Safety and Efficacy of PHP in the Treatment of Shock Associated With Systemic Inflammatory Response Syndrome (SIRS)
|ClinicalTrials.gov Identifier: NCT00021502|
Recruitment Status : Completed
First Posted : July 20, 2001
Last Update Posted : August 14, 2009
|Condition or disease||Intervention/treatment||Phase|
|Shock Systemic Inflammatory Response Syndrome||Drug: pyridoxalated hemoglobin polyoxyethylene conjugate (PHP)||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Primary Completion Date :||August 2003|
|Study Completion Date :||May 2004|