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

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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

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


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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




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


Information from the National Library of Medicine

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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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sphingotec GmbH
ClinicalTrials.gov Identifier: NCT02393781     History of Changes
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
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Adrenomedullin
Antihypertensive Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Cardiotonic Agents
Vasodilator Agents
Protective Agents