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Corticosteroid Therapy of Septic Shock - Corticus - Article


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Clinical Trial: Corticosteroid Therapy of Septic Shock - Corticus

Corticosteroid Therapy of Septic Shock – Corticus

This study is currently recruiting patients.
Verified by Hadassah Medical Organization August 2005

Sponsors and Collaborators: Hadassah Medical Organization
European Society of Intensive Care Medicine
International Sepsis Forum
The Gorham Foundation
Information provided by: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00147004

Purpose

The purpose of the study is to determine whether steroids decrease 28-day mortality in patients with septic shock
Condition Intervention Phase
Shock, Septic
  Drug: hydrocortisone sodium succinate
 Phase III

MedlinePlus related topics:  Sepsis

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title: Corticosteroid Therapy of Septic Shock – Corticus. A Multi-National, Prospective, Double-Blind, Randomized, Placebo-Controlled Study

Further Study Details: 
Primary Outcomes: 28 day mortality in all the non-responders to ACTH (< or = 9 mcg/dl or 250 nmol/L post ACTH)
Secondary Outcomes: 28 day all cause mortality in the total group.; 28 day all cause mortality in responders.; One year mortality in nonresponders, total and responders.; ICU and hospital mortality.; Organ system failure reversal, especially shock.; Duration of ICU and total hospitalisation.
Expected Total Enrollment:  800

Study start: March 2002

The use of steroids in septic shock remains controversial. The purpose of this study is to determine whether hydrocortisone decreases 28-day mortality in patients with septic shock. The primary end point will be 28-day mortality in all the non-responders to ACTH (< or = 9 mcg/dl or 250 nmol/L post ACTH). Secondary endpoints will be 28 day all cause mortality in the total group and in responders, ICU and hospital mortality, one year mortality, organ system failure reversal especially shock, and duration of ICU and total hospitalisation.

In a double-blinded fashion (randomized on a 1:1 basis), patients receive 50 mg intravenously every 6 hours for 5 days. After 5 days, treatment will be tapered with 50 mg given intravenously every 12 hours for days 6-8, then 50 mg every 24 hours for days 9-11, and then stopped.

All concomitant treatments, including antibiotics, fluids, vasopressors and ancillary therapies will be given at the discretion of the primary care physician. Evidence-based guidelines for the management of severe sepsis and septic shock by the International Sepsis Forum (Intensive Care Med 2001;27:S124-S134) are encouraged to be followed.

All serious adverse events (SAE) which occur between days 0 and 28, which are unexpected and/or considered possibly or probably related to the study medication, must be documented and reported within 24 hours to the Safety and Efficacy Monitoring Committee. Non-serious adverse events will be listed on the case report form if they are unexpected and believed to be related to the study drug during days 0 to 14.

Specific adverse events which will be monitored closely because of their relationship to corticosteroids and shock are:

  1. Use of corticosteroids, i.e. gastrointestinal bleeding and superinfection; hyperglycemia, hypernatremia, muscular weakness, etc.
  2. Shock and use of vasopressors, i.e. stroke, acute myocardial infarction and peripheral ischemia.

In addition, substudies will include harmonization of cortisol by comparing cortisol levels measured in local laboratories and a central laboratory, immune and neuro-endocrine interactions, neuromuscular weakness and cytokines.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

  1. Clinical evidence of infection within the previous 72 hours (may be present longer than 72 hours) (a, b, c, or d – only 1 required)

    1. Presence of polymorphonuclear cells in a normally sterile body fluid (excluding blood);
    2. Culture or Gram stain of blood, sputum, urine or normally sterile body fluid positive for a pathogenic micro-organism;
    3. Focus of infection identified by visual inspection (e.g. ruptured bowel with the presence of free air or bowel contents in the abdomen found at the time of surgery, wound with purulent drainage);
    4. Other clinical evidence of infection – treated community acquired pneumonia, purpura fulminans, necrotising fascitis, etc.

  2. Evidence of a systemic response to infection as defined by the presence of two or more of the following signs within the previous 24 hours. These signs may be present longer than 72 hours.

    1. Fever (temperature >38.3°C) or hypothermia (rectal temperature < 35.6°C);
    2. Tachycardia (heart rate of >90 beat/min);
    3. Tachypnea (respiratory rate > 20 breaths/min, PaC02<32 mmHg) or patient requires invasive mechanical ventilation;
    4. Alteration of the WBC count >12,000 cells/mm3, <4,000 cells/mm3 or >10% immature neutrophils (bands).
  3. Evidence of shock defined by (A + B- both required within the previous 72 hours (may NOT be present longer than 72 hours).

A. A systolic blood pressure < 90 mmHg or a decrease in SBP of more than 50 mmHg from baseline in previous hypertensive patients (for at least one hour) despite adequate fluid replacement OR need for vasopressors for at least one hour (infusion of dopamine ≥ 5 mcg/kg/min or any dose of adrenaline, noradrenaline, phenylephrine or vasopressin) to maintain a SBP ≥ 90 mmHg;

B. Hypoperfusion or organ dysfunction which is not the result of underlying diseases or drugs, but is attributable to sepsis, including one of the following:

  1. Sustained oliguria (urine output < 0.5 ml/kg/hr for a minimum of 1 hour)
  2. Metabolic acidosis [pH of < 7.3, or a base deficit of > or = 5.0 mmol/L, or an increased lactic acid concentration (> 2 mmol/L)].
  3. Arterial hypoxemia (Pa02/FI02<280 in the absence of pneumonia)(Pa02/FI02<200 in the presence of pneumonia).
  4. Thrombocytopenia – platelet count ≤ 100,000 cells/mm3.
  5. Acute altered mental status (Glasgow Coma Scale < 14 or acute change from baseline).

4. Informed Consent

5. Cortisol level at baseline and 60 minutes after 0.25 mg cosyntropin

Exclusion Criteria:

  1. Pregnancy
  2. Age less than 18.
  3. Underlying disease with a prognosis for survival of less than 3 months.
  4. Cardiopulmonary resuscitation within 72 hours before study.
  5. Drug-induced immunosuppression, including chemotherapy or radiation therapy within 4 weeks before the study.
  6. Administration of chronic corticosteroids in the last 6 months or acute steroid therapy (any dose) within 4 weeks (including inhaled steroids). Topical steroids are not exclusions.
  7. HIV positivity.
  8. Presence of an advanced directive to withhold or withdraw life sustaining treatment (i.e. DNR).
  9. Advanced cancer with a life expectancy less than 3 months.
  10. Acute myocardial infarction or pulmonary embolus.
  11. Another experimental drug study within the last 30 days.
  12. Moribund patients likely to die within 24 hours.
  13. Patients in the ICU for more than 2 months at the time of the start of septic shock.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00147004

Charles L Sprung, MD      972 2 677 8060    sprung@cc.huji.ac.il

Austria
      Universitaetsklinik fuer Innere Medizin II, Wien,  A 1090,  Austria; Recruiting
Gottfried Heinz, MD  43 1 40400 4644    gottfried.Heinz@univie.ac.at 
Gottfried Heinz, MD,  Principal Investigator

      LKH Feldkirch, Feldkirch,  A-6800,  Austria; Recruiting
Peter Fae, MD  43 55 222 303 9150    pfae@vol.at 
Peter Fae, MD,  Principal Investigator

      Krankenhaus der Barmherzigen Schwestern Ges. mbH, Linz,  A-4010,  Austria; Recruiting
Wolfgang Sieber, MD  43 732 7677 4893    wolfgang.sieber@bhs.at 
Wolfgang Sieber, MD,  Principal Investigator

      KH-BHS Linz, Linz,  A-4010,  Austria; Recruiting
Johann Reisinger, MD   johann.reisinger@bhs.at 
Johann Reisinger, MD,  Principal Investigator

Belgium
      Cliniques Universitaires St. Luc, UCL, Brussels,  B-1200,  Belgium; Recruiting
Pierre-Francois Laterre, MD  32 2 764 2735    laterre@rean.ucl.ac.be 
Pierre-Francois Laterre, MD,  Principal Investigator
Xavier Wittebole, MD,  Sub-Investigator

      University Hospital Erasme, Brussels,  B-1070,  Belgium; Recruiting
Jean-Louis Vincent, MD  32 2 555 3380    jlvincen@ulb.ac.be 
Jean-Louis Vincent, MD,  Principal Investigator
Daniel De Backer, MD,  Sub-Investigator

      Hopital St. Joseph, Arlon,  B-6700,  Belgium; Recruiting
Marc Simon, MD  32 63 23 16 81    rea.arlon@clinsudlux.be 
Marc Simon, MD,  Principal Investigator

      CHU Charleroi, Charleroi,  B-6000,  Belgium; Recruiting
Patick Biston, MD  32 71 921355    patrick.biston@chu-charleroi.be 
Patrick Biston, MD,  Principal Investigator

France
      Hopital Saint-Antoine, Paris,  F-75571,  France; Recruiting
Georges Offenstadt, MD  33 1 4928 2315    georges.offenstadt@sat.ap-hop-paris.fr 
Georges Offenstadt, MD,  Principal Investigator
Jerome Lemant, MD,  Sub-Investigator

      Hopital Huriez, Lille,  F-59037,  France; Recruiting
Benoit Vallet, MD  33 3 2044 6219    bvallet@chru-lille.fr 
Benoit Vallet, MD,  Principal Investigator

      Hopital de Caen, Caen,  14033,  France; Recruiting
Cedric Daubin, MD  33 2 31 06 47 05    daubin-d@chu-caen.fr 
Cedric Daubin, MD,  Principal Investigator

      Hopital Caremeau, Nimes,  30029 cedex 9,  France; Recruiting
Jean Y Lefrant, MD  33 4 66 68 33 17    jean.yves.lefrant@chu-nimes.fr 
Jean Y Lefrant, MD,  Principal Investigator

France, Garches
      Hopital Raymond Poincare, Paris,  Garches,  F-92380,  France; Recruiting
Djillali Annane, MD  33 1 4710 7780    djillali.annane@rpc.ap-hop-paris.fr 
Djillali Annane, MD,  Principal Investigator

France, Oarus
      Hopital Lariboisiere, Paris,  Oarus,  F-75010,  France; Recruiting
Didier Payen, MD  33 1 4995 8085    dpayen1234@aol.com 
Didier Payen, MD,  Principal Investigator

Germany
      Ludwig-Maximilian-Universitaet Muenchen, Muenchen,  D-81366,  Germany; Recruiting
Josef Briegel, MD  49 89 7095 2927    jbriegel@ana.med.uni-muenchen.de 
Josef Briegel, MD,  Principal Investigator

      Zentralklinikum Augsburg, Augsburg,  D-86155,  Germany; Recruiting
Helmut Forst, MD  49 821 400 2370    forst@anaesthesie-klinikum-augsburg.de 
Helmut Forst, MD,  Principal Investigator
Gertraud Neeser, MD,  Sub-Investigator

      Charité Campus Virchow -Klinikum, Berlin,  D-13353,  Germany; Recruiting
Didier Keh, MD  39 30 4505 1001    didier.keh@charite.de 
Didier Keh, MD,  Principal Investigator

      Charité- Campus Virchow- Klinikum, Berlin,  D-13353,  Germany; Recruiting
Jan Langrehr, MD  49 30 4505 2233    jan.langrehr@charite.de 
Jan Langrehr, MD,  Principal Investigator

      Klinikum Ernst von Bergman, Potsdam,  D-14467,  Germany; Recruiting
Dirk Pappert, MD  49 331 241 5001    dirk.pappert@charite.de 
Dirk Pappert, MD,  Principal Investigator

      Charité Campus Mitte, Berlin,  D-10117,  Germany; Recruiting
Claudia Spies, MD  49 30 4505 31031    claudia.spies@charite.de 
Claudia Spies, MD,  Principal Investigator
K. Haubold, MD,  Sub-Investigator

      Charité Campus Virchow-Klinikum, Berlin,  D-13353,  Germany; Recruiting
Michael Oppert, MD  49 30 4505 53654    michael.oppert@charite.de 
Michael Oppert, MD,  Principal Investigator

      Vivantes-Klinikum im Friedrichshain, Berlin,  D - 10249,  Germany; Recruiting
Siegfried Veit, MD  49 30 4221 1570    s.veit@khf.de 
Siegfried Veit, MD,  Principal Investigator

      Vivantes-Klinikum Spandau, Berlin,  D – 13585,  Germany; Recruiting
Klaus J Slama, MD  49 30 3387 2101    klausjuergen.slama@vivantes.de 
Klaus-Juergen Slama, MD,  Principal Investigator

      Evangelisches Waldkrankenhaus Spandau, Berlin,  D - 13589,  Germany; Recruiting
Mathias Reyle-Hahn, MD  49 30 3702 1821    reylehahn@web.de 
Mathias Reyle-Hahn, MD,  Principal Investigator

      Friedrich-Schiller Universitaet, Jena,  D – 07740,  Germany; Recruiting
Konrad Reinhart, MD  49 3641 9323 101    konrad.reinhart@med.uni-jena.de 
Konrad Reinhart, MD,  Principal Investigator
Frank Brunkhorst, MD,  Sub-Investigator

      Klinikum Kemptern-Oberallegaeu, Kempten,  D-87439,  Germany; Recruiting
Mathias Haller, MD  49 381 530 3362    mathias.haller@klinikum-kempten.de 
Mathias Haller, MD,  Principal Investigator

      Staedtisches Krankenhaus Muenchen-Harlaching, Muenchen,  D- 81545,  Germany; Recruiting
Maximillian Klimmer, MD  49 84 6210 362366    anaesthesie.klimmer@khmh.de 
Maximilian Klimmer, MD,  Principal Investigator

      Vivantes-Klinikum Neukoelln, Berlin,  D-12313,  Germany; Recruiting
Herwig Gerlach, MD  49 30 6004 2360    herwig.gerlach@vivantes.de 
Herwig Gerlach, MD,  Principal Investigator

      Charité - Campus Charité Mitte, Berlin,  D-13353,  Germany; Recruiting
Simone Rosseau, MD  49- 30-450-553365    simone.rosseau@charite.de 
Simone Rosseau, MD,  Principal Investigator

      Institute for Anaesthesia and Operative Intensive Care, Darmstadt,  D-64283,  Germany; Recruiting
Martin Welte, MD   martin.welte@klinikum-darmstadt.de 
Martin Welte, MD,  Principal Investigator

      University Hospital Dresden, Dresden,  D- 01307,  Germany; Recruiting
Christian Marx, MD  49 351458 3417    Christian.Marx@uniklinikum-dresden.de 
Christian Marx, MD,  Principal Investigator

      St. Joseph Krankenhaus, Berlin,  D-12101,  Germany; Recruiting
Martin Schmutzler, MD  49-30-7882-2384    Martin.Schmutzler@rz.hu-berlin.de 
Martin Schmutzler, MD,  Principal Investigator

      Klinikum Landshut, Landshut,  D-84034,  Germany; Recruiting
U Helms, MD   anaesthesie@klinikum-landshut.de 
U Helms, MD,  Principal Investigator

      Univesitaet Erlangen-Namberg, Nurenberg,  D-90471,  Germany; Recruiting
Martin Baumgaertel, MD   baumgaertel@klinikum-nuernberg.de 
Martin Baumgaertel, MD,  Principal Investigator

      Klinikum Mannheim, University of Heidelberg, Mannheim,  D- 68167,  Germany; Recruiting
Armin Kalenka, MD  49 621 383 3233    armin.kalenka@urz.uni-hd.de 
Armin Kalenka, MD,  Principal Investigator
Fritz Fiedler, MD,  Sub-Investigator

      Krankenhaus Hennigsdort, Hennigsdorf,  D-16761,  Germany; Recruiting
Andreas Lange, MD  49 (0)3302-545100    Arezzo@t-online.de 
Andreas Lange, MD,  Principal Investigator

      Klinikum Grosshadern, LMU Munich, Munich,  D-81377,  Germany; Recruiting
Wolfgang Hartl, MD  49-89-7095-0    Wolfgang.Hartl@med.uni-muenchen.de 
Wolfgang Hartl, MD,  Principal Investigator

      Charité - Campus Benjamin Franklin, Berlin,  D-12200,  Germany; Recruiting
Joerg Weimann, MD, DEAA  49-30-8445-2731    joerg.weimann@charite.de 
Joerg Weimann, MD, DEAA,  Principal Investigator

Israel
      Hadassah Medical Organisation, Jerusalem,  91120,  Israel; Recruiting
Charles L Sprung, MD  972 2 677 8060    sprung@cc.huji.ac.il 
Yoram Weiss, MD  972 50 787 4050    weiss@hadassah.org.il 
Charles L Sprung, MD,  Sub-Investigator
Yoram Weiss, MD,  Principal Investigator

      Haemek Hospital, Afula,  18101,  Israel; Recruiting
Ami Lev, MD  972 4 652 4179    levamirm@netvision.net.il 
Ami Lev, MD,  Principal Investigator

      Ichilov Hospital, Tel Aviv,  64239,  Israel; Recruiting
Patrick Sorkine, MD  972-3 697 3247    sorkine@tasmc.health.gov.il 
Patrick Sorkine, MD,  Principal Investigator
Adi Nimrod, MD,  Sub-Investigator

      Beilinson Medical Centre, Petach Tikva,  491000,  Israel; Recruiting
Pierre Singer, MD  972 3 937 6521    psinger@clalit.org.il 
Pierre Singer, MD,  Principal Investigator

Italy
      Policlinico di Tor Vergata, Roma,  00133,  Italy; Recruiting
Silvia Natoli, MD  39-6-2090 0754    silvianatoli@yahoo.it 
Silvia Natoli, MD,  Principal Investigator

      Centro di Rianimazione Ospedale S.Eugenio, Roma,  00144,  Italy; Recruiting
Franco Turani, MD  39 34 8472 5073    franco.turani@fastwebnet.it 
Franco Turani, MD,  Principal Investigator

Netherlands
      Erasmus University Medical Centre, Rotterdam,  3000 CA,  Netherlands; Recruiting
Ben van der Hoven, MD  31-10-463 92 22    b.vanderhoven.1@erasmusmc.nl .nl 
Ben van der Hoven, MD,  Principal Investigator

      Renier de Graaf Hospital, Delft,  2600 GA,  Netherlands; Recruiting
E F Salm, MD  31 1 5260 4938    Salm@rdgg.nl 
E F Salm, MD,  Principal Investigator

Portugal
      Hospital de St. Antonio do Capuchos, Lisboa,  1150,  Portugal; Recruiting
Rui Moreno, MD  351 21 315 3784    r.moreno@mail.telepac.pt 
Rui Moreno, MD,  Principal Investigator

      UCIP, Hospital de Desterro, Lisbon,  1150,  Portugal; Recruiting
Eduardo Silva, MD  351 21 885 3783    eduardog.silva@mail.telepac.pt 
Eduardo Silva, MD,  Principal Investigator

      Hospital de Egas Moniz, Lisbon,  1349-019,  Portugal; Recruiting
Pedro Abecasis, MD   ucig@hegasmoniz.min-saude.pt 
Pedro Abecasis, MD,  Principal Investigator

United Kingdom
      Aberdeen Royal Infirmary, Aberdeen,  AB25 2ZD,  United Kingdom; Recruiting
Brian Cuthbertson, MD  44) 1224 552730    b.h.cuthbertson@abdn.ac.uk 
Brian Cuthbertson, MD,  Principal Investigator

      Bloomsbury Institute of Intensive Care Medicine, London,  W1T 3AA,  United Kingdom; Recruiting
Mervyn Singer, MD  44 20 7679 9666    m.singer@ucl.ac.uk 
Mervyn Singer, MD,  Principal Investigator

      The General Infirmary at Leeds, Leeds,  LS1 3EX,  United Kingdom; Recruiting
Abhiram Mallick, MD  44-113-395679    Abhiram.Mallick@leedsth.nhs.uk 
Abhiram Mallick, MD,  Principal Investigator

      Ipswich Hospital, Ipswich,  IP4 5PD,  United Kingdom; Recruiting
Mark Garfield, MD   mark.garfield@doctors.org.uk 
Mark Garfield, MD,  Principal Investigator

      Southampton General Hospital, Southampton,  United Kingdom; Recruiting
Tom Woodcock, MD  44 [0] 23 8079 4216    Tom.Woodcock@suht.swest.nhs.uk 
Tom Woodcock, MD,  Principal Investigator

      Royal Lancaster Infirmary, Lancaster,  LA1 4RP,  United Kingdom; Recruiting
Charles Granger, MD  44-1 5246 5944    Charlie.Granger@t.bay-tr.nwest.nhs.uk 
Charles Granger, MD,  Principal Investigator

      University of Manchester, Hope Hospital, Salford,  M6 8HD,  United Kingdom; Recruiting
Paul M Dark, MD  44 161 206 4718    paul.m.dark@man.ac.uk 
Paul M Dark, MD,  Principal Investigator

      Southend Hospital, Essex,  SSO ORY,  United Kingdom; Recruiting
David Higgins, MD   David.Higgins@southend.nhs.uk 
David Higgins, MD,  Principal Investigator

Study chairs or principal investigators

Charles L Sprung, MD,  Study Chair,  Hadasah Medical Organization   
Djillali Annane, MD,  Study Director,  Hopital Raymond Poincare   
Josef Briegel, MD,  Study Director,  Ludwig-Maximilian-Universitaet Muenchen   
Didier Keh, MD,  Study Director,  Charite Campus Virchow-Klinikum   
Rui Moreno, MD,  Study Director,  Hospital de St. António dos Capuchos   
Didier Pittet, MD,  Study Director,  Geneva University Hospitals   
Mervyn Singer, MD,  Study Director,  University College, London   

More Information

Publications

Annane D, Briegel J, Sprung CL. Corticosteroid insufficiency in acutely ill patients. N Engl J Med. 2003 May 22;348(21):2157-9. No abstract available.

Annane D, Briegel J, Keh D, Moreno R, Singer M, Sprung CL; Corticus Study Coordinators. Clinical equipoise remains for issues of adrenocorticotropic hormone administration, cortisol testing, and therapeutic use of hydrocortisone. Crit Care Med. 2003 Aug;31(8):2250-1; author reply 2252-3. No abstract available.

Study ID Numbers:  QLK2-CT-2000-00589; EC- QLK2-CT-2000-00589
Last Updated:  September 6, 2005
Record first received:  September 6, 2005
ClinicalTrials.gov Identifier:  NCT00147004
Health Authority: Austria: Federal Ministry for Health and Women; Belgium: Directorate general for the protection of Public health: Medicines; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medicinal Devices; Israel: Israeli Health Ministry Pharmaceutical Administration; Italy: National Monitoring Centre for Clinical Trials - Ministry of Health; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Portugal: National Pharmacy and Medicines Institute; Spain: Spanish Agency of Medicines; United Kingdom: Medicines and Healthcare Products Regulatory Agency
ClinicalTrials.gov processed this record on 2005-09-13


Source: ClinicalTrials.gov
Cache Date: September 14, 2005


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