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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT00811629
First received: December 18, 2008
Last updated: September 30, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Acute Lung Injury
Acute Respiratory Distress Syndrome
Severe Sepsis
Septic Shock
Mechanical Ventilation
Other: sRAGE

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Soluble Form of the Receptor for Advanced Glycation End Products (sRAGE) Levels in the Pulmonary Edema Fluid and Plasma From ICU Patients With ALI/ARDS and Severe Sepsis : an Observational Prospective Study.

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • sRAGE levels in the plasma from ICU patients within the first 24 hours after onset of ALI/ARDS or severe sepsis/septic shock [ Time Frame: within the first 24 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To describe kinetics of evolution of sRAGE levels in ICU patients with ALI/ARDS and severe sepsis/septic shock [ Time Frame: in UCU patients ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: January 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
control group Other: 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Definied population

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00811629

Locations
France
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Matthieu JABAUDON, MD University Hospital, Clermont-Ferrand
  More Information

No publications provided by University Hospital, Clermont-Ferrand

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT00811629     History of Changes
Other Study ID Numbers: CHU-0042
Study First Received: December 18, 2008
Last Updated: September 30, 2013
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
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)

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Sepsis
Toxemia
Shock
Shock, Septic
Lung Injury
Wounds and Injuries
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Thoracic Injuries

ClinicalTrials.gov processed this record on July 22, 2014