AdrenOSS: Adrenomedullin and Outcome in Severe Sepsis and Septic Shock

Sponsor

Sphingotec GmbH (Industry)

Overall Status

Completed

CT.gov ID

NCT02393781

Collaborator

Fondation Transplantation_EDDH (Other), Hopital Lariboisière (Other), Cliniques universitaires Saint-Luc- Université Catholique de Louvain (Other)

596

Enrollment

Locations

Duration (Months)

24.8

Patients Per Site

2.1

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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

Study Design

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 :

Jun 1, 2015

Actual Primary Completion Date :

May 1, 2016

Actual Study Completion Date :

Jun 1, 2016

Outcome Measures

Primary Outcome Measures

rate of all-cause mortality [Day 28.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Cliniques Universitaires Saint-Luc	Brussels	Belgium	1200
2	CH Jolimont	La Louvière	Belgium	7100
3	Clinique St Pierre	Ottignies	Belgium	1340
4	Centre Hospitalier d'Angers	Angers	France	49933
5	Centre Hospitalier d'Angoulême	Angoulême	France	16959
6	Hopital Estaing	Clermont-Ferrand	France	63003
7	Hôpital Louis Mourier,	Colombes	France	92700
8	CHD de la Vendée	La Roche Sur Yon	France	85000
9	CHU Dupuytren	Limoges	France	87042
10	Hôpital St Louis	Paris	France	75010
11	Hôpital Bichat Claude-Bernard	Paris	France	75018
12	Hôpital Lariboisière	Paris	France
13	Nouvel Hôpital Civil	Strasbourg	France	67000
14	Hôpital de Hautepierre	Strasbourg	France	67098
15	CHRU Tours	Tours	France	37044
16	Klinik für Operative Intensivmedizin und Intermediate Care	Aachen	Germany
17	Klinikum Augsburg	Augsburg	Germany	86156
18	Klinik für Anästhesie, Intensivmedizin und Schmerztherapie, HELIOS-Klinikum Erfurt,	Erfurt	Germany	D99089
19	Universitätsklinikum Jena	Jena	Germany	07740
20	Klinik für Anästhesiologie und Operative Intensivmedizin, Universitätsklinikum Köln	Köln	Germany	50937
21	Azienda Ospedaliera Sant'Andrea	Roma	Italy
22	Policlinico Universitario A. Gemelli	Roma	Italy
23	Medisch Spectrum Twente; Departement of Intensive Care	Enschede	Netherlands	7513 ER
24	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

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