Predictive Values of Plasma Soluble RAGE Levels and RAGE Polymorphisms for the Onset of Acute Respiratory Distress Syndrome in Critically Ill Patients

NCT02070536 | Completed

• 1 other identifier: CHU-0182
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Intensive Care Unit; Population at High Risk for ARDS Development

Keywords

Acute Respiratory Distress Syndrome (ARDS); Receptor for advanced glycation end products (RAGE); Soluble RAGE (sRAGE); Gene polymorphisms; Biomarker

Outcome Measures

Primary Outcomes (1)

• development of ARDS

  The development of ARDS, based on Berlin definition criteria, during the first week after admission to the ICU

  during the first week after admission to the ICU

Secondary Outcomes (7)

• Plasma sRAGE and esRAGE levels

  at ICU admission (Day 0)

• Plasma sRAGE and esRAGE levels

  (Day 1)

• Evolution of plasma sRAGE levels

  between day 0 and day 1

• Maximal plasma levels of sRAGE and esRAGE

  during the first 24 hours after ICU admission

• Development of ARDS

  during at day 14 and day 30 after ICU admission

Study Arms (1)

ARDS (Acute Respiratory Distress Syndrome)

Other: sRAGE

Interventions

sRAGE OTHER

ARDS (Acute Respiratory Distress Syndrome)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Population at high risk for ARDS development

You may qualify if:

• 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

You may not qualify if:

• Pregnancy
• Age \< 18 years
• Criteria for ARDS at admission to the ICU
• Expected survival under 48 hours

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (2)

• Blondonnet R, Joubert E, Godet T, Berthelin P, Pranal T, Roszyk L, Chabanne R, Eisenmann N, Lautrette A, Belville C, Cayot S, Gillart T, Souweine B, Bouvier D, Blanchon L, Sapin V, Pereira B, Constantin JM, Jabaudon M. Driving pressure and acute respiratory distress syndrome in critically ill patients. Respirology. 2019 Feb;24(2):137-145. doi: 10.1111/resp.13394. Epub 2018 Sep 5.

  PMID: 30183115 DERIVED

• Pranal T, Pereira B, Berthelin P, Roszyk L, Godet T, Chabanne R, Eisenmann N, Lautrette A, Belville C, Blondonnet R, Cayot S, Gillart T, Skrzypczak Y, Souweine B, Bouvier D, Blanchon L, Sapin V, Constantin JM, Jabaudon M. Clinical and Biological Predictors of Plasma Levels of Soluble RAGE in Critically Ill Patients: Secondary Analysis of a Prospective Multicenter Observational Study. Dis Markers. 2018 May 10;2018:7849675. doi: 10.1155/2018/7849675. eCollection 2018.

  PMID: 29861796 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Matthieu JABAUDON

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2014
• First Posted: February 25, 2014
• Study Start: February 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 12, 2020

Record last verified: 2014-02

Locations

FR (1)