Polydatin Injectable (HW6) for Shock Treatment
Raktažodžiai
Santrauka
Datos
Paskutinį kartą patikrinta: | 12/31/2012 |
Pirmasis pateikimas: | 01/28/2013 |
Numatytas registravimas pateiktas: | 01/28/2013 |
Pirmas paskelbtas: | 01/29/2013 |
Paskutinis atnaujinimas pateiktas: | 01/28/2013 |
Paskutinis atnaujinimas paskelbtas: | 01/29/2013 |
Faktinė studijų pradžios data: | 01/31/2013 |
Numatoma pirminio užbaigimo data: | 08/31/2014 |
Numatoma studijų užbaigimo data: | 11/30/2014 |
Būklė ar liga
Intervencija / gydymas
Drug: Polydatin Injectable (HW6)
Fazė
Rankų grupės
Ranka | Intervencija / gydymas |
---|---|
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 (HW6) 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. |
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 |
Tinkamumo kriterijai
Amžius, tinkami studijuoti | 18 Years Į 18 Years |
Tinkamos studijoms lytys | All |
Priima sveikus savanorius | Taip |
Kriterijai | Inclusion Criteria: - Adult males or females aged 18-80 years. - 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, ongoing, or projected Standard of Care or surgery. - Patients (or its relative) who have signed Informed Consent Form to voluntarily participate in this clinical study. Exclusion Criteria: - Has known allergic constitution or history of alcohol or drug allergy. or - Complicating acute cardiac failure, acute renal failure, acute liver failure or disseminated intravascular coagulation (DIC). or - Pregnant or lactating women. or - Complicating moderate to severe craniocerebral injury. or - Has known previous severe chronic disease(s) in liver, kidney, carvascualr system or central nervous system. or |
Rezultatas
Pirminės rezultatų priemonės
1. The time length (TL) between the start of HW6 administration to the onset of the first TS. [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]
Antrinės rezultatų priemonės
1. The amount and duration of total vasopressor(s) used during this TL period [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]
2. The degree of fluid dependence [from the start of testing drug to the OTS]
3. Metabolic indicators [Within 6 days]
4. Severity of organ dysfunction in the ICU [Daily during the administration stay after enrollment]
5. Duration of ICU stay [The total time (in hours) of ICU admission from the day of administration to day 7 (7 days)]
6. 28-day survival [From the end of drug administration to Day 28]
Kitos rezultato priemonės
1. Fluid intake and output volume [Every 24h for 5 days]