IRB Number
|
# 23592
|
| Description |
A Phase III trial where Eritoran
Tetrasodium vs. placebo is given to critically ill patients within 12 hours
of onset of sepsis. Drug is purported to prevent the cytokine release that
initiates the chain of events causing the severe side effects in sepsis. |
| What is expected of me? |
Patients will be administered the
drug in a dedicated central line, will have a physical exam, daily vital
signs, blood work drawn at periodic intervals, and EKG’s at timed intervals
up to discharge or Day 28 whichever occurs first. There will be three
follow-up phone calls at 3, 6 and 12 months for quality of life and patient
disposition status. |
| Inclusion Criteria |
- >18 yo
- Onset of sepsis within 12 hrs
- One organ dysfunction
- Full patient support
|
| Exclusion Criteria |
- Pregnancy
- Extensive burns
- Immunosuppressive therapy
- CPR within 4 weeks
- HIV+
- Significant hepatic impairment
- Weight >150 kg
|
| Length of Study |
Patients will be carefully
monitored in the ICU until D/C then long-term follow up to 12 months. Study
is to end approximately when 2000 patients are enrolled. |
| Study Location |
Penn State Milton S. Hershey
Medical Center |
| Investigator Information |
Daniel E. Carney, MD
Trauma/Critical Care |
| To obtain more information about this study please contact: |
Daniel E. Carney, MD
717-531-3564
dcarney@psu.edu, or
Lee Ann Smith, RN
717-531-0003 ext. 285155
lsmith1@psu.edu |
