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Safety and Efficacy of PHP in the Treatment of Shock Associated With Systemic Inflammatory Response Syndrome (SIRS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00021502
Recruitment Status : Completed
First Posted : July 20, 2001
Last Update Posted : August 14, 2009
Information provided by:
Apex Bioscience

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
Shock Systemic Inflammatory Response Syndrome Drug: pyridoxalated hemoglobin polyoxyethylene conjugate (PHP) 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:

  • all cause mortality,
  • median patient survival time and
  • adverse event rates and duration.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 1000 participants
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
Actual Primary Completion Date : August 2003
Actual Study Completion Date : May 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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):

  • Either respiratory rate >/= 20 breaths/minute, partial pressure of arterial carbon dioxide (PaCO2) </= 32 torr, or mechanical ventilation,
  • Heart rate >/= 90 beats/minute,
  • Either hyperthermia >/= 38 degrees C, or hypothermia </= 36 degrees C or
  • 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.

Publications of Results:
Layout table for additonal information Identifier: NCT00021502    
Other Study ID Numbers: APX-PHP 99-004
First Posted: July 20, 2001    Key Record Dates
Last Update Posted: August 14, 2009
Last Verified: August 2009
Keywords provided by Apex Bioscience:
Pyridoxalated hemoglobin polyoxyethylene conjugate (PHP)
Systemic Inflammatory Response Syndrome (SIRS)
Nitric oxide (NO)
Additional relevant MeSH terms:
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Systemic Inflammatory Response Syndrome
Pathologic Processes