Hydrocortisone for Prevention of Septic Shock
- Registration Number
- NCT00670254
- Lead Sponsor
- Charite University, Berlin, Germany
- 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 recommended only in patients after severe septic shock has been established. Hydrocortisone therapy has a hemodynamic stabilizing effect and may reverse shock, however, the preventive application has not been investigated in a larger study. The study investigates whether low dose hydrocortisone prevents the development of shock in patients with severe sepsis. It is postulated that shock prevention may also affect morbidity and mortality.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 380
- Severe sepsis according to ACCP/CCM criteria
- Onset of severe sepsis < 48 hours
- Informed consent
- Effective contraception in fertile women
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hydrocortisone Hydrocortisone - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Septic shock 14 days
- Secondary Outcome Measures
Name Time Method Time to death 28, 90, and 180 days Immune response to hydrocortisone 6 days Adrenal function baseline Mortality 28, 90, and 180 days; ICU and hospital Length of stay ICU and hospital (3-6 months) Time to septic shock 14 days Mechanical ventilation until ICU discharge Renal replacement therapy until ICU discharge Organ dysfunction (SOFA score) until ICU discharge but day 14 at maximum Frequency of weaning failure until ICU discharge Frequency and severity of muscle weakness until ICU discharge Frequency of gastrointestinal bleeding 28 days Frequency of secondary infections 28 days Delir ICU discharge Hypernatremia 14 days Hyperglycemia 14 days Other adverse events 28 days Posttraumatic stress disorder / health-related quality of life Hosptal discharge and 180 days after hospital discharge
Trial Locations
- Locations (30)
Universitaetsklinikum Aachen, Operative Intensivmedizin Erwachsene
🇩🇪Aachen, Germany
Zentralklinik Bad Berka GmbH, Zentrum für Anaesthesie, Intensivtherapie und Notfallmedizin
🇩🇪Bad Berka, Germany
HELIOS Klinikum Bad Saarow; Zentrum für Anaesthesiologie, Intensivmedizin, Notfallmedizin und Schmerztherapie
🇩🇪Bad Saarow, Germany
St. Joseph Krankenhaus, Institut fue Anaesthesie, Schwerpunkt operative Intensivmedizin und SchmerztherapieAnaesthesie, operative Intensiv- und Notfallmedizin
🇩🇪Berlin, Germany
Vivantes Auguste-Viktoria-Klinikum, Klinik fuer Anaesthesiologie, Intensivmedizin und Schmerztherapie
🇩🇪Berlin, Germany
Vivantes Klinikum Neukoelln,Klinik fuer Innere Medizin, Kardiologie und konservative Intensivmedizin
🇩🇪Berlin, Germany
Vivantes Klinikum-Neukoelln, Klinik fuer Anaesthesie, operative Intensivmedizin und Schmerztherapie
🇩🇪Berlin, Germany
Vivantes Klinikum Hellersdorf, Klinik fuer Anaesthesie, operative Intensivmedizin und Schmerztherapie
🇩🇪Berlin, Germany
Helios Klinikum Berlin Buch, Klinik für Intensivmedizin
🇩🇪Berlin, Germany
Charité Universitaetsmedizin Berlin, Campus Virchow-Klinikum und Campus Mitte, Med. Klinik mit Schwerpunkt Infektiologie und Pneumologie
🇩🇪Berlin, Germany
Scroll for more (20 remaining)Universitaetsklinikum Aachen, Operative Intensivmedizin Erwachsene🇩🇪Aachen, Germany