Influence of Acute Respiratory Distress Syndrome (ARDS) and Severe Sepsis on sRAGE Levels in ICU Patients

NCT ID: NCT00811629

Last Updated: 2013-10-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2009-07-31

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.

Detailed Description

BACKGROUND:

The receptor for advanced glycation end products (RAGE was recently identified as a promising new 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 RAGE levels could reflect impaired alveolar fluid clearance. Thus, it is possible that elevated levels of RAGE in ALI/ARDS derive in part from RAGE's role in systemic inflammatory cascades rather than purely from its release from alveolar type I cells.

DESIGN NARRATIVE:

This observational prospective clinical study will describe and compare sRAGE levels in the alveolar edema fluid and in the plasma from ICU patients enrolled within the first 24 hours after onset of ALI/ARDS and/or severe sepsis/septic shock, and from patients under mechanical ventilation (control group). Edema fluid and plasma samples will be collected simultaneously on day 1, day 3, day 6, and day 28 (or at ICU discharge), in order to describe kinetics of evolution of sRAGE levels. Undiluted pulmonary edema fluid samples will be collected in intubated patients only, and blood samples will be gathered from an indwelling arterial catheter. The concentrations of sRAGE will be measured in duplicate by ELISA.

Conditions

Acute Lung Injury; Acute Respiratory Distress Syndrome; Severe Sepsis; Septic Shock; Mechanical Ventilation

Keywords

Receptor for advanced glycation end products (RAGE); Soluble RAGE (sRAGE); Acute Lung Injury (ALI); Acute respiratory distress syndrome (ARDS); Severe sepsis; Septic shock; Alveolar epithelium; Mechanical ventilation; Intensive Care Unit (ICU)

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

control group

sRAGE

Intervention Type: OTHER

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

Interventions

sRAGE

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthieu JABAUDON, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

CHU Clermont-Ferrand

Clermont-Ferrand, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 25932660 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 21220996 (View on PubMed)

Other Identifiers

CHU-0042

Identifier Type: -

Identifier Source: org_study_id