Safety and Efficacy of PHP in the Treatment of Shock Associated With Systemic Inflammatory Response Syndrome (SIRS)
|Shock Systemic Inflammatory Response Syndrome||Drug: pyridoxalated hemoglobin polyoxyethylene conjugate (PHP)||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase 3, Multi-Center, Randomized, Placebo Controlled Study of PHP When Administered by Continuous Infusion in Patients With Shock Associated With Systemic Inflammatory Response Syndrome (SIRS)|
|Study Start Date:||March 2001|
|Study Completion Date:||May 2004|
|Primary Completion Date:||August 2003 (Final data collection date for primary outcome measure)|
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:
- all cause mortality,
- median patient survival time and
- adverse event rates and duration.