Back to resultsSafety and Efficacy of PHP in the Treatment of Shock Associated With Systemic Inflammatory Response Syndrome (SIRS)
Primary Purpose
Shock, Systemic Inflammatory Response Syndrome
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
pyridoxalated hemoglobin polyoxyethylene conjugate (PHP)
Sponsored by
About this trial
This is an interventional treatment trial for Shock focused on measuring Pyridoxalated hemoglobin polyoxyethylene conjugate (PHP), Systemic Inflammatory Response Syndrome (SIRS), Nitric oxide (NO), Shock
Eligibility 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.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00021502
Brief Title
Safety and Efficacy of PHP in the Treatment of Shock Associated With Systemic Inflammatory Response Syndrome (SIRS)
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 Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
March 2001 (undefined)
Primary Completion Date
August 2003 (Actual)
Study Completion Date
May 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Apex Bioscience
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shock, Systemic Inflammatory Response Syndrome
Keywords
Pyridoxalated hemoglobin polyoxyethylene conjugate (PHP), Systemic Inflammatory Response Syndrome (SIRS), Nitric oxide (NO), Shock
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
pyridoxalated hemoglobin polyoxyethylene conjugate (PHP)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
12. IPD Sharing Statement
Citations:
PubMed Identifier
18552688
Citation
Kinasewitz GT, Privalle CT, Imm A, Steingrub JS, Malcynski JT, Balk RA, DeAngelo J. Multicenter, randomized, placebo-controlled study of the nitric oxide scavenger pyridoxalated hemoglobin polyoxyethylene in distributive shock. Crit Care Med. 2008 Jul;36(7):1999-2007. doi: 10.1097/CCM.0b013e31817bfe84.
Results Reference
result
Learn more about this trial
Safety and Efficacy of PHP in the Treatment of Shock Associated With Systemic Inflammatory Response Syndrome (SIRS)
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