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Hydrocortisone for Prevention of Septic Shock (HYPRESS)

This study has been completed.
Sponsor:
Collaborators:
German Federal Ministry of Education and Research
German Competence Network Sepsis
Coordination Centre for Clinical Trials Leipzig
Information provided by (Responsible Party):
Didier Keh, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00670254
First received: April 29, 2008
Last updated: September 26, 2013
Last verified: September 2013
  Purpose

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 Intervention Phase
Severe Sepsis
Drug: Placebo
Drug: Hydrocortisone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Septic shock [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mortality [ Time Frame: 28, 90, and 180 days; ICU and hospital ] [ Designated as safety issue: No ]
  • Length of stay [ Time Frame: ICU and hospital (3-6 months) ] [ Designated as safety issue: No ]
  • Time to death [ Time Frame: 28, 90, and 180 days ] [ Designated as safety issue: No ]
  • Time to septic shock [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Mechanical ventilation [ Time Frame: until ICU discharge ] [ Designated as safety issue: No ]
  • Renal replacement therapy [ Time Frame: until ICU discharge ] [ Designated as safety issue: No ]
  • Organ dysfunction (SOFA score) [ Time Frame: until ICU discharge but day 14 at maximum ] [ Designated as safety issue: No ]
  • Frequency of weaning failure [ Time Frame: until ICU discharge ] [ Designated as safety issue: Yes ]
  • Frequency and severity of muscle weakness [ Time Frame: until ICU discharge ] [ Designated as safety issue: Yes ]
  • Frequency of gastrointestinal bleeding [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Frequency of secondary infections [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Delir [ Time Frame: ICU discharge ] [ Designated as safety issue: Yes ]
  • Hypernatremia [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
  • Hyperglycemia [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
  • Other adverse events [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Posttraumatic stress disorder / health-related quality of life [ Time Frame: Hosptal discharge and 180 days after hospital discharge ] [ Designated as safety issue: No ]
  • Immune response to hydrocortisone [ Time Frame: 6 days ] [ Designated as safety issue: No ]
  • Adrenal function [ Time Frame: baseline ] [ Designated as safety issue: No ]

Enrollment: 380
Study Start Date: January 2009
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00670254

Locations
Germany
Universitaetsklinikum Aachen, Operative Intensivmedizin Erwachsene
Aachen, Germany, 52074
Zentralklinik Bad Berka GmbH, Zentrum für Anaesthesie, Intensivtherapie und Notfallmedizin
Bad Berka, Germany, 99437
HELIOS Klinikum Bad Saarow; Zentrum für Anaesthesiologie, Intensivmedizin, Notfallmedizin und Schmerztherapie
Bad Saarow, Germany, 15526
Vivantes Klinikum-Neukoelln, Klinik fuer Anaesthesie, operative Intensivmedizin und Schmerztherapie
Berlin, Germany, 12351
Charité Universitaetsmedizin Berlin, Campus Virchow-Klinikum und Campus Mitte, Med. Klinik mit Schwerpunkt Infektiologie und Pneumologie
Berlin, Germany, 13353
Charité Universitätsmedizin Berlin, Campus Virchow-Klinikum, Med. Klinik mit Schwerpunkt Nephrologie und internistische Intensivmedizin
Berlin, Germany, 13353
Helios Klinikum Berlin Buch, Klinik für Intensivmedizin
Berlin, Germany, 13125
St. Joseph Krankenhaus, Institut fue Anaesthesie, Schwerpunkt operative Intensivmedizin und SchmerztherapieAnaesthesie, operative Intensiv- und Notfallmedizin
Berlin, Germany, 12101
Vivantes Auguste-Viktoria-Klinikum, Klinik fuer Anaesthesiologie, Intensivmedizin und Schmerztherapie
Berlin, Germany, 12157
Vivantes Humboldt-Klinikum, Klinik für Innere Medizin - Kardiologie und konservative Intensivmedizin
Berlin, Germany, 13509
Vivantes Klinikum Hellersdorf, Klinik fuer Anaesthesie, operative Intensivmedizin und Schmerztherapie
Berlin, Germany, 12621
Vivantes Klinikum Neukoelln,Klinik fuer Innere Medizin, Kardiologie und konservative Intensivmedizin
Berlin, Germany, 12351
Charité Universitaetsmedizin Berlin, Campus Virchow-Klinikum und Mitte Klinik für Anaesthesiologie und operative Intensivmedizin
Berlin, Germany, 13353
Rheinische Friedrich-Wilhelms-Universitaet, Klinik für Anaesthesiologie und Operative Intensivmedizin
Bonn, Germany, 53105
Krankenhaus Dresden-Friedrichstadt, Klinik für Anaesthesiologie und Intensivmedizin
Dresden, Germany, 01067
Universitaetsklinik Carl Gustav Carus Dresden
Dresden, Germany, 01307
Helios Klinikum Erfurt, Klinik fuer Anaesthesie, Intensivmedizin und Schmerztherapie
Erfurt, Germany, 99089
Universitaetsklinikum Freiburg, Anaesthesiologische Universitaetsklinik - Abteilung Anaesthesiologie und Intensivtherapie
Freiburg, Germany, 79106
Ernst Moritz Arndt Universitaet Greifswald, Klinik und Poliklinik für Anaesthesiologie und Intensivmedizin
Greifswald, Germany, 17475
Krankenhaus Martha-Maria Halle-Doelau GmbH
Halle (Saale), Germany, 06120
Medizinische Fakultaet der Martin-Luther-Universitaet Halle-Wittenberg - Universitaetsklinikum Halle (Saale)
Halle (Saale), Germany, 06097
Universitaetsklinikum Hamburg-Eppendorf, Klinik für Intensivmedizin
Hamburg, Germany, 20246
Klinikum Heidenheim, Klinik für Anaesthesiologie und operative Intensivmedizin
Heidenheim, Germany, 89522
Klinik Henningsdorf der Oberhavel-Kliniken GmbH, Abteilung für Anaesthesie und Intensivmedizin
Henningsdorf, Germany, 16716
Friedrich Schiller Universität, Klinik für Anaesthesiologie und Intensivmedizin
Jena, Germany, 07747
Universitaetsklinikum Schleswig Holstein Campus Kiel, Klinik für Anaesthesiologie und Operative Intensivmedizin
Kiel, Germany, 24105
St. Elisabeth-Krankenhaus Köln-Hohenlind, Klinik für Anaesthesiologie und operative Intensivmedizin
Koeln, Germany, 50935
Kliniken der Stadt Koeln - Krankenhaus Merheim, Klinik für Anaesthesiologie und operative Intensivmedizin
Koeln, Germany, 51058
Universitaetsklinikum Leipzig AöR, Klinik und Poliklinik für Anaesthesiologie und Intensivtherapie
Leipzig, Germany, 04103
Klinikum Oldenburg GmbH, Klinik fuer Anaesthesiologie, Intensivmedizin, Notfallmedizin und Schmerztherapie
Oldenburg, Germany, 26133
Sponsors and Collaborators
Charite University, Berlin, Germany
German Federal Ministry of Education and Research
German Competence Network Sepsis
Coordination Centre for Clinical Trials Leipzig
Investigators
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)
  More Information

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.

Responsible Party: Didier Keh, MD, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00670254     History of Changes
Other Study ID Numbers: HYPRESS, 01KG0701, 2007-004401-10
Study First Received: April 29, 2008
Last Updated: September 26, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:
Sepsis
Septic
Shock
Glucocorticoids
Hydrocortisone

Additional relevant MeSH terms:
Sepsis
Shock, Septic
Infection
Inflammation
Pathologic Processes
Shock
Systemic Inflammatory Response Syndrome
Cortisol succinate
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Dermatologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014