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

Septic Shock Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00811629
• Other study ID #: CHU-0042
• Status: Completed
• Phase: N/A
• First received: December 18, 2008
• Last updated: September 30, 2013
• Start date: January 2009
• Est. completion date: July 2009

Study information

• Verified date: September 2013
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Lung Injury
• Mechanical Ventilation
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Sepsis
• Septic Shock
• Severe Sepsis
• Shock, Septic
• Toxemia

Intervention

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

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	To describe kinetics of evolution of sRAGE levels in ICU patients with ALI/ARDS and severe sepsis/septic shock		in UCU patients	Yes