Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE April 29, 2008
First Posted Date  ICMJE May 1, 2008
Last Update Posted Date September 27, 2013
Study Start Date  ICMJE January 2009
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2008)
Septic shock [ Time Frame: 14 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00670254 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 18, 2009)
  • Mortality [ Time Frame: 28, 90, and 180 days; ICU and hospital ]
  • Length of stay [ Time Frame: ICU and hospital (3-6 months) ]
  • Time to death [ Time Frame: 28, 90, and 180 days ]
  • Time to septic shock [ Time Frame: 14 days ]
  • Mechanical ventilation [ Time Frame: until ICU discharge ]
  • Renal replacement therapy [ Time Frame: until ICU discharge ]
  • Organ dysfunction (SOFA score) [ Time Frame: until ICU discharge but day 14 at maximum ]
  • Frequency of weaning failure [ Time Frame: until ICU discharge ]
  • Frequency and severity of muscle weakness [ Time Frame: until ICU discharge ]
  • Frequency of gastrointestinal bleeding [ Time Frame: 28 days ]
  • Frequency of secondary infections [ Time Frame: 28 days ]
  • Delir [ Time Frame: ICU discharge ]
  • Hypernatremia [ Time Frame: 14 days ]
  • Hyperglycemia [ Time Frame: 14 days ]
  • Other adverse events [ Time Frame: 28 days ]
  • Posttraumatic stress disorder / health-related quality of life [ Time Frame: Hosptal discharge and 180 days after hospital discharge ]
  • Immune response to hydrocortisone [ Time Frame: 6 days ]
  • Adrenal function [ Time Frame: baseline ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2008)
  • Mortality [ Time Frame: 28, 90, and 180 days; ICU and hospital ]
  • Length of stay [ Time Frame: ICU and hospital ]
  • Time to death [ Time Frame: 28, 90, and 180 days ]
  • Time to septic shock [ Time Frame: 14 days ]
  • Mechanical ventilation [ Time Frame: until ICU discharge ]
  • Renal replacement therapy [ Time Frame: until ICU discharge ]
  • Organ dysfunction (SOFA score) [ Time Frame: until ICU discharge but day 14 at maximum ]
  • Frequency of weaning failure [ Time Frame: until ICU discharge ]
  • Frequency and severity of muscle weakness [ Time Frame: until ICU discharge ]
  • Frequency of gastrointestinal bleeding [ Time Frame: 28 days ]
  • Frequency of secondary infections [ Time Frame: 28 days ]
  • Delir [ Time Frame: ICU discharge ]
  • Hypernatremia [ Time Frame: 14 days ]
  • Hyperglycemia [ Time Frame: 14 days ]
  • Other adverse events [ Time Frame: 28 days ]
  • Posttraumatic stress disorder / health-related quality of life [ Time Frame: Hosptal discharge and 180 days after hospital discharge ]
  • Immune response to hydrocortisone [ Time Frame: 6 days ]
  • Adrenal function [ Time Frame: baseline ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hydrocortisone for Prevention of Septic Shock
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Severe Sepsis
Intervention  ICMJE
  • Drug: Placebo
    Application is identical to experimental arm
  • 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.
Study Arms  ICMJE
  • Experimental: Hydrocortisone
    Intervention: Drug: Hydrocortisone
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 29, 2008)
380
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00670254
Other Study ID Numbers  ICMJE HYPRESS
01KG0701 ( Other Identifier: BMBF )
2007-004401-10 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Didier Keh, Charite University, Berlin, Germany
Study Sponsor  ICMJE Charite University, Berlin, Germany
Collaborators  ICMJE
  • German Federal Ministry of Education and Research
  • SepNet - Critical Care Trials Group
  • Coordination Centre for Clinical Trials Leipzig
Investigators  ICMJE
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)
PRS Account Charite University, Berlin, Germany
Verification Date September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP