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Severe SepsisPhase 3HYPRESSNCT00670254

Hydrocortisone for Prevention of Septic Shock

A Phase 3 study testing Hydrocortisone in people with Severe Sepsis, run by Charite University, Berlin, Germany at 30 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Severe Sepsis
What is being tested?
Hydrocortisone
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
380 participants
Where
30 sitesGermany
Study dates
Jan 2009to Aug 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Severe sepsis according to ACCP/CCM criteria
  • Onset of severe sepsis < 48 hours
  • Informed consent
  • Effective contraception in fertile women

Who cannot join

  • 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
Show all 11Show fewer
  • Pregnancy
  • Breast feeding women
  • Age < 18 years
  • Other interventional study
  • Relationship to investigator

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

Germany30 sites

  • Universitaetsklinikum Aachen, Operative Intensivmedizin Erwachsene

    Aachen, 52074

  • Zentralklinik Bad Berka GmbH, Zentrum für Anaesthesie, Intensivtherapie und Notfallmedizin

    Bad Berka, 99437

  • HELIOS Klinikum Bad Saarow; Zentrum für Anaesthesiologie, Intensivmedizin, Notfallmedizin und Schmerztherapie

    Bad Saarow, 15526

  • St. Joseph Krankenhaus, Institut fue Anaesthesie, Schwerpunkt operative Intensivmedizin und SchmerztherapieAnaesthesie, operative Intensiv- und Notfallmedizin

    Berlin, 12101

  • Vivantes Auguste-Viktoria-Klinikum, Klinik fuer Anaesthesiologie, Intensivmedizin und Schmerztherapie

    Berlin, 12157

  • Vivantes Klinikum Neukoelln,Klinik fuer Innere Medizin, Kardiologie und konservative Intensivmedizin

    Berlin, 12351

  • Vivantes Klinikum-Neukoelln, Klinik fuer Anaesthesie, operative Intensivmedizin und Schmerztherapie

    Berlin, 12351

  • Vivantes Klinikum Hellersdorf, Klinik fuer Anaesthesie, operative Intensivmedizin und Schmerztherapie

    Berlin, 12621

  • Helios Klinikum Berlin Buch, Klinik für Intensivmedizin

    Berlin, 13125

  • Charité Universitaetsmedizin Berlin, Campus Virchow-Klinikum und Campus Mitte, Med. Klinik mit Schwerpunkt Infektiologie und Pneumologie

    Berlin, 13353

  • Charité Universitaetsmedizin Berlin, Campus Virchow-Klinikum und Mitte Klinik für Anaesthesiologie und operative Intensivmedizin

    Berlin, 13353

  • Charité Universitätsmedizin Berlin, Campus Virchow-Klinikum, Med. Klinik mit Schwerpunkt Nephrologie und internistische Intensivmedizin

    Berlin, 13353

  • Vivantes Humboldt-Klinikum, Klinik für Innere Medizin - Kardiologie und konservative Intensivmedizin

    Berlin, 13509

  • Rheinische Friedrich-Wilhelms-Universitaet, Klinik für Anaesthesiologie und Operative Intensivmedizin

    Bonn, 53105

  • St. Elisabeth-Krankenhaus Köln-Hohenlind, Klinik für Anaesthesiologie und operative Intensivmedizin

    Cologne, 50935

  • Kliniken der Stadt Koeln - Krankenhaus Merheim, Klinik für Anaesthesiologie und operative Intensivmedizin

    Cologne, 51058

  • Krankenhaus Dresden-Friedrichstadt, Klinik für Anaesthesiologie und Intensivmedizin

    Dresden, 01067

  • Universitaetsklinik Carl Gustav Carus Dresden

    Dresden, 01307

  • Helios Klinikum Erfurt, Klinik fuer Anaesthesie, Intensivmedizin und Schmerztherapie

    Erfurt, 99089

  • Universitaetsklinikum Freiburg, Anaesthesiologische Universitaetsklinik - Abteilung Anaesthesiologie und Intensivtherapie

    Freiburg im Breisgau, 79106

  • Ernst Moritz Arndt Universitaet Greifswald, Klinik und Poliklinik für Anaesthesiologie und Intensivmedizin

    Greifswald, 17475

  • Medizinische Fakultaet der Martin-Luther-Universitaet Halle-Wittenberg - Universitaetsklinikum Halle (Saale)

    Halle, 06097

  • Krankenhaus Martha-Maria Halle-Doelau GmbH

    Halle, 06120

  • Universitaetsklinikum Hamburg-Eppendorf, Klinik für Intensivmedizin

    Hamburg, 20246

  • Klinikum Heidenheim, Klinik für Anaesthesiologie und operative Intensivmedizin

    Heidenheim, 89522

  • Klinik Henningsdorf der Oberhavel-Kliniken GmbH, Abteilung für Anaesthesie und Intensivmedizin

    Henningsdorf, 16716

  • Friedrich Schiller Universität, Klinik für Anaesthesiologie und Intensivmedizin

    Jena, 07747

  • Universitaetsklinikum Schleswig Holstein Campus Kiel, Klinik für Anaesthesiologie und Operative Intensivmedizin

    Kiel, 24105

  • Universitaetsklinikum Leipzig AöR, Klinik und Poliklinik für Anaesthesiologie und Intensivtherapie

    Leipzig, 04103

  • Klinikum Oldenburg GmbH, Klinik fuer Anaesthesiologie, Intensivmedizin, Notfallmedizin und Schmerztherapie

    Oldenburg, 26133

Other trials in Germany

About this study

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

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.

Conditions
Severe Sepsis
Being tested
Placebo, Hydrocortisone
Keywords
Sepsis, Septic, Shock, Glucocorticoids, Hydrocortisone
Medical subject headings
Sepsis, Shock

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Application is identical to experimental arm

  • HydrocortisoneDrug

    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.

Study groups in NCT00670254
Study groupRoleWhat they receive
HydrocortisoneExperimentalNot described
Receives: Drug: Hydrocortisone
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Septic shock

    Measured: 14 days

Secondary outcomes (18)

  1. Mortality

    Measured: 28, 90, and 180 days; ICU and hospital

  2. Length of stay

    Measured: ICU and hospital (3-6 months)

  3. Time to death

    Measured: 28, 90, and 180 days

  4. Time to septic shock

    Measured: 14 days

  5. Mechanical ventilation

    Measured: until ICU discharge

  6. Renal replacement therapy

    Measured: until ICU discharge

  7. Organ dysfunction (SOFA score)

    Measured: until ICU discharge but day 14 at maximum

  8. Frequency of weaning failure

    Measured: until ICU discharge

  9. Frequency and severity of muscle weakness

    Measured: until ICU discharge

  10. Frequency of gastrointestinal bleeding

    Measured: 28 days

  11. Frequency of secondary infections

    Measured: 28 days

  12. Delir

    Measured: ICU discharge

  13. Hypernatremia

    Measured: 14 days

  14. Hyperglycemia

    Measured: 14 days

  15. Other adverse events

    Measured: 28 days

  16. Posttraumatic stress disorder / health-related quality of life

    Measured: Hosptal discharge and 180 days after hospital discharge

  17. Immune response to hydrocortisone

    Measured: 6 days

  18. Adrenal function

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2008 (estimated)
  2. Study startJan 2009
  3. Primary completionAug 2013
  4. Study completionAug 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
380 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00670254
Sponsor's protocol ID
HYPRESS
Other IDs
01KG0701, 2007-004401-10
Acronym
HYPRESS
Status last verified
Sep 2013
First submitted
29 Apr 2008
Last updated
27 Sep 2013
Results posted
No
Data monitoring committee
Yes

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. doi: 10.1097/01.CCM.0000298158.12101.41.

    PubMed 18158437

  • Reinhart K, Brunkhorst F, Bone H, Gerlach H, Grundling M, Kreymann G, Kujath P, Marggraf G, Mayer K, Meier-Hellmann A, Peckelsen C, Putensen C, Quintel M, Ragaller M, Rossaint R, Stuber F, Weiler N, Welte T, Werdan K; Deutschen Interdisziplinaren Vereinigung fur 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. doi: 10.1007/s00108-006-1595-x. German.

    PubMed 16532281

  • 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. doi: 10.1007/s00134-006-0517-7. Epub 2007 Feb 24.

    PubMed 17323051

  • 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. doi: 10.1056/NEJMoa071366.

    PubMed 18184957

  • 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. doi: 10.1002/14651858.CD002243.pub2.

    PubMed 14973984

  • 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. doi: 10.1164/rccm.200205-446OC. Epub 2002 Nov 8.

    PubMed 12426230

  • 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.

    PubMed 1597042

  • Briegel J, Mohnle P, Keh D, Lindner JM, Vetter AC, Bogatsch H, Lange D, Frank S, Hinske LC, Annane D, Vogeser M; SepNet Critical Care Trials Group. Corticotropin-stimulated steroid profiles to predict shock development and mortality in sepsis: From the HYPRESS study. Crit Care. 2022 Nov 7;26(1):343. doi: 10.1186/s13054-022-04224-5.

    PubMed 36345013

  • Keh D, Trips E, Marx G, Wirtz SP, Abduljawwad E, Bercker S, Bogatsch H, Briegel J, Engel C, Gerlach H, Goldmann A, Kuhn SO, Huter L, Meier-Hellmann A, Nierhaus A, Kluge S, Lehmke J, Loeffler M, Oppert M, Resener K, Schadler D, Schuerholz T, Simon P, Weiler N, Weyland A, Reinhart K, Brunkhorst FM; SepNet-Critical Care Trials Group. Effect of Hydrocortisone on Development of Shock Among Patients With Severe Sepsis: The HYPRESS Randomized Clinical Trial. JAMA. 2016 Nov 1;316(17):1775-1785. doi: 10.1001/jama.2016.14799.

    PubMed 27695824

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Hydrocortisone in people with Severe Sepsis, run by Charite University, Berlin, Germany at 30 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Septic shock (time frame: 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00670254, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2013.

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