographyMechanical ventilationIntensive Care Unit (ICU)

Outcome Measures

Primary Outcomes (1)

  • Plasma sRAGE

    1 hour after the RM

Secondary Outcomes (5)

  • Plasma sRAGE in responders and non-responders to RM

    5 minutes before, then 5 minutes, 30 minutes, 4 hours and 6 hours after RM

  • Kinetics of sRAGE after RM

    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

    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

    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

    5 minutes before and 30 minutes after RM

Study Arms (2)

Recruitment maneuver (RM) sham group

SHAM COMPARATOR

when recruitment maneuver sequence precedes a sham evaluation period

Other: Recruitment Maneuver (RM) sham group

Sham Recruitment (RM) maneuver group

SHAM COMPARATOR

a group in which patients receive a sham sequence before the RM sequence

Other: Sham recruitment maneuver (RM) group

Interventions

Recruitment Maneuver (RM) sham groupOTHER

It 's when RM sequence precedes a shame evaluation period

Recruitment maneuver (RM) sham group
Sham recruitment maneuver (RM) groupOTHER

Group in which patients receive a sham sequence before the RM sequence

Sham Recruitment (RM) maneuver group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (1)

  • 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.

    PMID: 25792206DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Intervention Hierarchy (Ancestors)

DemographyPopulation Characteristics

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2012

First Posted

May 17, 2012

Study Start

April 1, 2012

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

October 7, 2013

Record last verified: 2013-10

Locations

FR(1)