Hydrocortisone for Prevention of Septic Shock (HYPRESS)
This study is currently recruiting participants.
Verified November 2012 by Charite University, Berlin, Germany
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 (Responsible Party):
Didier Keh, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00670254
First received: April 29, 2008
Last updated: November 13, 2012
Last verified: November 2012
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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:
Drug Information available for:
Hydrocortisone acetate
Hydrocortisone
Hydrocortisone sodium succinate
Hydrocortisone cypionate
Hydrocortisone butyrate
Hydrocortisone valerate
Hydrocortisone probutate
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 Anaesthesie, 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 Anaesthesiologie, 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: Sibylle Rademacher, MD +49 30 450 665516 sibylle.rademacher@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, Institut fue Anaesthesie, Schwerpunkt operative Intensivmedizin und SchmerztherapieAnaesthesie, 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 Innere Medizin, Kardiologie und konservative Intensivmedizin | Terminated |
| Berlin, Germany, 12351 | |
| Vivantes Humboldt-Klinikum, Klinik für Innere Medizin - Kardiologie und konservative Intensivmedizin | Recruiting |
| Berlin, Germany, 13509 | |
| Contact: Josefa Lehmke, MD +49 30 130121011 josefa.lehmke@vivantes.de | |
| Vivantes Humboldt Klinikum, Klink fuer Anaesthesie, opertaive Intensivmedizin und Schmerztherapie | Withdrawn |
| 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 | |
| Vivantes Auguste-Viktoria-Klinikum, Klinik fuer Anaesthesiologie, Intensivmedizin und Schmerztherapie | Terminated |
| Berlin, Germany, 12157 | |
| Helios Klinikum Berlin Buch, Klinik für Intensivmedizin | Recruiting |
| Berlin, Germany, 13125 | |
| Contact: Kerstin Resener, MD +49 30 940113105 kerstin.resener@helios-kliniken.de | |
| Rheinische Friedrich-Wilhelms-Universitaet, Klinik für Anaesthesiologie und Operative Intensivmedizin | Terminated |
| Bonn, Germany, 53105 | |
| Krankenhaus Dresden-Friedrichstadt, Klinik für Anaesthesiologie und Intensivmedizin | Recruiting |
| Dresden, Germany, 01067 | |
| Contact: Andreas Nowak, MD +49 351 4801170 nowak-an@khdf.de | |
| 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 | Terminated |
| Freiburg, Germany, 79106 | |
| Ernst Moritz Arndt Universitaet Greifswald, Klinik und Poliklinik für Anaesthesiologie und Intensivmedizin | Recruiting |
| Greifswald, Germany, 17475 | |
| Contact: Matthias Gruendling, MD +49 383 4865810 gruendli@uni-greifswald.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@uk-halle.de | |
| Krankenhaus Martha-Maria Halle-Doelau GmbH | Recruiting |
| Halle (Saale), Germany, 06120 | |
| Contact: Harald Fritz, MD +49 345 5591255 harald.fritz@martha-maria.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 | |
| Klinikum Hildesheim GmbH, Klinik fuer Kardiologie, Angiologie, Intensivmedizin | Withdrawn |
| Hildesheim, Germany, 31134 | |
| 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 | |
| Universitaetsklinikum Schleswig Holstein Campus Kiel, Klinik für Anaesthesiologie und Operative Intensivmedizin | Recruiting |
| Kiel, Germany, 24105 | |
| Contact: Norbert Weiler, MD +49 431 5972991 norbert.weiler@uksh.de | |
| Klinikum der Universitaet zu Koeln, Medizinische Klinik I: Innere Medizin | Withdrawn |
| Koeln, Germany, 50294 | |
| 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 | |
| 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 und Poliklinik für Anaesthesiologie und Intensivtherapie | 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 Oldenburg GmbH, Klinik fuer Anaesthesiologie, Intensivmedizin, Notfallmedizin und Schmerztherapie | Recruiting |
| Oldenburg, Germany, 26133 | |
| Contact: Andreas Weyland, MD +49 441 4032571 weyland.andreas@klinikum-oldenburg.de | |
| 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:
Publications:
| Responsible Party: | Didier Keh, MD, Charite University, Berlin, Germany |
| 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: | November 13, 2012 |
| 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 17-butyrate 21-propionate Hydrocortisone Hydrocortisone-17-butyrate Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Dermatologic Agents |
ClinicalTrials.gov processed this record on May 23, 2013