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Severe SepsisAdrenOSSNCT02393781

Adrenomedullin and Outcome in Severe Sepsis and Septic Shock

An observational study of Severe Sepsis and Septic Shock, run by Sphingotec GmbH at 24 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Severe Sepsis, Septic Shock
How many people
596 participants
Where
24 sitesin 5 countries
Study dates
Jun 2015to Jun 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

24 sites in 5 countries.

24 sites in 5 countries

France12 sites

  • Centre Hospitalier d'Angers

    Angers, 49933

  • Centre Hospitalier d'Angoulême

    Angoulême, 16959

  • Hopital Estaing

    Clermont-Ferrand, 63003

  • Hôpital Louis Mourier,

    Colombes, 92700

  • CHD de la Vendée

    La Roche-sur-Yon, 85000

  • CHU Dupuytren

    Limoges, 87042

  • Hôpital St Louis

    Paris, 75010

  • Hôpital Bichat Claude-Bernard

    Paris, 75018

  • Hôpital Lariboisière

    Paris

  • Nouvel Hôpital Civil

    Strasbourg, 67000

  • Hôpital de Hautepierre

    Strasbourg, 67098

  • CHRU Tours

    Tours, 37044

Other trials in France

Germany5 sites

  • Klinik für Operative Intensivmedizin und Intermediate Care

    Aachen

  • Klinikum Augsburg

    Augsburg, 86156

  • Klinik für Anästhesiologie und Operative Intensivmedizin, Universitätsklinikum Köln

    Cologne, 50937

  • Klinik für Anästhesie, Intensivmedizin und Schmerztherapie, HELIOS-Klinikum Erfurt,

    Erfurt, D99089

  • Universitätsklinikum Jena

    Jena, 07740

Other trials in Germany

Belgium3 sites

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • CH Jolimont

    La Louvière, 7100

  • Clinique St Pierre

    Ottignies, 1340

Other trials in Belgium

Italy2 sites

  • Azienda Ospedaliera Sant'Andrea

    Roma

  • Policlinico Universitario A. Gemelli

    Roma

Other trials in Italy

Netherlands2 sites

  • Medisch Spectrum Twente; Departement of Intensive Care

    Enschede, Enschede, 7513 ER

  • UMC Radboudziekenhuis, Dept. Intensive Care

    Nijmegen, 6525

Other trials in Netherlands

About this study

Official title: 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.

Read the 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

Keywords
severe sepsis, septic shock, adrenomedullin, organ dysfunction
Medical subject headings
Sepsis, Shock, Septic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. rate of all-cause mortality

    Measured: Day 28.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2015 (estimated)
  2. Study startJun 2015
  3. Primary completionMay 2016
  4. Study completionJun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
596 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02393781
Sponsor's protocol ID
2014-A01906-41
Acronym
AdrenOSS
Status last verified
Jun 2016
First submitted
13 Mar 2015
Last updated
6 Jun 2016
Results posted
No
Data monitoring committee
No

Publications

  • Jolly L, Carrasco K, Salcedo-Magguilli M, Garaud JJ, Lambden S, van der Poll T, Mebazaa A, Laterre PF, Gibot S, Boufenzer A, Derive M. sTREM-1 is a specific biomarker of TREM-1 pathway activation. Cell Mol Immunol. 2021 Aug;18(8):2054-2056. doi: 10.1038/s41423-021-00733-5. Epub 2021 Jul 19. No abstract available.

    PubMed 34282296

  • Blet A, Deniau B, Santos K, van Lier DPT, Azibani F, Wittebole X, Chousterman BG, Gayat E, Hartmann O, Struck J, Bergmann A, Antonelli M, Beishuizen A, Constantin JM, Damoisel C, Deye N, Di Somma S, Dugernier T, Francois B, Gaudry S, Huberlant V, Lascarrou JB, Marx G, Mercier E, Oueslati H, Pickkers P, Sonneville R, Legrand M, Laterre PF, Mebazaa A; AdrenOSS-1 Study Investigators. Monitoring circulating dipeptidyl peptidase 3 (DPP3) predicts improvement of organ failure and survival in sepsis: a prospective observational multinational study. Crit Care. 2021 Feb 15;25(1):61. doi: 10.1186/s13054-021-03471-2.

    PubMed 33588925

  • Mebazaa A, Geven C, Hollinger A, Wittebole X, Chousterman BG, Blet A, Gayat E, Hartmann O, Scigalla P, Struck J, Bergmann A, Antonelli M, Beishuizen A, Constantin JM, Damoisel C, Deye N, Di Somma S, Dugernier T, Francois B, Gaudry S, Huberlant V, Lascarrou JB, Marx G, Mercier E, Oueslati H, Pickkers P, Sonneville R, Legrand M, Laterre PF; AdrenOSS-1 study investigators. Circulating adrenomedullin estimates survival and reversibility of organ failure in sepsis: the prospective observational multinational Adrenomedullin and Outcome in Sepsis and Septic Shock-1 (AdrenOSS-1) study. Crit Care. 2018 Dec 21;22(1):354. doi: 10.1186/s13054-018-2243-2.

    PubMed 30583748

  • Hollinger A, Wittebole X, Francois B, Pickkers P, Antonelli M, Gayat E, Chousterman BG, Lascarrou JB, Dugernier T, Di Somma S, Struck J, Bergmann A, Beishuizen A, Constantin JM, Damoisel C, Deye N, Gaudry S, Huberlant V, Marx G, Mercier E, Oueslati H, Hartmann O, Sonneville R, Laterre PF, Mebazaa A, Legrand M. Proenkephalin A 119-159 (Penkid) Is an Early Biomarker of Septic Acute Kidney Injury: The Kidney in Sepsis and Septic Shock (Kid-SSS) Study. Kidney Int Rep. 2018 Aug 22;3(6):1424-1433. doi: 10.1016/j.ekir.2018.08.006. eCollection 2018 Nov.

    PubMed 30450469

Questions about this trial

What is this clinical trial studying?

An observational study of Severe Sepsis and Septic Shock, run by Sphingotec GmbH at 24 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in France, Germany, Belgium, Italy, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

rate of all-cause mortality (time frame: Day 28.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02393781, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2016.

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