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Hydrocortisone for Prevention of Septic Shock

Information source: Charite University, Berlin, Germany
Information obtained from ClinicalTrials.gov on February 07, 2013
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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Septic shock

Secondary outcome:

Mortality

Length 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

Universitaetsklinikum Aachen, Operative Intensivmedizin Erwachsene, Aachen 52074, Germany; Recruiting
Gernot Marx, MD, Phone: +49 241 8080444, Email: gmarx@ukaachen.de

Zentralklinik Bad Berka GmbH, Zentrum für Anaesthesie, Intensivtherapie und Notfallmedizin, Bad Berka 99437, Germany; Recruiting
Lars Hüter, MD, Phone: +49 36458 51001, Email: lars.hueter@zentralklinik.de

HELIOS Klinikum Bad Saarow; Zentrum für Anaesthesiologie, Intensivmedizin, Notfallmedizin und Schmerztherapie, Bad Saarow 15526, Germany; Recruiting
Stefan P Wirtz, MD, Phone: +49 33631 73181, Email: stefan.wirtz@helios-kliniken.de

Charité Universitätsmedizin Berlin, Campus Virchow-Klinikum, Med. Klinik mit Schwerpunkt Nephrologie und internistische Intensivmedizin, Berlin 13353, Germany; Recruiting
Sibylle Rademacher, MD, Phone: +49 30 450 665516, Email: sibylle.rademacher@charite.de

Charité Universitaetsmedizin Berlin, Campus Virchow-Klinikum und Campus Mitte, Med. Klinik mit Schwerpunkt Infektiologie und Pneumologie, Berlin 13353, Germany; Terminated

Vivantes Humboldt-Klinikum, Klinik für Innere Medizin - Kardiologie und konservative Intensivmedizin, Berlin 13509, Germany; Recruiting
Josefa Lehmke, MD, Phone: +49 30 130121011, Email: josefa.lehmke@vivantes.de

St. Joseph Krankenhaus, Institut fue Anaesthesie, Schwerpunkt operative Intensivmedizin und SchmerztherapieAnaesthesie, operative Intensiv- und Notfallmedizin, Berlin 12101, Germany; Recruiting
Martin Schmutzler, MD, Phone: +49 30 78822384, Email: dr.schmutzler@t-online.de

Vivantes Klinikum-Neukoelln, Klinik fuer Anaesthesie, operative Intensivmedizin und Schmerztherapie, Berlin 12351, Germany; Recruiting
Herwig Gerlach, MD, Phone: +49 30 130142011, Email: herwig.gerlach@vivantes.de

Vivantes Klinikum Neukoelln,Klinik fuer Innere Medizin, Kardiologie und konservative Intensivmedizin, Berlin 12351, Germany; Terminated

Vivantes Klinikum Hellersdorf, Klinik fuer Anaesthesie, operative Intensivmedizin und Schmerztherapie, Berlin 12621, Germany; Terminated

Vivantes Humboldt Klinikum, Klink fuer Anaesthesie, opertaive Intensivmedizin und Schmerztherapie, Berlin 13509, Germany; Withdrawn

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

Vivantes Auguste-Viktoria-Klinikum, Klinik fuer Anaesthesiologie, Intensivmedizin und Schmerztherapie, Berlin 12157, Germany; Terminated

Helios Klinikum Berlin Buch, Klinik für Intensivmedizin, Berlin 13125, Germany; Recruiting
Kerstin Resener, MD, Phone: +49 30 940113105, Email: kerstin.resener@helios-kliniken.de

Rheinische Friedrich-Wilhelms-Universitaet, Klinik für Anaesthesiologie und Operative Intensivmedizin, Bonn 53105, Germany; Terminated

Krankenhaus Dresden-Friedrichstadt, Klinik für Anaesthesiologie und Intensivmedizin, Dresden 01067, Germany; Recruiting
Andreas Nowak, MD, Phone: +49 351 4801170, Email: nowak-an@khdf.de

Universitaetsklinik Carl Gustav Carus Dresden, Dresden 01307, Germany; Recruiting
Maximilian Ragaller, MD, Phone: +49 351 4582785, Email: maximillian.ragaller@uniklinikum-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; Terminated

Ernst Moritz Arndt Universitaet Greifswald, Klinik und Poliklinik für Anaesthesiologie und Intensivmedizin, Greifswald 17475, Germany; Recruiting
Matthias Gruendling, MD, Phone: +49 383 4865810, Email: gruendli@uni-greifswald.de

Medizinische Fakultaet der Martin-Luther-Universitaet Halle-Wittenberg - Universitaetsklinikum Halle (Saale), Halle (Saale) 06097, Germany; Recruiting
Michael Bucher, MD, Phone: +49 345 5572322, Email: michael.bucher@uk-halle.de

Krankenhaus Martha-Maria Halle-Doelau GmbH, Halle (Saale) 06120, Germany; Recruiting
Harald Fritz, MD, Phone: +49 345 5591255, Email: harald.fritz@martha-maria.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; Withdrawn

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; Terminated

Klinikum Hildesheim GmbH, Klinik fuer Kardiologie, Angiologie, Intensivmedizin, Hildesheim 31134, Germany; Withdrawn

Universitätsklinikum des Saarlandes, Homburg/Saar 66421, Germany; Withdrawn

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

Universitaetsklinikum Schleswig Holstein Campus Kiel, Klinik für Anaesthesiologie und Operative Intensivmedizin, Kiel 24105, Germany; Recruiting
Norbert Weiler, MD, Phone: +49 431 5972991, Email: norbert.weiler@uksh.de

Klinikum der Universitaet zu Koeln, Medizinische Klinik I: Innere Medizin, Koeln 50294, Germany; Withdrawn

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 und Poliklinik für Anaesthesiologie und Intensivtherapie, Leipzig 04103, Germany; Recruiting
Sven Bercker, MD, Phone: +49 341 9717704, Email: sven.bercker@uniklinik-leipzig.de

Universitaetsklinikum Mannheim, I. Medizinische Klinik: Kardiologie, Angiologie, Pneumologie, Mannheim 68167, Germany; Withdrawn

Universitaetsklinikum Mannheim, Klinik für Anaesthesiologie und operative Intensivmedizin, Mannheim 68167, Germany; Withdrawn

Universitaetsklinikum Giessen und Marburg GmbH, Standort Marburg, Klinik für Innere Medizin, Schwerpunkt Pneumologie, Marburg 35043, Germany; Withdrawn

Klinikum Nuernberg-Nord, Klinik für Anaesthesiologie und operative Intensivmedizin, Nuernberg 90419, Germany; Withdrawn

Klinikum Oldenburg GmbH, Klinik fuer Anaesthesiologie, Intensivmedizin, Notfallmedizin und Schmerztherapie, Oldenburg 26133, Germany; Recruiting
Andreas Weyland, MD, Phone: +49 441 4032571, Email: weyland.andreas@klinikum-oldenburg.de

Klinikum Ernst von Bergmann GmbH, Klinik für Anaesthesie und Intensivtherapie, Potsdam 14467, Germany; Withdrawn

Rostock Universitaetsklinikum, Klinik und Poliklinik für Anaesthesiologie und Intensivtherapie, Rostock 18057, Germany; Withdrawn

Universitaetsklinikum Ulm, Klinik für Anaesthesiologie, Ulm 89075, Germany; Withdrawn

Additional Information

Competence Network Sepsis (SepNet)

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
Last updated: November 13, 2012

Page last updated: February 07, 2013

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