NCT02393781

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
596

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2015

Shorter than P25 for all trials

Geographic Reach
5 countries

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 19, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

June 6, 2016

Status Verified

June 1, 2016

Enrollment Period

11 months

First QC Date

March 13, 2015

Last Update Submit

June 3, 2016

Conditions

Severe SepsisSeptic Shock

Keywords

severe sepsisseptic shockadrenomedullinorgan dysfunction

Outcome Measures

Primary Outcomes (1)

  • rate of all-cause mortality

    Day 28.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

CH Jolimont

La Louvière, 7100, Belgium

Location

Clinique St Pierre

Ottignies, 1340, Belgium

Location

Centre Hospitalier d'Angers

Angers, 49933, France

Location

Centre Hospitalier d'Angoulême

Angoulême, 16959, France

Location

Hopital Estaing

Clermont-Ferrand, 63003, France

Location

Hôpital Louis Mourier,

Colombes, 92700, France

Location

CHD de la Vendée

La Roche-sur-Yon, 85000, France

Location

CHU Dupuytren

Limoges, 87042, France

Location

Hôpital St Louis

Paris, 75010, France

Location

Hôpital Bichat Claude-Bernard

Paris, 75018, France

Location

Hôpital Lariboisière

Paris, France

Location

Nouvel Hôpital Civil

Strasbourg, 67000, France

Location

Hôpital de Hautepierre

Strasbourg, 67098, France

Location

CHRU Tours

Tours, 37044, France

Location

Klinik für Operative Intensivmedizin und Intermediate Care

Aachen, Germany

Location

Klinikum Augsburg

Augsburg, 86156, Germany

Location

Klinik für Anästhesiologie und Operative Intensivmedizin, Universitätsklinikum Köln

Cologne, 50937, Germany

Location

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

Erfurt, D99089, Germany

Location

Universitätsklinikum Jena

Jena, 07740, Germany

Location

Azienda Ospedaliera Sant'Andrea

Roma, Italy

Location

Policlinico Universitario A. Gemelli

Roma, Italy

Location

Medisch Spectrum Twente; Departement of Intensive Care

Enschede, Enschede, 7513 ER, Netherlands

Location

UMC Radboudziekenhuis, Dept. Intensive Care

Nijmegen, 6525, Netherlands

Location

Related Publications (4)

  • 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.

    PMID: 34282296DERIVED

  • 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.

    PMID: 33588925DERIVED

  • 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.

    PMID: 30583748DERIVED

  • 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.

    PMID: 30450469DERIVED

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

MeSH Terms

Conditions

SepsisShock, Septic

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Alexandre Mebazaa, Pr

    Hôpital Lariboisière, France

    PRINCIPAL INVESTIGATOR

  • Pierre François Laterre, Pr

    Clinique Universitaire St Luc, Belgique

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2015

First Posted

March 19, 2015

Study Start

June 1, 2015

Primary Completion

May 1, 2016

Study Completion

June 1, 2016

Last Updated

June 6, 2016

Record last verified: 2016-06

Locations

NL(2)BE(3)IT(2)FR(12)DE(5)