Status:
COMPLETED
Hydrocortisone for Prevention of Septic Shock
Lead Sponsor:
Charite University, Berlin, Germany
Collaborating Sponsors:
German Federal Ministry of Education and Research
SepNet - Critical Care Trials Group
Conditions:
Severe Sepsis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Severe sepsis is a disease with a high mortality. Development of shock is a most serious complication and increases the risk of death considerably. Application of low dose hydrocortisone is currently ...
Eligibility Criteria
Inclusion
- Severe sepsis according to ACCP/CCM criteria
- Onset of severe sepsis \< 48 hours
- Informed consent
- Effective contraception in fertile women
Exclusion
- Septic shock
- Known hypersensitivity to hydrocortisone and additives
- Glucocorticoid history which warrants continuation of glucocorticoid administration
- Other indication for systemic glucocorticoid therapy
- DNR-order
- Moribund patient
- Pregnancy
- Breast feeding women
- Age \< 18 years
- Other interventional study
- Relationship to investigator
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
380 Patients enrolled
Trial Details
Trial ID
NCT00670254
Start Date
January 1 2009
End Date
August 1 2013
Last Update
September 27 2013
Active Locations (30)
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1
Universitaetsklinikum Aachen, Operative Intensivmedizin Erwachsene
Aachen, Germany, 52074
2
Zentralklinik Bad Berka GmbH, Zentrum für Anaesthesie, Intensivtherapie und Notfallmedizin
Bad Berka, Germany, 99437
3
HELIOS Klinikum Bad Saarow; Zentrum für Anaesthesiologie, Intensivmedizin, Notfallmedizin und Schmerztherapie
Bad Saarow, Germany, 15526
4
St. Joseph Krankenhaus, Institut fue Anaesthesie, Schwerpunkt operative Intensivmedizin und SchmerztherapieAnaesthesie, operative Intensiv- und Notfallmedizin
Berlin, Germany, 12101