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Adrenomedullin and Outcome in Severe Sepsis and Septic Shock (AdrenOSS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02393781
Recruitment Status : Completed
First Posted : March 19, 2015
Last Update Posted : June 6, 2016
Sponsor:
Collaborators:
Fondation Transplantation_EDDH
Hopital Lariboisière
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Information provided by (Responsible Party):
Sphingotec GmbH

Study Description
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Brief Summary:
The aim of this prospective study is to assess the prognostic value of bioactive plasma adrenomedullin (ADM) in 600 patients with severe sepsis or septic shock in an international multicenter study and to validate the findings concerning the association of ADM concentration and the use of vasopressor therapy, organ failure and outcome.

Condition or disease
Severe Sepsis Septic Shock

Detailed Description:

Sepsis involves an overactive inflammatory response to severe bacterial infection that can compromise vascular integrity and cause tissue edema, organ dysfunction and death. Adrenomedullin (ADM) has attracted the interest of researchers because of its powerful physiological functions. An anti-ADM antibody reduced the norepinephrine infusion rates required to achieve hemodynamic targets, increased urine flow and improved creatinine clearance, which ultimately resulted in attenuated systemic inflammation and tissue apoptosis, during resuscitated cecal ligation and puncture (CLP)-induced septic shock in mice.

In humans, plasma ADM has been determined only in a small number of sepsis patients, and - except from one study - the assays used did not selectively measure the bioactive ADM form and have been considered not reliable. Therefore, the potential value of determining plasma ADM in such patients cannot yet be ascertained and the optimal cut off needs to be validated in future studies

Study Design
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Study Type : Observational
Actual Enrollment : 596 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Adrenomedullin and Outcome in Severe Sepsis and Septic Shock. The AdrenOSS Study.
Study Start Date : June 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis Shock

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. rate of all-cause mortality [ Time Frame: Day 28. ]

Biospecimen Retention:   Samples Without DNA
Plasma samples without DNA Blood samples (heparin-, EDTA-, EDTA/aprotinin plasma) and urine samples will be collected at the admission, day 2, day 3 and the day of discharge for measuring ADM and other markers

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
600 patients admitted in intensive care unit of 26 hospitals, in 5 countries, with diagnosis of severe sepsis or septic shock, will be included in this study.
Criteria

Inclusion Criteria:

  • Age >18 years
  • Patients admitted in intensive care unit for severe sepsis or septic shock according to international, standardized criteria,transferred from another intensive care unit less than 24 hours after the primary admission, or being treated with vasopressors for less than 24 hours in the prior ICU
  • Signed Consent form

Exclusion Criteria:

  • Age < 18 years
  • Severe sepsis or septic shock patients transferred from another intensive care unit later than 24 hours after the primary admission or being treated with vasopressors for more than 24 hours in the prior ICU
  • Pregnant women
  • Vegetative coma
  • Participation in an interventional clinical trial in the preceding month
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02393781


Locations
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Sponsors and Collaborators
Sphingotec GmbH
Fondation Transplantation_EDDH
Hopital Lariboisière
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
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Principal Investigator: Alexandre Mebazaa, Pr Hôpital Lariboisière, France
Principal Investigator: Pierre François Laterre, Pr Clinique Universitaire St Luc, Belgique
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sphingotec GmbH
ClinicalTrials.gov Identifier: NCT02393781    
Other Study ID Numbers: 2014-A01906-41
First Posted: March 19, 2015    Key Record Dates
Last Update Posted: June 6, 2016
Last Verified: June 2016
Keywords provided by Sphingotec GmbH:
severe sepsis
septic shock
adrenomedullin
organ dysfunction
Additional relevant MeSH terms:
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Sepsis
Toxemia
Shock, Septic
Shock
 Infections
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes