Status:
COMPLETED
Activated Protein C and Corticosteroids for Human Septic Shock
Lead Sponsor:
University of Versailles
Collaborating Sponsors:
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France
Conditions:
Septic Shock
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 man...
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 c...
Eligibility Criteria
Inclusion
- 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
- 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
- Amendments to eligibility criteria were:
- On 27/03/2008: Changes in following exclusion criteria :
- "surgical procedure in the past 7 days" was changed for "surgical procedure within 72 hours, or any surgery associated with high risk of bleeding, or a planned surgery within 24 h".
- "chronic liver disease" was clarified as "chronic liver disease with Child score C".
- "severe thrombopenia" was clarified "as severe thrombopenia (\<30,000/mm3, before transfusion).
- On 25/08/2009: The exclusion criteria: surgical procedure within 72 hours, or any surgery associated with high risk of bleeding, or a planned surgery within 24 h" was changed for "surgical procedure within 12 hours, or any surgery associated with high risk of bleeding
- On 11/06/2010: the inclusion criteria: admitted to the ICU for \< 7 days was removed; and a new exclusion criteria was added: "patients who had a previous episode of sepsis during the same hospital stay
- On 18/04/2012: following the withdrawal of DAA from the market: the following exclusion criteria (only related to DAA) were removed :
- any surgery in the past 12 hours, or any surgery associated with high risk of bleeding;
- chronic liver disease with a Child score C;
- recent trauma;
- any intracranial mass, or stroke or head injury in the past 3 months;
- severe thrombocytopenia (\< 30.000 /mm3, before platelet transfusion);
- formal indication for anticoagulation, or any other condition associated with increased risk of bleeding, as appreciated by the patient's physician.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
1241 Patients enrolled
Trial Details
Trial ID
NCT00625209
Start Date
March 1 2008
End Date
July 1 2016
Last Update
June 14 2017
Active Locations (4)
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1
Henri Mondor Hospital
Créteil, France, 94
2
Raymond Poincaré Hospital
Garches, France, 92380
3
Pitié Salpêtrière Hospital
Paris, France, 75
4
Saint Josef Hospital
Paris, France, 75