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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

Tracking Information
First Submitted Date March 13, 2015
First Posted Date March 19, 2015
Last Update Posted Date June 6, 2016
Study Start Date June 2015
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 13, 2015)
rate of all-cause mortality [ Time Frame: Day 28. ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Adrenomedullin and Outcome in Severe Sepsis and Septic Shock
Official Title Adrenomedullin and Outcome in Severe Sepsis and Septic Shock. The AdrenOSS Study.
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.
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
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
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.
Condition
  • Severe Sepsis
  • Septic Shock
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 3, 2016)
596
Original Estimated Enrollment
 (submitted: March 13, 2015)
600
Actual Study Completion Date June 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium,   France,   Germany,   Italy,   Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT02393781
Other Study ID Numbers 2014-A01906-41
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Sphingotec GmbH
Study Sponsor Sphingotec GmbH
Collaborators
  • Fondation Transplantation_EDDH
  • Hopital Lariboisière
  • Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
Principal Investigator: Alexandre Mebazaa, Pr Hôpital Lariboisière, France
Principal Investigator: Pierre François Laterre, Pr Clinique Universitaire St Luc, Belgique
PRS Account Sphingotec GmbH
Verification Date June 2016