Activated Protein C and Corticosteroids for Human Septic Shock
Information source: University of Versailles
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Septic Shock
Intervention: placebos (Drug); hydrocortisone and fludrocortisone and placebo (Drug); recombinant human activated protein C and placebos (Drug); recombinant human activated protein C and hydrocortisone and fludrocortisone (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: University of Versailles Official(s) and/or principal investigator(s):
Benoit Misset, MD, Principal Investigator, Affiliation: St. Joseph Hospital
Claude Martin, MD, Principal Investigator, Affiliation: Assistance Publique Hopitaux de Marseille, hôpital Nord
Alain Cariou, MD, Principal Investigator, Affiliation: Assistance Publique Hôpitaux de Paris, Hôpital Cochin
Jean Carlet, MD, Principal Investigator, Affiliation: St. Joseph Hospital
Christian Brun Buisson, MD, Principal Investigator, Affiliation: Assistance Publique Hôpitaux de Paris, Hôpital Henri Mondor
Djillali Annane, MD, Principal Investigator, Affiliation: Assistance Publique Hôpitaux de Paris, Hôpital Raymond Poincaré
Overall contact:
Djillali Annane, MD, Phone: 33147107786, Email: djillali.annane@rpc.aphp.fr
Summary
This study aims at comparing the efficacy and safety of recombinant human activated protein C
to that of low dose of corticosteroids and at investigating the interaction between these
drugs in the management of septic shock
Clinical Details
Official title: Phase III of Recombinant Human Activated Protein C and Low Dose of Hydrocortisone and Fludrocortisone in Adult Septic Shock
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Safety/Efficacy Study
Primary outcome: 90-day mortality
Secondary outcome: mortality at 28 daymortality at hospital discharge mortality at 6 months decision to withhold or withdraw active treatments Time to wean vasopressor therapy time to achieve an SOFA score of less than 6 Length of intensive care unit and hospital stay acquisition of new infection bleeding events neurological sequels at intensive care unit discharge and at 90 and 180 days
Detailed description:
Septic shock still places a burden in the healthcare system round around the world. In the
early 20ties, clinical trials suggested potential benefits from activated protein C in severe
sepsis and of corticosteroids when given to adults with refractory shock. More recent studies
suggested that patients with moderate sepsis or septic shock may not benefit from either
activated protein C or corticosteroids. Therefore, current international guidelines suggest
that physicians may consider using these drugs in the more severe cases of sepsis. The main
risk associated with the use of activated protein C is bleeding and the main risk associated
with the use of steroids is superinfection. It is paramount that a new adequately powered
trial explores the benefit/risk ratio of these two drugs and of their combination in a
population of adult patients with septic shock.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- hospitalized in intensive care unit for less than 7 days
- septic shock for less than 24 hours
- at least one proven site of infection
- at least 2 organ dysfunction as defined by a SOFA score =or> to 3 for at least 6
consecutive hours
- need for vasopressor (dopamine =or>15µg/kg/min or epinephrine/norepinephrine at
=or>0,25 µg/kg/min for at least 6 consecutive hours, to maintain systolic arterial
pressure at 90 mmHg or more OR mean arterial pressure at 6( mmHg or more
- informed consent
Exclusion Criteria:
- pregnancy or breath feeding
- decision not to resuscitate
- underlying disease with an estimated life expectancy of less than 1 month
- formal indication for corticosteroids
- recent surgery (ie within the past 72 hours) or a surgery at high risk of bleeding
- gastro-intestinal bleeding within the past 6 weeks
- chronic liver disease (Child C)
- recent trauma (ie within the past 72 hours)
- intracranial process
- history of stroke, CNS bleeding or traumatic brain injury within the past 3 months
- platelet counts of less than 30000 per cubic millimeter
- formal indication for curative anticoagulant; prophylactic use of heparin is allowed
- any condition of high risk of bleeding as per patient's primary physicians
- hypersensitivity of activated drotrecogin alpha or any other component of the drug
- no affiliation to a social security
Locations and Contacts
Djillali Annane, MD, Phone: 33147107786, Email: djillali.annane@rpc.aphp.fr
Raymond Poincaré Hospital, Garches 92380, France; Recruiting
Djillali Annane, MD
Djillali Annane, Principal Investigator
Henri Mondor Hospital, Créteil 94, France; Recruiting
Christian Brun Buisson
Christian Brun Buisson, Principal Investigator
Pitié Salpêtrière Hospital, Paris 75, France; Recruiting
Jean Chastre
Jean Chastre, Principal Investigator
Saint Josef Hospital, Paris 75, France; Recruiting
Benoit Misset
Benoit Misset, Principal Investigator
Additional Information
Starting date: March 2008
Ending date: March 2011
Last updated: April 28, 2008
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