Polydatin Injectable (HW6) for Shock Treatment (PIST)
HW6 can prolong animal's survival time and increase the survival rate. HW6 enhances cardiac function, improves microcirculation, and increases blood pressure and pulse pressure, and improves blood perfusion of important organs; HW6's anti-shock activity comes from a combined multiple target pharmacological effects.
Based on a completed phase II trial conducted in China, HW6 can effectively treatment shock patient.
This is a phase II clinical study to further evaluate the efficacy and safety of Polydatin Injectable 100mg/5mL/via (HW6) in the treatment of shock in the United States. Patients with traumatic/hemorrhagic shock or septic shock admitted to the emergency room or ICU with systolic blood pressure < 90mmHg, or is on vasopressor(s) for systolic blood pressure stabilization, regardless the types of completed, on-going, or projected Standard of Care or surgery will be recruited to participant in the trial. A total of 120 patients with traumatic/hemorrhagic shock and 120 patients with septic shock will be enrolled. For each type of shock, sixty patients each will be in test group and control group. Both adult males and females aged 18-80 years are eligible. The primary clinical endpoint is the time length (TL) between the start of HW6 administration to the onset of the first treatment success, that is: the systolic blood pressure is stabilized at ≥90mmHg and MAP≥65mmHg for 1 hour without the use of vasopressors. Several secondary endpoints and biomarkers will be measured.
Efficacy data will be compared using group t-test or Wilcoxon log-rank test between treatment groups and placebo groups. Safety data will also be reported accordingly.
Drug: Polydatin Injectable
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-Blind, Placebo Controlled, Parallel Group Multi-Center Phase II Clinical Study to Evaluate the Efficacy and Safety of HW6 in the Treatment of Traumatic/Hemorrhagic Shock and Septic Shock|
- The time length (TL) between the start of HW6 administration to the onset of the first TS. [ Time Frame: From the start of drug administration to the onset of TS (OTS) where the first systolic blood pressure≥90mmHg and MAP≥65mmHg is observed in the 7 consecutive measures ] [ Designated as safety issue: No ]
Treatment success (TS): the systolic blood pressure is stabilized at ≥90mmHg and MAP≥65mmHg for 1 hour without the use of vasopressor(s).
Blood pressure will be recorded every 10 min. Treatment success is considered to have been achieved when 7 consecutive systolic blood pressure to be≥90mmHg and MAP≥65mmHg.
The TL is the time from the start of drug administration to the onset of TS (OTS) where the first systolic blood pressure≥90mmHg and MAP≥65mmHg is observed in the 7 consecutive measures.
Blood pressure will be measured every hour after the TS. If blood pressure become unstable, standard care will be in practice.
- The amount and duration of total vasopressor(s) used during this TL period [ Time Frame: From the start of drug administration to the onset of TS (OTS) where the first systolic blood pressure≥90mmHg and MAP≥65mmHg is observed in the 7 consecutive measures ] [ Designated as safety issue: No ]
Observation period: From start of study drug treatment to OTS. Record the details of the use of vasopressor(s) during TL for each subject, including name of medication, infusion concentration and rate, and the duration of each concentration and rate being maintained.
Duration of vasopressor(s) use: accurate to the minute, or by the cumulative time of each administration if used intermittently.
Total dose of vasopressor(s)：The total dose of each vasopressor.
- The degree of fluid dependence [ Time Frame: from the start of testing drug to the OTS ] [ Designated as safety issue: No ]
- Metabolic indicators [ Time Frame: Within 6 days ] [ Designated as safety issue: No ]Arterial blood lactate, lactate clearance, oxygen saturation mixed venous blood, blood gas levels
- Severity of organ dysfunction in the ICU [ Time Frame: Daily during the administration stay after enrollment ] [ Designated as safety issue: No ]Compare the changes in SOFA score during the administration stay between the two groups to assess the protective effect of the study drug on vital organs.
- Duration of ICU stay [ Time Frame: The total time (in hours) of ICU admission from the day of administration to day 7 (7 days) ] [ Designated as safety issue: No ]
- 28-day survival [ Time Frame: From the end of drug administration to Day 28 ] [ Designated as safety issue: No ]
- Fluid intake and output volume [ Time Frame: Every 24h for 5 days ] [ Designated as safety issue: No ]
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Experimental: Polydatin Injectable (HW6)
10ml(2 ampoules) diluted in 500ml of 0.9% NaCl solution for i.v. infusion over 2 hours; once daily for 5 consecutive days
Drug: Polydatin Injectable
Dilute two 100mg/5mL vials of HW6 into 500mL 0.9% NaCl injection and administer as i.v. infusion over 2 hours. The drug should be given as early as possible right after the IC Form is signed on Day 1, and once every 24 hours for additional 4 doses.
Other Name: HW6
Placebo Comparator: HW6 blank dummy (0.9%NaCl)
10ml (2 ampoules) diluted in 500ml of 0.9% NaCl solution for i.v. infusion over 2 hours; once daily for 5 consecutive days
Please refer to this study by its ClinicalTrials.gov identifier: NCT01780129
|Contact: SUN Henry, PHD||(301) firstname.lastname@example.org|
|United States, Delaware|
|Christiana Care||Not yet recruiting|
|Newark, Delaware, United States, 19718|
|Contact: GERARD FULDA, PhD 302-733-4260 email@example.com|
|Principal Investigator: GERARD FULDA, PhD|
|Study Chair:||YU Lin, PhD||Neptunus Pharmaceuticals Inc.|