Corticosteroid Therapy of Septic Shock - Corticus
Corticus
2 other identifiers
interventional
500
9 countries
57
Brief Summary
The purpose of the study is to determine whether steroids decrease 28-day mortality in patients with septic shock.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2002
Typical duration for phase_3
57 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 6, 2005
CompletedFirst Posted
Study publicly available on registry
September 7, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2005
CompletedApril 24, 2008
April 1, 2008
3.7 years
September 6, 2005
April 23, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
28 day mortality in all the non-responders to ACTH (< or = 9 mcg/dl or 250 nmol/L post ACTH)
28 days
Secondary Outcomes (6)
28 day all cause mortality in the total group.
28 days
28 day all cause mortality in responders.
28 days
One year mortality in nonresponders, total and responders.
one year
ICU and hospital mortality.
one year
Organ system failure reversal, especially shock.
one year
- +1 more secondary outcomes
Study Arms (2)
1
EXPERIMENTALhydrocortisone sodium succinate
2
PLACEBO COMPARATORPlacebo
Interventions
50 mg intravenous bolus every six hours for 5 days, then tapered to 50 mg intravenously every 12 hours for days 6-8, 50 mg every 24 hours for days 9-11 and then stopped
Eligibility Criteria
You may qualify if:
- Clinical evidence of infection within the previous 72 hours (may be present longer than 72 hours) (a, b, c, or d - only 1 required)
- Presence of polymorphonuclear cells in a normally sterile body fluid (excluding blood);
- Culture or Gram stain of blood, sputum, urine or normally sterile body fluid positive for a pathogenic micro-organism;
- 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);
- Other clinical evidence of infection - treated community acquired pneumonia, purpura fulminans, necrotising fascitis, etc.
- 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.
- Fever (temperature \>38.3°C) or hypothermia (rectal temperature \< 35.6°C);
- Tachycardia (heart rate of \>90 beat/min);
- Tachypnea (respiratory rate \> 20 breaths/min, PaC02\<32 mmHg) or patient requires invasive mechanical ventilation;
- Alteration of the WBC count \>12,000 cells/mm3, \<4,000 cells/mm3 or \>10% immature neutrophils (bands).
- 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:
- Sustained oliguria (urine output \< 0.5 ml/kg/hr for a minimum of 1 hour)
- Metabolic acidosis \[pH of \< 7.3, or a base deficit of \> or = 5.0 mmol/L, or an increased lactic acid concentration (\> 2 mmol/L)\].
- +5 more criteria
You may not qualify if:
- Pregnancy
- Age less than 18.
- Underlying disease with a prognosis for survival of less than 3 months.
- Cardiopulmonary resuscitation within 72 hours before study.
- Drug-induced immunosuppression, including chemotherapy or radiation therapy within 4 weeks before the study.
- HIV positivity.
- Presence of an advanced directive to withhold or withdraw life sustaining treatment (i.e. DNR).
- Advanced cancer with a life expectancy less than 3 months.
- Acute myocardial infarction or pulmonary embolus.
- Another experimental drug study within the last 30 days.
- Moribund patients likely to die within 24 hours.
- Patients in the ICU for more than 2 months at the time of the start of septic shock.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hadassah Medical Organizationlead
- European Society of Intensive Care Medicinecollaborator
- International Sepsis Forumcollaborator
- The Gorham Foundationcollaborator
Study Sites (57)
LKH Feldkirch
Feldkirch, A-6800, Austria
KH-BHS Linz
Linz, A-4010, Austria
Krankenhaus der Barmherzigen Schwestern Ges. mbH
Linz, A-4010, Austria
Universitaetsklinik fuer Innere Medizin II
Vienna, A 1090, Austria
Hopital St. Joseph
Arlon, B-6700, Belgium
University Hospital Erasme
Brussels, B-1070, Belgium
Cliniques Universitaires St. Luc, UCL
Brussels, B-1200, Belgium
CHU Charleroi
Charleroi, B-6000, Belgium
Hopital Raymond Poincare
Paris, Garches, F-92380, France
Hopital Lariboisiere
Paris, Oarus, F-75010, France
Hopital de Caen
Caen, 14033, France
Hopital Huriez
Lille, F-59037, France
Hopital Caremeau
Nîmes, 30029 cedex 9, France
Hopital Saint-Antoine
Paris, F-75571, France
Zentralklinikum Augsburg
Augsburg, D-86155, Germany
Vivantes-Klinikum im Friedrichshain
Berlin, D - 10249, Germany
Vivantes-Klinikum Spandau
Berlin, D - 13585, Germany
Evangelisches Waldkrankenhaus Spandau
Berlin, D - 13589, Germany
Charité Campus Mitte
Berlin, D-10117, Germany
St. Joseph Krankenhaus
Berlin, D-12101, Germany
Charité - Campus Benjamin Franklin
Berlin, D-12200, Germany
Vivantes-Klinikum Neukoelln
Berlin, D-12313, Germany
Charité - Campus Charité Mitte
Berlin, D-13353, Germany
Charité Campus Virchow -Klinikum
Berlin, D-13353, Germany
Charité Campus Virchow-Klinikum
Berlin, D-13353, Germany
Charité- Campus Virchow- Klinikum
Berlin, D-13353, Germany
Institute for Anaesthesia and Operative Intensive Care
Darmstadt, D-64283, Germany
University Hospital Dresden
Dresden, D- 01307, Germany
Krankenhaus Hennigsdort
Hennigsdorf, D-16761, Germany
Friedrich-Schiller Universitaet
Jena, D - 07740, Germany
Klinikum Kemptern-Oberallegaeu
Kempten, D-87439, Germany
Klinikum Landshut
Landshut, D-84034, Germany
Klinikum Mannheim, University of Heidelberg
Mannheim, D- 68167, Germany
Klinikum Grosshadern, LMU Munich
Munich, D-81377, Germany
Staedtisches Krankenhaus Muenchen-Harlaching
München, D- 81545, Germany
Ludwig-Maximilian-Universitaet Muenchen
München, D-81366, Germany
Univesitaet Erlangen-Namberg
Nuremberg, D-90471, Germany
Klinikum Ernst von Bergman
Potsdam, D-14467, Germany
Haemek Hospital
Afula, 18101, Israel
Hadassah Medical Organisation
Jerusalem, 91120, Israel
Beilinson Medical Centre
Petah Tikva, 491000, Israel
Ichilov Hospital
Tel Aviv, 64239, Israel
Policlinico di Tor Vergata
Roma, 00133, Italy
Centro di Rianimazione Ospedale S.Eugenio
Roma, 00144, Italy
Renier de Graaf Hospital
Delft, 2600 GA, Netherlands
Erasmus University Medical Centre
Rotterdam, 3000 CA, Netherlands
Hospital de St. Antonio do Capuchos
Lisbon, 1150, Portugal
UCIP, Hospital de Desterro
Lisbon, 1150, Portugal
Hospital de Egas Moniz
Lisbon, 1349-019, Portugal
Aberdeen Royal Infirmary
Aberdeen, AB25 2ZD, United Kingdom
Southend Hospital
Essex, SSO ORY, United Kingdom
Ipswich Hospital
Ipswich, IP4 5PD, United Kingdom
Royal Lancaster Infirmary
Lancaster, LA1 4RP, United Kingdom
The General Infirmary at Leeds
Leeds, LS1 3EX, United Kingdom
Bloomsbury Institute of Intensive Care Medicine
London, W1T 3AA, United Kingdom
University of Manchester, Hope Hospital
Salford, M6 8HD, United Kingdom
Southampton General Hospital
Southampton, United Kingdom
Related Publications (3)
Annane D, Briegel J, Sprung CL. Corticosteroid insufficiency in acutely ill patients. N Engl J Med. 2003 May 22;348(21):2157-9. doi: 10.1056/NEJM200305223482123. No abstract available.
PMID: 12761380BACKGROUNDSprung 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.
PMID: 18184957RESULTPolito A, Sonneville R, Guidoux C, Barrett L, Viltart O, Mattot V, Siami S, Lorin de la Grandmaison G, Chretien F, Singer M, Gray F, Annane D, Brouland JP, Sharshar T. Changes in CRH and ACTH synthesis during experimental and human septic shock. PLoS One. 2011;6(11):e25905. doi: 10.1371/journal.pone.0025905. Epub 2011 Nov 3.
PMID: 22073145DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Charles L Sprung, MD
Hadasah Medical Organization
- STUDY DIRECTOR
Djillali Annane, MD
Hopital Raymond Poincare
- STUDY DIRECTOR
Josef Briegel, MD
Ludwig-Maximilian-Universitaet Muenchen
- STUDY DIRECTOR
Didier Keh, MD
Charite Campus Virchow-Klinikum
- STUDY DIRECTOR
Rui Moreno, MD
Hospital de St. António dos Capuchos
- STUDY DIRECTOR
Didier Pittet, MD
University Hospital, Geneva
- STUDY DIRECTOR
Mervyn Singer, MD
University College, London
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 6, 2005
First Posted
September 7, 2005
Study Start
March 1, 2002
Primary Completion
November 1, 2005
Study Completion
November 1, 2005
Last Updated
April 24, 2008
Record last verified: 2008-04