PHP for the Treatment of Excess Nitric Oxide in Distributive Shock (PHOENIX)

• Conditions: Catecholamine-resistant distributive shock; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]; MedDRA version: 14.0Level: PTClassification code 10040070Term: Septic shockSystem Organ Class: 10021881 - Infections and infestations

• Registration Number: EUCTR2008-000504-92-AT
• Lead Sponsor: Apex Bioscience, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-12
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 454

Inclusion Criteria

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°C, or hypothermia = 36°C
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 (see guidelines in Section IV.G.) 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 24 hours of the initiation of norepinephrine treatment.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 270
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 184

Exclusion Criteria

Exclusion Criteria
·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 for 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 pacemaker 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 echocardiography or MUGA
-Hospitalization primarily for congestive heart failure
-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
- Severe aortic insufficiency
- After aortic valve replacement if EF < 35%
(If there is no history of coronary artery disease, malignant arrhythmia, congestive heart failure, or aortic valve heart disease, the patient may be enrolled without further cardiac evaluation. If history is ambiguous, an echocardiogram may be performed to exclude suspected diagnosis (e.g. to assess ejection fraction or aortic valve performance). Patients successfully treated for any of the above conditions earlier than 60 days before enrollment, who are asymptomatic and in stable clinical condition, may be enrolled (e.g. CABG 1 year before with no ongoing angina). This rule is not applied in patients with stents.
Prior to randomization, the cardiac status of the subject, from the perspective of study eligibility, must be documented in the medical or research record, and be supported by the baseline medical history.
·Patients with stage 3 or 4 solid tumors (TMN classification, group staging), hematologic malignancies with high tumor burden, CNS cancer (WHO stage 3 and 4)unless significant tumor mass was removed near occurence of shock.
·Patients with dead bowel likely to result in death. After surgical removal of 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 with anaphylactic shock
·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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified