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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 13 June 2016
Main ID:  NCT02393781
Date of registration: 13/03/2015
Prospective Registration: Yes
Primary sponsor: Sphingotec GmbH
Public title: Adrenomedullin and Outcome in Severe Sepsis and Septic Shock AdrenOSS
Scientific title: Adrenomedullin and Outcome in Severe Sepsis and Septic Shock. The AdrenOSS Study.
Date of first enrolment: June 2015
Target sample size: 596
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02393781
Study type:  Observational
Study design:  Observational Model: Case-Only, Time Perspective: Prospective  
Phase:  N/A
Countries of recruitment
Belgium France Germany Italy Netherlands
Contacts
Name:     Pierre François Laterre, Pr
Address: 
Telephone:
Email:
Affiliation:  Clinique Universitaire St Luc, Belgique
Name:     Alexandre Mebazaa, Pr
Address: 
Telephone:
Email:
Affiliation:  Hôpital Lariboisière, France
Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Septic Shock
Severe Sepsis
Intervention(s)
Primary Outcome(s)
rate of all-cause mortality [Time Frame: Day 28.]
Secondary Outcome(s)
Secondary ID(s)
2014-A01906-41
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Fondation Transplantation_EDDH
Hopital Lariboisière
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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