Predictive Values of Plasma Soluble RAGE Levels and RAGE Polymorphisms for the Onset of Acute Respiratory Distress Syndrome in Critically Ill Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- development of ARDS
Study Overview
Brief Summary
Current clinical prediction scores for acute respiratory distress syndrome (ARDS) have limited positive predictive value. No studies have evaluated predictive kinetics of plasma biomarkers and receptor for advanced glycation end products (RAGE) polymorphisms in a broad population of critically ill patients or as an adjunct to clinical prediction scores.
The main objective of the investigators study is to evaluate the predictive values of plasma soluble RAGE levels for the onset of ARDS in a high risk population of patients admitted to the intensive care unit (ICU).
One of the investigators goals is to improve early identification of patients at risk for ARDS in order to better implement preventive stategies prior to ARDS development.
The primary outcome is the occurrence of ARDS during the first week after admission to the ICU.
Detailed Description
BACKGROUND :
ARDS is a major cause of morbidity and mortality in critically ill patients. Only few pharmacological treatments are available, with limited evidence of efficacy.
The development of efficient preventive stategies is limited by the investigators inability to predict which patients are likely to develop ARDS. The Lung Injury predicition Score (LIPS) has been developed to identify patients at high risk for ARDS, but its predictive value remains limited.
The receptor for advanced glycation end product (RAGE) is now identified as a marker of alveolar type I cell injury. RAGE is a member of the immunoglobulin superfamily that acts as a multiligand receptor which is involved in propagating inflammatory responses. Plasma levels of sRAGE are correlated with clinical and radiologic severity in ARDS patients.
The investigators main objective is to assess the predictive values of plasma sRAGE and esRAGE levels, as well as their evolution over the first 24 hours after admission, for the onset of ARDS in high risk patients.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients admitted to the ICU
- •Patients presenting with risk factors for ARDS : high risk surgery, sepsis, shock, panceatitis, pneumonia, aspiration, drowning, massive transfusion, pulmonary contusion, serious burn, severe trauma.
- •Informed consent
Exclusion Criteria
- •Pregnancy
- •Age < 18 years
- •Criteria for ARDS at admission to the ICU
- •Expected survival under 48 hours
Outcomes
Primary Outcomes
development of ARDS
Time Frame: during the first week after admission to the ICU
The development of ARDS, based on Berlin definition criteria, during the first week after admission to the ICU
Secondary Outcomes
- Plasma sRAGE and esRAGE levels((Day 1))
- Maximal plasma levels of sRAGE and esRAGE(during the first 24 hours after ICU admission)
- Evolution of plasma sRAGE levels(between day 0 and day 1)
- Development of ARDS(during at day 14 and day 30 after ICU admission)
- Total duration of mechanical ventilation(at day 1)
- Length of stay in ICU(at day 1)