Adrenomedullin and Outcome in Severe Sepsis and Septic Shock

Septic Shock Clinical Trial

— AdrenOSS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02393781
• Other study ID #: 2014-A01906-41
• Status: Completed
• Phase: N/A
• First received: March 13, 2015
• Last updated: June 3, 2016
• Start date: June 2015
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: Sphingotec GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Comité pour la Protection des Personnes, CPP EST IIIBelgium : Comité d'éthique, Université Catholique de Louvain, Clinique Universitaire St LucGermany : Ethik-Kommission an der Medizinischen Fakultät der Rheinisch-Westfälischen Technischen Hochschule Aachen (RWTH Aachen)Italy : Comitato Etico dell'Università, RomaNed : CMO Regio Arnhem TNijmegen
• Study type: Observational

Clinical 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 failure and outcome.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 596
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Sepsis
• Septic Shock
• Severe Sepsis
• Shock
• Shock, Septic
• Toxemia

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint-Luc	Brussels
Belgium	CH Jolimont	La Louvière
Belgium	Clinique St Pierre	Ottignies
France	Centre Hospitalier d'Angers	Angers
France	Centre Hospitalier d'Angoulême	Angoulême
France	Hopital Estaing	Clermont-Ferrand
France	Hôpital Louis Mourier,	Colombes
France	CHD de la Vendée	La Roche Sur Yon
France	CHU Dupuytren	Limoges
France	Hôpital Bichat Claude-Bernard	Paris
France	Hôpital Lariboisière	Paris
France	Hôpital St Louis	Paris
France	Hôpital de Hautepierre	Strasbourg
France	Nouvel Hôpital Civil	Strasbourg
France	CHRU Tours	Tours
Germany	Klinik für Operative Intensivmedizin und Intermediate Care	Aachen
Germany	Klinikum Augsburg	Augsburg
Germany	Klinik für Anästhesie, Intensivmedizin und Schmerztherapie, HELIOS-Klinikum Erfurt,	Erfurt
Germany	Universitätsklinikum Jena	Jena
Germany	Klinik für Anästhesiologie und Operative Intensivmedizin, Universitätsklinikum Köln	Köln
Italy	Azienda Ospedaliera Sant'Andrea	Roma
Italy	Policlinico Universitario A. Gemelli	Roma
Netherlands	Medisch Spectrum Twente; Departement of Intensive Care	Enschede
Netherlands	UMC Radboudziekenhuis, Dept. Intensive Care	Nijmegen

Sponsors (4)

Lead Sponsor	Collaborator
Sphingotec GmbH	Cliniques universitaires Saint-Luc- Université Catholique de Louvain, Fondation Transplantation_EDDH, Hopital Lariboisière

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Italy,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of all-cause mortality		Day 28.	No