A Phase III, Multicenter, Randomized, Placebo-Controlled Study of PHP When Administered by Continuous Infusion in Patients With Catecholamine-Resistant Distributive Shock
- Conditions
- A41.9R57Sepsis, unspecifiedShock, not elsewhere classified
- Registration Number
- DRKS00000181
- Lead Sponsor
- Apex Bioscience, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting stopped after recruiting started
- Sex
- All
- Target Recruitment
- 377
SIRS Inclusion Criteria:
- Patients with SIRS as characterized by two or more of the following conditions (worst values in a 24 hour period):
a) Either respiratory rate >= 20 breaths/minute, or partial pressure of arterial carbon dioxide (PaCO2) <= 32 torr, or mechanical ventilation;
b) Heart rate >= 90 beats/minute;
c) Either hyperthermia >= 38 ºC or hypothermia <= 36 ºC;
d) Either white blood cell (WBC) >= 12,000 cells/mm3, <= 4,000 cells/mm3, or >= 10% immature (band) forms.
Shock Inclusion Criteria:
Patients with adequate fluid resuscitation and requiring a norepinephrine dose of >= 0.3 mcg/kg/min for at least one hour to maintain a MAP >= 65 mmHg but <= 80 mmHg within the first 36 hours of the initiation of norepinephrine treatment. If a patient reaches the Norephinephrine dose threshold for enrolment, but begins to improve before randomization, then the patient should only be randomized if the Norepinephrine dose is still >=0,2 mcg/kg/min
- Patients who lack documented Informed Consent signed by the patient or his/her legally authorized representative
- Patients that are pregnant
- Patients less than 18 years old
- Patients with suspicion of or active treatment for coronary artery disease within 60 days of enrollment defined as any of the following: acute myocardial infarction with an abnormal ECG indicative of myocardial infarction or abnormal regional wall motion (echocardiography), unstable angina with abnormal regional wall motion (echocardiography) and/or EF < 35%, coronary revascularization (angioplasty, stenting, coronary bypass graft) if EF < 35%
- Patients who have received a stent within the last 12 months
- Patients with suspicion of or active treatment for malignant arrhythmia within 60 days of enrollment defined as any of the following: ventricular tachycardia, ventricular fibrillation, appropriate defibrillator firing in patient with AICD; Note: A peacemaker is not an exclusion criterion
- Patients with suspicion of or active treatment for congestive heart failure within 60 days of enrollment defined as any of the following: ejection fraction < 35% and LV end-diastolic dimension > 6.0 cm demonstrated by echo or MUGA, or hospitalization primarily for congestive heart failure, or NYHA Class IV congestive heart failure
- Patients with suspicion of or active treatment for aortic valve heart disease within 60 days of enrollment defined as any of the following: aortic valve stenosis with area < 1.0 cm2, or severe aortic insufficiency, or after aortic valve replacement if ejection fraction < 35%
- Patients with stage 3 or 4 solid tumors (TNM classification, group staging), hematologic malignancies with high tumor burden, CNS cancer (WHO stage 3 and 4) unless significant tumor mass was removed near occurrence of shock
- Patients with dead bowel likely to result in death. After surgical removal of the dead bowel the patient can be enrolled
- Patients receiving/scheduled to receive another investigational drug or have received an investigational drug in the previous 30 days
- Patients with known hypersensitivity to blood products
- Patients with hypovolemic shock from bleeding or other volume loss
- Patients who are likely to die within days for diseases or conditions other than catecholamine-dependent shock (e.g. multiple organ failure that is irreversible as distinct from multiple organ dysfunction that may resolve)
- Patients with Glasgow Coma Score <= 7 at the time of admission and prior to the administration of confounding medications such as narcotics, sedatives or neuromuscular blockers
- Patients that experienced trauma within the past 48 hours
- Patients that experienced burns within the past 48 hours
- Patients with anaphylactic shock
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 28 day all-cause mortality
- Secondary Outcome Measures
Name Time Method All-cause mortality at days 3, 7, 14, and 21 || Survival time || Survivor days in the intensive care unit censored at 28 days || Survivors' hospital length of stay censored at 28 days || Time on mechanical ventilation || Time on pressors || All-cause mortality at days 60 and 90