Safety and Efficacy of PHP in the Treatment of Shock Associated With Systemic Inflammatory Response Syndrome (SIRS)
Study Details
Study Description
Brief Summary
To determine the safety and effectiveness of pyridoxylated hemoglobin polyoxyethylene conjugate (PHP) administered by continuous intravenous (IV) infusion in systemic inflammatory response syndrome (SIRS) patients with shock. PHP is a human-derived chemically modified hemoglobin preparation. PHP selectively scavenges excess nitric oxide (NO) and does so in a catalytic, concentration-dependent reaction that results in the formation of the non-toxic NO metabolite, nitrate. PHP is postulated to reduce excess, toxic levels of NO while allowing critical beneficial levels of the molecule to persist.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 3 |
Detailed Description
This Phase 3, randomized, placebo controlled, multi-center study is designed to evaluate the safety and efficacy of continuous IV infusion of PHP plus conventional vasopressor treatment, as compared to continuous IV infusion of Plasma-Lyte A plus conventional vasopressor, as a treatment for restoring hemodynamic stability in SIRS patients with shock. Conventional vasopressors include dopamine > 5 mcg/kg/min; or norepinephrine, phenylephrine or epinephrine at any dose.
The study consists of a Screening period, a Pre-Treatment period, and a 28-day Treatment period. Efficacy will be determined by evaluating objective clinical measures of mortality and organ function over the 28-day treatment period.
The safety and tolerability of PHP will be evaluated over the continuous 28 days using a number of measures including an evaluation of:
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all cause mortality,
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median patient survival time and
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adverse event rates and duration.
Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Determination of study eligibility will be made by the Investigator on the basis of the inclusion criteria listed below:
SIRS Inclusion Criteria
Patients with SIRS as characterized by two or more of the following conditions (worst values in a 24 hour period):
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Either respiratory rate >/= 20 breaths/minute, partial pressure of arterial carbon dioxide (PaCO2) </= 32 torr, or mechanical ventilation,
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Heart rate >/= 90 beats/minute,
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Either hyperthermia >/= 38 degrees C, or hypothermia </= 36 degrees C or
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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 (PCWP >/= 12mmHg) and with one or more conventional vasopressors (continuing up to the time of randomization) being used to treat hypotension (MBP < 60 mmHg or SBP < 90 mmHg). Patients cannot be entered if they have been in shock for more than 24 hours.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Apex Bioscience
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- APX-PHP 99-004