to Determine Efficacy and Safety ofExtended Drotrecogin Alfa (Activated) Therapy inPatients With Persistent Requirement for VasopressorSupport After 96-Hour Infusion With CommercialDrotrecogin Alfa (Activated
- Conditions
- in severe sepsis patients with persistent vasopressordependenthypotensionTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2004-001319-71-ES
- Lead Sponsor
- illy S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 270
[1] Are adult (?18 year old) with severe sepsis that have been treated with
at least 84 hours of a planned 96-hour infusion of commercial
drotrecogin alfa (activated) under the applicable label in the
investigative site country.
[2] Continues to require vasopressor support (epinephrine, phenylephrine,
vasopressin, or norepinephrine) at any dose or dopamine ?5?g/kg/min
at the completion of at least 84 hours of a planned 96-hour infusion of
therapy with commercial drotrecogin alfa (activated).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 135
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 135
[3] Expected to require extensive and/or multiple surgical procedure(s)
(i.e. staging surgery for burn patients) within the next 3 days.
[4] Patients with a platelet count <30,000/mm3.
[5] Are receiving therapeutic heparin, defined as ?15,000 IU per day.
Unfractionated heparin up to 15 U/kg/hr may be used in conjunction
with acute hemodialysis or continuous renal replacement therapy.
[6] Are not expected to survive the 24 day (maximum) Study Treatment
and Post Study Treatment Period given their preexisting uncorrectable
medical condition.
[7] Are moribund and death is perceived to be imminent within 24 hours.
[8] Patients whose family and/or primary physician have not committed to
aggressive management of the patient. For instance patients or
patients? authorized representative is unwilling to allow red blood cell
transfusions or an advanced directive to withhold life-sustaining
treatment, with the exception of cardiopulmonary resuscitation (CPR),
is present.
[9] Have received treatment within the last 30 days with a drug that has
not received regulatory approval for any indication at the time of study
entry.
[10] Are pregnant or are lactating and the milk is to be ingested by the
child.
[11] Are contraindicated for treatment with drotrecogin alfa (activated)
under the applicable label in the investigative site country.
[12] Have no completed written informed consent signed by the patient or
the patient?s legal representative.
[13] No longer dependent upon vasopressors
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method