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Hydrocortisone for Prevention of Septic Shock (HYPRESS)
This study is currently recruiting participants.
Verified July 2011 by Charite University, Berlin, Germany

First Received on April 29, 2008.   Last Updated on July 19, 2011   History of Changes
Sponsor: Charite University, Berlin, Germany
Collaborators: German Federal Ministry of Education and Research
German Competence Network Sepsis
Coordination Center for Clinical Studies Leipzig (KKSL)
Information provided by: Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00670254
  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 III

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:

MedlinePlus related topics: Sepsis Shock
Drug Information available for: Hydrocortisone acetate Hydrocortisone Proctofoam-HC Hydrocortisone hemisuccinate Hydrocortamate Hydrocortisone 21-sodium succinate Hydrocortisone cypionate Cortisol succinate Cortisol 21-phosphate
U.S. FDA Resources

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 ]

Estimated Enrollment: 380
Study Start Date: January 2009
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: October 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00670254

Contacts
Contact: Didier Keh, MD ++49 30 450 651048 didier.keh@charite.de
Contact: Frank M Brunkhorst, MD +49 3641 9323383 frank.brunkhorst@med.uni-jena.de

Locations
Germany
Universitaetsklinikum Aachen, Operative Intensivmedizin Erwachsene Recruiting
Aachen, Germany, 52074
Contact: Gernot Marx, MD     +49 241 8080444     gmarx@ukaachen.de    
Zentralklinik Bad Berka GmbH, Zentrum für Anästhesie, Intensivtherapie und Notfallmedizin Recruiting
Bad Berka, Germany, 99437
Contact: Lars Hüter, MD     +49 36458 51001     lars.hueter@zentralklinik.de    
HELIOS Klinikum Bad Saarow; Zentrum für Anästhesiologie, Intensivmedizin, Notfallmedizin und Schmerztherapie Recruiting
Bad Saarow, Germany, 15526
Contact: Stefan P Wirtz, MD     +49 33631 73181     stefan.wirtz@helios-kliniken.de    
Charité Universitätsmedizin Berlin, Campus Virchow-Klinikum, Med. Klinik mit Schwerpunkt Nephrologie und internistische Intensivmedizin Recruiting
Berlin, Germany, 13353
Contact: Michael Oppert, MD     +49 30 450 665516     michael.oppert@charite.de    
Charité Universitaetsmedizin Berlin, Campus Virchow-Klinikum und Campus Mitte, Med. Klinik mit Schwerpunkt Infektiologie und Pneumologie Terminated
Berlin, Germany, 13353
Vivantes Klinikum Hellersdorf, Klinik fuer Anaesthesie, operative Intensivmedizin und Schmerztherapie Terminated
Berlin, Germany, 12621
St. Joseph Krankenhaus, Klinik fuer Anaesthesie, operative Intensiv- und Notfallmedizin Recruiting
Berlin, Germany, 12101
Contact: Martin Schmutzler, MD     +49 30 78822384     dr.schmutzler@t-online.de    
Vivantes Klinikum-Neukoelln, Klinik fuer Anaesthesie, operative Intensivmedizin und Schmerztherapie Recruiting
Berlin, Germany, 12351
Contact: Herwig Gerlach, MD     +49 30 130142011     herwig.gerlach@vivantes.de    
Vivantes Klinikum Neukoelln,Klinik fuer Anaesthesie, operative Intensivmedizin und Schmerztherapie Recruiting
Berlin, Germany, 12351
Contact: Harald Darius, MD     +49 30 130142361     harald.darius@vivantes.de    
Vivantes Humboldt-Klinikum, Klinik für Innere Medizin - Kardiologie und konservative Intensivmedizin Terminated
Berlin, Germany, 13509
Charité Universitaetsmedizin Berlin, Campus Virchow-Klinikum und Mitte Klinik für Anaesthesiologie und operative Intensivmedizin Recruiting
Berlin, Germany, 13353
Contact: Didier Keh, MD     +49 30 450 651048     didier.keh@charite.de    
Helios Klinikum Berlin Buch, Klinik für Intensivmedizin Recruiting
Berlin, Germany, 13125
Contact: Kerstin Resener, MD     +49 30 940113105     kerstin.resener@helios-kliniken.de    
Vivantes Auguste-Viktoria-Klinikum, Klinik fuer Anaesthesiologie, Intensivmedizin und Schmerztherapie Terminated
Berlin, Germany, 12157
Vivantes Humboldt Klinikum, Klink fuer Anaesthesie, opertaive Intensivmedizin und Schmerztherapie Withdrawn
Berlin, Germany, 13509
Rheinische Friedrich-Wilhelms-Universitaet, Klinik für Anaesthesiologie und Operative Intensivmedizin Recruiting
Bonn, Germany, 53105
Contact: Christian Putensen, MD     +49 228 28714118     Putensen@uni-bonn.de    
Krankenhaus Dresden-Friedrichstadt, Klinik für Anaesthesiologie und Intensivmedizin Terminated
Dresden, Germany, 01067
Universitaetsklinik Carl Gustav Carus Dresden Recruiting
Dresden, Germany, 01307
Contact: Maximilian Ragaller, MD     +49 351 4582785     maximillian.ragaller@uniklinikum-dresden.de    
Helios Klinikum Erfurt, Klinik fuer Anaesthesie, Intensivmedizin und Schmerztherapie Recruiting
Erfurt, Germany, 99089
Contact: Andreas Meier-Hellmann, MD     +49 361 7816076     andreas.meier-hellmann@helios-kliniken.de    
Universitaetsklinikum Freiburg, Anaesthesiologische Universitaetsklinik - Abteilung Anaesthesiologie und Intensivtherapie Recruiting
Freiburg, Germany, 79106
Contact: René Schmidt, MD     +49 761 2702315     kopp@ana1.ukl.uni-freiburg.de    
Ernst Moritz Arndt Universitaet Greifswald Recruiting
Greifswald, Germany, 17475
Contact: Matthias Gruendling, MD     +49 383 4865810     gruendli@uni-greifswald.de    
Krankenhaus Martha-Maria Halle-Doelau GmbH Recruiting
Halle (Saale), Germany, 06120
Contact: Harald Fritz, MD     +49 345 5591255     h.fritz@marthamaria-halle.de    
Medizinische Fakultaet der Martin-Luther-Universitaet Halle-Wittenberg - Universitaetsklinikum Halle (Saale) Recruiting
Halle (Saale), Germany, 06097
Contact: Michael Bucher, MD     +49 345 5572322     michael.bucher@medizin.uni-halle.de    
Universitaetsklinikum Hamburg-Eppendorf, Klinik für Intensivmedizin Recruiting
Hamburg, Germany, 20246
Contact: Axel Nierhaus, MD     +49 40 428037010     nierhaus@uke.de    
Universitaetsklinikum Heidelberg, Innere Medizin IV: Gastroenterologie, Infektionskrankheiten, Vergiftungen Withdrawn
Heidelberg, Germany, 69120
Klinikum Heidenheim, Klinik für Anaesthesiologie und operative Intensivmedizin Recruiting
Heidenheim, Germany, 89522
Contact: Alexander Brinkmann, MD     +49 7321 332212     alexander.brinkmann@kliniken-heidenheim.de    
Klinik Henningsdorf der Oberhavel-Kliniken GmbH, Abteilung für Anaesthesie und Intensivmedizin Terminated
Henningsdorf, Germany, 16716
Universitätsklinikum des Saarlandes Withdrawn
Homburg/Saar, Germany, 66421
Friedrich Schiller Universität, Klinik für Anaesthesiologie und Intensivmedizin Recruiting
Jena, Germany, 07747
Contact: Konrad Reinhart, MD     +49 341 9323102     konrad.reinhart@med.uni-jena.de    
Klinikum Hildesheim GmbH, Klinik für Anaesthesiologie und Operative Intensivmedizin Recruiting
Kiel, Germany, 24105
Contact: Norbert Weiler, MD     +49 431 5972991     weiler@anaesthesie.uni-kiel.de    
Kliniken der Stadt Koeln - Krankenhaus Merheim, Klinik für Anaesthesiologie und operative Intensivmedizin Recruiting
Koeln, Germany, 51058
Contact: Frank Wappler, MD     +49 221 89073863     wapplerf@kliniken-koeln.de    
Klinikum der Universitaet zu Koeln, Medizinische Klinik I: Innere Medizin Withdrawn
Koeln, Germany, 50294
St. Elisabeth-Krankenhaus Köln-Hohenlind, Klinik für Anaesthesiologie und operative Intensivmedizin Recruiting
Koeln, Germany, 50935
Contact: Fritz Fiedler, MD     +49 221 46771701     fritz.fiedler@hohenlind.de    
Universitaetsklinikum Leipzig AöR, Klinik für Anaesthesiologie und operative Intensivmedizin Recruiting
Leipzig, Germany, 04103
Contact: Sven Bercker, MD     +49 341 9717704     sven.bercker@uniklinik-leipzig.de    
Universitaetsklinikum Mannheim, I. Medizinische Klinik: Kardiologie, Angiologie, Pneumologie Withdrawn
Mannheim, Germany, 68167
Universitaetsklinikum Mannheim, Klinik für Anaesthesiologie und operative Intensivmedizin Withdrawn
Mannheim, Germany, 68167
Universitaetsklinikum Giessen und Marburg GmbH, Standort Marburg, Klinik für Innere Medizin, Schwerpunkt Pneumologie Withdrawn
Marburg, Germany, 35043
Klinikum Nuernberg-Nord, Klinik für Anaesthesiologie und operative Intensivmedizin Withdrawn
Nuernberg, Germany, 90419
Klinikum Ernst von Bergmann GmbH, Klinik für Anaesthesie und Intensivtherapie Withdrawn
Potsdam, Germany, 14467
Rostock Universitaetsklinikum, Klinik und Poliklinik für Anaesthesiologie und Intensivtherapie Withdrawn
Rostock, Germany, 18057
Universitaetsklinikum Ulm, Klinik für Anaesthesiologie Withdrawn
Ulm, Germany, 89075
Sponsors and Collaborators
Charite University, Berlin, Germany
German Federal Ministry of Education and Research
German Competence Network Sepsis
Coordination Center for Clinical Studies Leipzig (KKSL)
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:
Competence Network Sepsis (SepNet)  This link exits the ClinicalTrials.gov site

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.
Reinhart K, Brunkhorst F, Bone H, Gerlach H, Gründling M, Kreymann G, Kujath P, Marggraf G, Mayer K, Meier-Hellmann A, Peckelsen C, Putensen C, Quintel M, Ragaller M, Rossaint R, Stüber F, Weiler N, Welte T, Werdan K; Deutschen Interdisziplinären Vereinigung für Intensiv- und Notfallmedizin (DIVI); Deutschen Sepsis-Gesellschaft e.V. (DSG). [Diagnosis and therapy of sepsis. Guidelines of the German Sepsis Society Inc. and the German Interdisciplinary Society for Intensive and Emergency Medicine] Internist (Berl). 2006 Apr;47(4):356, 358-60, 362-8, passim. Review. German.
Engel C, Brunkhorst FM, Bone HG, Brunkhorst R, Gerlach H, Grond S, Gruendling M, Huhle G, Jaschinski U, John S, Mayer K, Oppert M, Olthoff D, Quintel M, Ragaller M, Rossaint R, Stuber F, Weiler N, Welte T, Bogatsch H, Hartog C, Loeffler M, Reinhart K. Epidemiology of sepsis in Germany: results from a national prospective multicenter study. Intensive Care Med. 2007 Apr;33(4):606-18. Epub 2007 Feb 24.
Sprung CL, Annane D, Keh D, Moreno R, Singer M, Freivogel K, Weiss YG, Benbenishty J, Kalenka A, Forst H, Laterre PF, Reinhart K, Cuthbertson BH, Payen D, Briegel J; CORTICUS Study Group. Hydrocortisone therapy for patients with septic shock. N Engl J Med. 2008 Jan 10;358(2):111-24.
Annane D, Bellissant E, Bollaert PE, Briegel J, Keh D, Kupfer Y. Corticosteroids for treating severe sepsis and septic shock. Cochrane Database Syst Rev. 2004;(1):CD002243. Review.
Keh D, Boehnke T, Weber-Cartens S, Schulz C, Ahlers O, Bercker S, Volk HD, Doecke WD, Falke KJ, Gerlach H. Immunologic and hemodynamic effects of "low-dose" hydrocortisone in septic shock: a double-blind, randomized, placebo-controlled, crossover study. Am J Respir Crit Care Med. 2003 Feb 15;167(4):512-20. Epub 2002 Nov 8.
[No authors listed] American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference: definitions for sepsis and organ failure and guidelines for the use of innovative therapies in sepsis. Crit Care Med. 1992 Jun;20(6):864-74. Review.

Responsible Party: Didier Keh, MD, Charite, Dept. of Anesthesiology and Intensive Care Medicine
ClinicalTrials.gov Identifier: NCT00670254     History of Changes
Other Study ID Numbers: HYPRESS, BMBF grant: 01KG0701, EudraCT-No: 2007-004401-10
Study First Received: April 29, 2008
Last Updated: July 19, 2011
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
Toxemia
Shock
Shock, Septic
Infection
Systemic Inflammatory Response Syndrome
Inflammation
 Pathologic Processes
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012



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