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Hydrocortisone for Prevention of Septic Shock (HYPRESS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00670254
Recruitment Status : Completed
First Posted : May 1, 2008
Last Update Posted : September 27, 2013
Sponsor:
Collaborators:
German Federal Ministry of Education and Research
SepNet - Critical Care Trials Group
Coordination Centre for Clinical Trials Leipzig
Information provided by (Responsible Party):
Didier Keh, 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.

Condition or disease Intervention/treatment Phase
Severe Sepsis Drug: Placebo Drug: Hydrocortisone Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Placebo-controlled, Randomised, Double-blind Study to Investigate the Efficacy and Safety of Low Dose Hydrocortisone to Prevent the Development of Septic Shock in Patients With Severe Sepsis
Study Start Date : January 2009
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013


Arm Intervention/treatment
Experimental: Hydrocortisone Drug: Hydrocortisone
50 mg loading dose, continuous infusion of 200 mg/d for 5 d, 100 mg/d for 2d, 50 mg/d for 2 d, and 25 mg/d for 2 d.

Placebo Comparator: Placebo Drug: Placebo
Application is identical to experimental arm




Primary Outcome Measures :
  1. Septic shock [ Time Frame: 14 days ]

Secondary Outcome Measures :
  1. Mortality [ Time Frame: 28, 90, and 180 days; ICU and hospital ]
  2. Length of stay [ Time Frame: ICU and hospital (3-6 months) ]
  3. Time to death [ Time Frame: 28, 90, and 180 days ]
  4. Time to septic shock [ Time Frame: 14 days ]
  5. Mechanical ventilation [ Time Frame: until ICU discharge ]
  6. Renal replacement therapy [ Time Frame: until ICU discharge ]
  7. Organ dysfunction (SOFA score) [ Time Frame: until ICU discharge but day 14 at maximum ]
  8. Frequency of weaning failure [ Time Frame: until ICU discharge ]
  9. Frequency and severity of muscle weakness [ Time Frame: until ICU discharge ]
  10. Frequency of gastrointestinal bleeding [ Time Frame: 28 days ]
  11. Frequency of secondary infections [ Time Frame: 28 days ]
  12. Delir [ Time Frame: ICU discharge ]
  13. Hypernatremia [ Time Frame: 14 days ]
  14. Hyperglycemia [ Time Frame: 14 days ]
  15. Other adverse events [ Time Frame: 28 days ]
  16. Posttraumatic stress disorder / health-related quality of life [ Time Frame: Hosptal discharge and 180 days after hospital discharge ]
  17. Immune response to hydrocortisone [ Time Frame: 6 days ]
  18. Adrenal function [ Time Frame: baseline ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Severe sepsis according to ACCP/CCM criteria
  • Onset of severe sepsis < 48 hours
  • Informed consent
  • Effective contraception in fertile women

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00670254


Locations
Show Show 30 study locations
Sponsors and Collaborators
Charite University, Berlin, Germany
German Federal Ministry of Education and Research
SepNet - Critical Care Trials Group
Coordination Centre for Clinical Trials Leipzig
Investigators
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Principal Investigator: Konrad Reinhart, MD University Hospital Jena; Dept. of Anesthesiology an Intensive Care Medicine
Study Chair: Didier Keh, MD Charité Universitaetsmedizin Berlin, Dept. of Anesthsiology and Intensive Care Medicine
Study Director: Frank M Brunkhorst, MD University Hospital Jena, Dept. of Anesthesiology and Intensive Care Medicine
Study Director: Markus Loeffler, MD University Leipzig, Coordination Center of Clinical Studies (KKSL)

Additional Information:
Publications:
Dellinger RP, Levy MM, Carlet JM, Bion J, Parker MM, Jaeschke R, Reinhart K, Angus DC, Brun-Buisson C, Beale R, Calandra T, Dhainaut JF, Gerlach H, Harvey M, Marini JJ, Marshall J, Ranieri M, Ramsay G, Sevransky J, Thompson BT, Townsend S, Vender JS, Zimmerman JL, Vincent JL; International Surviving Sepsis Campaign Guidelines Committee; American Association of Critical-Care Nurses; American College of Chest Physicians; American College of Emergency Physicians; Canadian Critical Care Society; European Society of Clinical Microbiology and Infectious Diseases; European Society of Intensive Care Medicine; European Respiratory Society; International Sepsis Forum; Japanese Association for Acute Medicine; Japanese Society of Intensive Care Medicine; Society of Critical Care Medicine; Society of Hospital Medicine; Surgical Infection Society; World Federation of Societies of Intensive and Critical Care Medicine. Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock: 2008. Crit Care Med. 2008 Jan;36(1):296-327. Erratum in: Crit Care Med. 2008 Apr;36(4):1394-6.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Didier Keh, MD, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00670254    
Other Study ID Numbers: HYPRESS
01KG0701 ( Other Identifier: BMBF )
2007-004401-10 ( EudraCT Number )
First Posted: May 1, 2008    Key Record Dates
Last Update Posted: September 27, 2013
Last Verified: September 2013
Keywords provided by Didier Keh, Charite University, Berlin, Germany:
Sepsis
Septic
Shock
Glucocorticoids
Hydrocortisone
Additional relevant MeSH terms:
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Sepsis
Shock, Septic
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Anti-Inflammatory Agents