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

June 3, 2016 updated by: Sphingotec GmbH

Adrenomedullin and Outcome in Severe Sepsis and Septic Shock. The AdrenOSS Study.

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

596

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint-Luc
      • La Louvière, Belgium, 7100
        • CH Jolimont
      • Ottignies, Belgium, 1340
        • Clinique St Pierre
  • France
      • Angers, France, 49933
        • Centre Hospitalier D'Angers
      • Angoulême, France, 16959
        • Centre Hospitalier d'Angoulème
      • Clermont-Ferrand, France, 63003
        • Hopital Estaing
      • Colombes, France, 92700
        • Hôpital Louis Mourier,
      • La Roche Sur Yon, France, 85000
        • CHD de la Vendée
      • Limoges, France, 87042
        • Chu Dupuytren
      • Paris, France
        • Hôpital Lariboisière
      • Paris, France, 75018
        • Hopital Bichat Claude-Bernard
      • Paris, France, 75010
        • Hopital St Louis
      • Strasbourg, France, 67098
        • Hopital de Hautepierre
      • Strasbourg, France, 67000
        • Nouvel Hopital Civil
      • Tours, France, 37044
        • CHRU Tours
  • Germany
      • Aachen, Germany
        • Klinik für Operative Intensivmedizin und Intermediate Care
      • Augsburg, Germany, 86156
        • Klinikum Augsburg
      • Erfurt, Germany, D99089
        • Klinik für Anästhesie, Intensivmedizin und Schmerztherapie, HELIOS-Klinikum Erfurt,
      • Jena, Germany, 07740
        • Universitätsklinikum Jena
      • Köln, Germany, 50937
        • Klinik für Anästhesiologie und Operative Intensivmedizin, Universitätsklinikum Köln
  • Italy
      • Roma, Italy
        • Policlinico Universitario A. Gemelli
      • Roma, Italy
        • Azienda Ospedaliera Sant'Andrea
  • Netherlands
      • Enschede, Netherlands, 7513 ER
        • Medisch Spectrum Twente; Departement of Intensive Care
      • Nijmegen, Netherlands, 6525
        • UMC Radboudziekenhuis, Dept. Intensive Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
rate of all-cause mortality
Time Frame: Day 28.
Day 28.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sphingotec GmbH

Collaborators

Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Hopital Lariboisière
Fondation Transplantation_EDDH

Investigators

  • Principal Investigator: Alexandre Mebazaa, Pr, Hôpital Lariboisière, France
  • Principal Investigator: Pierre François Laterre, Pr, Clinique Universitaire St Luc, Belgique

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

March 13, 2015

First Submitted That Met QC Criteria

March 13, 2015

First Posted (Estimate)

March 19, 2015

Study Record Updates

Last Update Posted (Estimate)

June 6, 2016

Last Update Submitted That Met QC Criteria

June 3, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-A01906-41

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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