Adrenomedullin and Outcome in Severe Sepsis and Septic Shock

Completed

• Conditions: Severe Sepsis; Septic Shock

• Registration Number: NCT02393781
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2015-03-13
• Study First Submitted QC: 2015-03-13
• Study First Posted: 2015-03-19
• Study Start: 2015-06
• Primary Completion: 2016-05
• Status Verified: 2016-06
• Study Completion: 2016-06
• Last Update Submitted: 2016-06-03
• Last Update Posted: 2016-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 596

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
rate of all-cause mortality	Day 28.

Trial Locations

Locations (24)

Cliniques Universitaires Saint-Luc; 🇧🇪 Brussels, Belgium

CHU Dupuytren; 🇫🇷 Limoges, France

CH Jolimont; 🇧🇪 La Louvière, Belgium

Hopital Estaing; 🇫🇷 Clermont-Ferrand, France

Nouvel Hôpital Civil; 🇫🇷 Strasbourg, France

Clinique St Pierre; 🇧🇪 Ottignies, Belgium

Centre Hospitalier d'Angers; 🇫🇷 Angers, France

Centre Hospitalier d'Angoulême; 🇫🇷 Angoulême, France

Hôpital Louis Mourier,; 🇫🇷 Colombes, France

Klinik für Operative Intensivmedizin und Intermediate Care; 🇩🇪 Aachen, Germany

CHD de la Vendée; 🇫🇷 La Roche Sur Yon, France

Hôpital St Louis; 🇫🇷 Paris, France

Hôpital Bichat Claude-Bernard; 🇫🇷 Paris, France

Hôpital Lariboisière; 🇫🇷 Paris, France

Policlinico Universitario A. Gemelli; 🇮🇹 Roma, Italy

CHRU Tours; 🇫🇷 Tours, France

Klinikum Augsburg; 🇩🇪 Augsburg, Germany

Klinik für Anästhesie, Intensivmedizin und Schmerztherapie, HELIOS-Klinikum Erfurt,; 🇩🇪 Erfurt, Germany

Klinik für Anästhesiologie und Operative Intensivmedizin, Universitätsklinikum Köln; 🇩🇪 Köln, Germany

Medisch Spectrum Twente; Departement of Intensive Care; 🇳🇱 Enschede, Netherlands

Azienda Ospedaliera Sant'Andrea; 🇮🇹 Roma, Italy

UMC Radboudziekenhuis, Dept. Intensive Care; 🇳🇱 Nijmegen, Netherlands

Hôpital de Hautepierre; 🇫🇷 Strasbourg, France

Universitätsklinikum Jena; 🇩🇪 Jena, Germany