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

This study has been completed.
Sponsor:
Information provided by:
Apex Bioscience
ClinicalTrials.gov Identifier:
NCT00021502
First received: July 18, 2001
Last updated: August 13, 2009
Last verified: August 2009
  Purpose

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 Intervention Phase
Shock
Systemic Inflammatory Response Syndrome
Drug: pyridoxalated hemoglobin polyoxyethylene conjugate (PHP)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Apex Bioscience:

Estimated Enrollment: 1000
Study Start Date: March 2001
Study Completion Date: May 2004
Primary Completion Date: August 2003 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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):

  • 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00021502     History of Changes
Other Study ID Numbers: APX-PHP 99-004
Study First Received: July 18, 2001
Last Updated: August 13, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Apex Bioscience:
Pyridoxalated hemoglobin polyoxyethylene conjugate (PHP)
Systemic Inflammatory Response Syndrome (SIRS)
Nitric oxide (NO)
Shock

Additional relevant MeSH terms:
Shock
Syndrome
Systemic Inflammatory Response Syndrome
Disease
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on October 30, 2014