NCT00811629

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2009

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

December 18, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 19, 2008

Completed
13 days until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

October 1, 2013

Status Verified

September 1, 2013

Enrollment Period

6 months

First QC Date

December 18, 2008

Last Update Submit

September 30, 2013

Conditions

Acute Lung InjuryAcute Respiratory Distress SyndromeSevere SepsisSeptic ShockMechanical Ventilation

Keywords

Receptor for advanced glycation end products (RAGE)Soluble RAGE (sRAGE)Acute Lung Injury (ALI)Acute respiratory distress syndrome (ARDS)Severe sepsisSeptic shockAlveolar epitheliumMechanical ventilationIntensive Care Unit (ICU)

Outcome Measures

Primary Outcomes (1)

  • sRAGE levels in the plasma from ICU patients within the first 24 hours after onset of ALI/ARDS or severe sepsis/septic shock

    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

    in UCU patients

Study Arms (1)

control group

Other: sRAGE

Interventions

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

control group

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Definied population

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (2)

  • 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.

    PMID: 25932660DERIVED

  • Jabaudon 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.

    PMID: 21220996DERIVED

MeSH Terms

Conditions

Acute Lung InjuryRespiratory Distress SyndromeSepsisShock, Septic

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract DiseasesRespiration DisordersInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Matthieu JABAUDON, MD

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2008

First Posted

December 19, 2008

Study Start

January 1, 2009

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

October 1, 2013

Record last verified: 2013-09

Locations

FR(1)