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Safety and Efficacy of PHP in the Treatment of Shock Associated with Systemic Inflammatory Response Syndrome (SIRS) Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Safety and Efficacy of PHP in the Treatment of Shock Associated with Systemic Inflammatory Response Syndrome (SIRS) conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Safety and Efficacy of PHP in the Treatment of Shock Associated with Systemic Inflammatory Response Syndrome (SIRS) Clinical research trials and Safety and Efficacy of PHP in the Treatment of Shock Associated with Systemic Inflammatory Response Syndrome (SIRS) health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Safety and Efficacy of PHP in the Treatment of Shock Associated with Systemic Inflammatory Response Syndrome (SIRS). Safety and Efficacy of PHP in the Treatment of Shock Associated with Systemic Inflammatory Response Syndrome (SIRS) Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Safety and Efficacy of PHP in the Treatment of Shock Associated with Systemic Inflammatory Response Syndrome (SIRS) clinical trial. Human subjects often get the best healthcare available for their Safety and Efficacy of PHP in the Treatment of Shock Associated with Systemic Inflammatory Response Syndrome (SIRS) condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Safety and Efficacy of PHP in the Treatment of Shock Associated with Systemic Inflammatory Response Syndrome (SIRS)  Safety and Efficacy of PHP in the Treatment of Shock Associated with Systemic Inflammatory Response Syndrome (SIRS)
Safety and Efficacy of PHP in the Treatment of Shock Associated with Systemic Inflammatory Response Syndrome (SIRS)
For Condition: Shock,Systemic Inflammatory Response Syndrome
Status: Recruiting
Sponsor(s): Apex Bioscience ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Randomized, Open Label, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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) /= 90 beats/minute, - Either hyperthermia >/= 38 degrees C, or hypothermia /= 12,000 cells/mm3, /= 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.
Total Enrollment: 1000
Location and Contact Information:
PPD Development *Recruiting*
Morrisville, North Carolina, 27560
United States
Recruiting Micheal Brooks 919-462-4897
Additional Information:
Study ID Numbers: APX-PHP 99-004;
Study Start Date: March 2001
Record last reviewed: May 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00021502
Other Systemic Inflammatory Response Syndrome Studies:
1. Safety and Efficacy of PHP in the Treatment of Shock Associated with Systemic Inflammatory Response Syndrome (SIRS)
Related Studies:
Other Systemic Inflammatory Response Syndrome Clinical Trials
Other North Carolina Clinical Trials
Other Morrisville Clinical Trials
Safety and Efficacy of PHP in the Treatment of Shock Associated with Systemic Inflammatory Response Syndrome (SIRS)
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