Hydrocortisone for Prevention of Septic Shock
Information source: Charite University, Berlin, Germany
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Severe Sepsis
Intervention: Placebo (Drug); Hydrocortisone (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Charite University, Berlin, Germany Official(s) and/or principal investigator(s):
Konrad Reinhart, MD, Principal Investigator, Affiliation: University Hospital Jena; Dept. of Anesthesiology an Intensive Care Medicine
Didier Keh, MD, Study Chair, Affiliation: Charité Universitaetsmedizin Berlin, Dept. of Anesthsiology and Intensive Care Medicine
Frank M Brunkhorst, MD, Study Director, Affiliation: University Hospital Jena, Dept. of Anesthesiology and Intensive Care Medicine
Markus Loeffler, MD, Study Director, Affiliation: University Leipzig, Coordination Center of Clinical Studies (KKSL)
Overall contact:
Didier Keh, MD, Phone: ++49 30 450 651048, Email: didier.keh@charite.de
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.
Clinical Details
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 design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Septic shock
Secondary outcome: MortalityLength of stay Time to death Time to septic shock Mechanical ventilation Renal replacement therapy Organ dysfunction (SOFA score) Frequency of weaning failure Frequency and severity of muscle weakness Frequency of gastrointestinal bleeding Frequency of secondary infections Delir Hypernatremia Hyperglycemia Other adverse events Posttraumatic stress disorder / health-related quality of life Immune response to hydrocortisone Adrenal function
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Didier Keh, MD, Phone: ++49 30 450 651048, Email: didier.keh@charite.de
Friedrich Schiller Universität, Klinik für Anaesthesiologie und Intensivmedizin, Jena 07747, Germany; Recruiting
Konrad Reinhart, MD, Phone: +49 341 9323102, Email: konrad.reinhart@med.uni-jena.de
Charité Universitaetsmedizin Berlin, Campus Virchow-Klinikum und Mitte Klinik für Anaesthesiologie und operative Intensivmedizin, Berlin 13353, Germany; Recruiting
Didier Keh, MD, Phone: +49 30 450 651048, Email: didier.keh@charite.de
Universitaetsklinikum Aachen, Operative Intensivmedizin Erwachsene, Aachen 52074, Germany; Recruiting
Rolf Dembinski, MD, Phone: +49 241 8080444, Email: rolf.dembinski@post.rwth-aachen.de
Charité Universitätsmedizin Berlin, Campus Virchow-Klinikum, Med. Klinik mit Schwerpunkt Nephrologie und internistische Intensivmedizin, Berlin 13353, Germany; Recruiting
Michael Oppert, MD, Phone: +49 30 450 665516, Email: michael.oppert@charite.de
Charité Universitaetsmedizin Berlin, Campus Virchow-Klinikum, Klinik fuer Allgemein-, Visceral- und Transplantationsmedizin, Berlin 13353, Germany; Recruiting
Henneberg Thomas, MD, Phone: +49 30 450 652103, Email: thomas.henneberg@charite.de
Charité Universitaetsmedizin Berlin, Campus Virchow-Klinikum und Campus Mitte, Med. Klinik mit Schwerpunkt Infektiologie und Pneumologie, Berlin 13353, Germany; Recruiting
Simone Rosseau, MD, Phone: +49 30 450 653365, Email: simone.rosseau@charite.de
Vivantes Humboldt-Klinikum, Klinik für Innere Medizin - Kardiologie und konservative Intensivmedizin, Berlin 13509, Germany; Recruiting
Glenn Zachow, MD, Phone: +49 30 41941488, Email: glenn.zachow@vivantes.de
Vivantes Auguste-Viktoria-Klinikum, Klinik fuer Anaesthesiologie, Intensivmedizin und Schmerztherapie, Berlin 12157, Germany; Recruiting
Peter Lehmkuhl, MD, Phone: +49 30 797403, Email: peter.lehmkuhl@vivantes.de
Vivantes Klinikum-Neukoelln, Klinik fuer Anaesthesie, operative Intensivmedizin und Schmerztherapie, Berlin 12351, Germany; Recruiting
Herwig Gerlach, MD, Phone: +49 30 60042361, Email: herwig.gerlach@vivantes.de
Vivantes Klinikum Neukoelln,Klinik fuer Anaesthesie, operative Intensivmedizin und Schmerztherapie, Berlin 12351, Germany; Recruiting
Harald Darius, MD, Phone: +49 30 60042011, Email: harald.darius@vivantes.de
Vivantes Klinikum Hellersdorf, Klinik fuer Anaesthesie, operative Intensivmedizin und Schmerztherapie, Berlin 12621, Germany; Recruiting
Ines Ziegler, MD, Phone: +49 30 56512186, Email: ines.ziegler@vivantes.de
Vivantes Humboldt Klinikum, Klink fuer Anaesthesie, opertaive Intensivmedizin und Schmerztherapie, Berlin 13509, Germany; Recruiting
Rainer Kuehnemund, MD, Phone: +49 30 41941311, Email: rainer.kuehnemund@vivantes.de
Helios Klinikum Berlin Buch, Klinik für Intensivmedizin, Berlin 13125, Germany; Recruiting
Ralf Kuhlen, MD, Phone: +49 30 94017090, Email: ralf.kuhlen@helios-kliniken.de
St. Joseph Krankenhaus, Klinik fuer Anaesthesie, operative Intensiv- und Notfallmedizin, Berlin 12101, Germany; Recruiting
Martin Schmutzler, MD, Phone: +49 30 78822384, Email: dr.schmutzler@t-online.de
Rheinische Friedrich-Wilhelms-Universitaet, Klinik für Anaesthesiologie und Operative Intensivmedizin, Bonn 53105, Germany; Recruiting
Christian Putensen, MD, Phone: +49 228 28714118, Email: Putensen@uni-bonn.de
Krankenhaus Dresden-Friedrichstadt, Klinik für Anaesthesiologie und Intensivmedizin, Dresden 01067, Germany; Recruiting
Karl F Rothe, MD, Phone: +49 351 4801170, Email: schoenherr-co@khdf.de
Universitaetsklinik Carl Gustav Carus Dresden, Dresden 01307, Germany; Recruiting
Maximilian Ragaller, MD, Phone: +49 351 4582785, Email: ragaller@rcs.urz.tu-dresden.de
Helios Klinikum Erfurt, Klinik fuer Anaesthesie, Intensivmedizin und Schmerztherapie, Erfurt 99089, Germany; Recruiting
Andreas Meier-Hellmann, MD, Phone: +49 361 7816076, Email: andreas.meier-hellmann@helios-kliniken.de
Universitaetsklinikum Freiburg, Anaesthesiologische Universitaetsklinik - Abteilung Anaesthesiologie und Intensivtherapie, Freiburg 79106, Germany; Recruiting
Karl-Heinz Kopp, MD, Phone: +49 761 2702315, Email: kopp@ana1.ukl.uni-freiburg.de
Ernst Moritz Arndt Universitaet Greifswald, Greifswald 17475, Germany; Recruiting
Matthias Gruendling, MD, Phone: +49 383 4865810, Email: gruendli@uni-greifswald.de
Krankenhaus Martha-Maria Halle-Doelau GmbH, Halle (Saale) 06120, Germany; Recruiting
Harald Fritz, MD, Phone: +49 345 5591255, Email: h.fritz@marthamaria-halle.de
Medizinische Fakultaet der Martin-Luther-Universitaet Halle-Wittenberg - Universitaetsklinikum Halle (Saale), Halle (Saale) 06097, Germany; Recruiting
Joachim Radke, MD, Phone: +49 345 5572322, Email: anaesthesie@medizin.uni-halle.de
Universitaetsklinikum Hamburg-Eppendorf, Klinik für Intensivmedizin, Hamburg 20246, Germany; Recruiting
Axel Nierhaus, MD, Phone: +49 40 428037010, Email: nierhaus@uke.de
Universitaetsklinikum Heidelberg, Innere Medizin IV: Gastroenterologie, Infektionskrankheiten, Vergiftungen, Heidelberg 69120, Germany; Recruiting
Jens Encke, MD, Email: jens.encke@med.uni-heidelberg.de
Klinikum Heidenheim, Klinik für Anaesthesiologie und operative Intensivmedizin, Heidenheim 89522, Germany; Recruiting
Alexander Brinkmann, MD, Phone: +49 7321 332212, Email: alexander.brinkmann@kliniken-heidenheim.de
Klinik Henningsdorf der Oberhavel-Kliniken GmbH, Abteilung für Anaesthesie und Intensivmedizin, Henningsdorf 16716, Germany; Recruiting
Andreas Lange, MD, Phone: +49 330 25454100, Email: lange@oberhavel-kliniken.de
Klinikum Hildesheim GmbH, Klinik für Anaesthesiologie und Operative Intensivmedizin, Kiel 24105, Germany; Recruiting
Norbert Weiler, MD, Phone: +49 431 5972991, Email: weiler@anaesthesie.uni-kiel.de
Klinikum der Universitaet zu Koeln, Medizinische Klinik I: Innere Medizin, Koeln 50294, Germany; Recruiting
Matthias Kochanek, MD, Phone: +49 221 47885299, Email: ail27@uni-koeln.de
Kliniken der Stadt Koeln - Krankenhaus Merheim, Klinik für Anaesthesiologie und operative Intensivmedizin, Koeln 51058, Germany; Recruiting
Frank Wappler, MD, Phone: +49 221 89073863, Email: wapplerf@kliniken-koeln.de
St. Elisabeth-Krankenhaus Köln-Hohenlind, Klinik für Anaesthesiologie und operative Intensivmedizin, Koeln 50935, Germany; Recruiting
Fritz Fiedler, MD, Phone: +49 221 46771701, Email: fritz.fiedler@hohenlind.de
Universitaetsklinikum Leipzig AöR, Klinik für Anaesthesiologie und operative Intensivmedizin, Leipzig 04103, Germany; Recruiting
Thorsten Albert, MD, Phone: +49 341 971770, Email: thorsten.albert@uniklinik-leipzig.de
Universitaetsklinikum Mannheim, I. Medizinische Klinik: Kardiologie, Angiologie, Pneumologie, Mannheim 68167, Germany; Recruiting
Ursula Hoffmann, MD, Phone: +49 621 3852030, Email: ursula.hoffmann@med.ma.uni-heidelberg.de
Universitaetsklinikum Mannheim, Klinik für Anaesthesiologie und operative Intensivmedizin, Mannheim 68167, Germany; Recruiting
Armin Kalenka, MD, Phone: +49 621 3832903, Email: armin.kalenka@anaes.ma.uni-heidelberg.de
Universitaetsklinikum Giessen und Marburg GmbH, Standort Marburg, Klinik für Innere Medizin, Schwerpunkt Pneumologie, Marburg 35043, Germany; Recruiting
Robert Bals, MD, Phone: +49 6421 2864994, Email: bals@mailer.uni-marburg.de
Klinikum Nuernberg-Nord, Klinik für Anaesthesiologie und operative Intensivmedizin, Nuernberg 90419, Germany; Recruiting
Dieter Heuser, MD, Phone: +49 911 3982646, Email: anaes_sek_n@klinikum-nuernberg.de
Klinikum Ernst von Bergmann GmbH, Klinik für Anaesthesie und Intensivtherapie, Potsdam 14467, Germany; Recruiting
Dirk Pappert, MD, Phone: +49 331 2415032, Email: dpappert@klinikumevb.de
Rostock Universitaetsklinikum, Klinik und Poliklinik für Anaesthesiologie und Intensivtherapie, Rostock 18057, Germany; Recruiting
Dierk Vagts, MD, Phone: +49 381 4946420, Email: dierk.vagts@med.uni-rostock.de
Universitaetsklinikum Ulm, Klinik für Anaesthesiologie, Ulm 89075, Germany; Recruiting
Manfred Weiss, MD, Phone: +49 731 50060226, Email: manfred.weiss@uniklinik-ulm.de
Additional Information
Competence Network Sepsis (SepNet) German Sepsis Society
Related 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.
Starting date: January 2009
Ending date: August 2011
Last updated: February 18, 2009
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