A prospective, multi-centric, open-labeled, phase-IV study to assess safety and efficacy of LYFAQUINâ„¢ (Centhaquine citrate) as a resuscitative agent for hypovolemic shock to be used as an adjuvant to standard treatment of shock.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 23
- 主要终点
- The proportion of patients with adverse events (AEs) and serious adverse events (SAEs)
研究概览
简要总结
This prospective, multi-centric, open-labeled, Phase-IV study to assess safety and efficacy of LYFAQUINTM (Centhaquine Citrate) as a resuscitative agent for hypovolemic shock to be used as an adjuvant to standard treatment of shock.
This study is designed to collect post-authorization safety data of LYFAQUINTM (Centhaquine Citrate), a novel first-in-class drug to treat life-threatening condition of hypovolemic shock with unmet need.
Results of clinical phase II and phase III studies indicate that, LYFAQUINâ„¢ (Centhaquine citrate) is a novel, first-in-class, highly effective resuscitative agent for hypovolemic shock. Phase II results demonstrate highly significant efficacy in improving blood pressure (p<0.0001), lactate levels (p=0.0012) and base-deficit (p<0.0001). There was also an improvement in reduction in use of vasopressors and reduced mortality. Similarly, results of phase III study confirmed the safety and efficacy of LYFAQUINTM as an adjuvant to standard of care for hypovolemic shock. Therefore, to assess safety of LYFAQUINTM in large population a phase IV study (post-authorization safety study) has been designed.
Sample size: for this single arm study is total of 400 patients will be enrolled in the study.
The enrolment period of the study will be approximately 12 months and total duration of the study will be approximately 15 months. For an individual patient, duration of the study will be from his/her enrolment to time of discharge or 7 days (whichever is earlier). Visit 1/day 1 (screening/enrollment baseline/treatment visit) and follow patient till discharge or day 7 (end of study) whichever is earlier.
Treatment Arm: LYFAQUINTM (Dose: 0.01 mg/kg) + Standard of care
All patients will be provided the standard of care along with the study drug LYFAQUINTM. LYFAQUINTM will be administered intravenously after enrollment to hypovolemic shock patients with systolic arterial blood pressure ≤ 90 mmHg at presentation and continue to receive standard shock treatment.
Dossing:
LYFAQUINTM will be administered at a dose of 0.01 mg/kg of body weight, as an intravenous (IV) infusion over 1 hour in 100 mL of normal saline. Second dose of LYFAQUINTM will be administered if SBP falls below or remains below or equal to 90 mmHg but not before 4 hours of previous dose and total doses per day (in 24 hours) will not exceed 3 doses. LYFAQUINTM administration if needed will continue for two days post enrollment. Minimum 1 dose or maximum 6 doses of LYFAQUINTM will be administered within first 48 hours post enrollment. Each patient will be monitored closely throughout his/her hospitalization and will be followed until discharge or day 7 (whichever is earlier) from enrollment. Each patient will be assessed for safety and efficacy parameters as per study schedule.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Adult males or females aged 18 years or older.
- •2.Patients with hypovolemic shock admitted to the emergency room or ICU with systolic blood pressure ≤ 90 mmHg at presentation and continue to receive standard shock treatment (endotracheal intubation; fluid resuscitation and vasopressors).
- •Standard of care to be provided to the patients shall be the one used in each hospital setup.
- •3.Blood Lactate level indicative of hypovolemic shock with lactate level more than 2 mmol/L.
排除标准
- •Development of any other terminal illness not associated with hypovolemic shock during study duration.
- •Patient with altered consciousness not due to hypovolemic shock and comatose patient.
- •Known pregnancy.
- •Cardiopulmonary resuscitation (CPR) before enrollment.
- •Presence of a do not resuscitate order.
- •Patient is participating in another interventional study.
- •Patients with systemic diseases which were already present before having trauma, such as: sepsis, cancer, chronic renal failure, liver failure, decompensated heart failure or AIDS.
- •Decision to be made by the investigator.
结局指标
主要结局
The proportion of patients with adverse events (AEs) and serious adverse events (SAEs)
时间窗: Each patient will be monitored closely throughout his/her hospitalization and will be followed until discharge or day 7 (whichever is earlier) from enrollment
次要结局
- Change in blood lactate, Mean through 48 hours(first 48 hours)
- Incidence of mortality(at the time of discharge or day)
- Multiple Organ Dysfunction Syndrome score (MODS); Mean through day 7 or at the time of discharge(At the time of discharge or day 7)
- Acute Respiratory Distress Syndrome (ARDS); Mean through day 7 or at the time of discharge(At the time of discharge or day 7)
- Glasgow Coma Scale (GCS); Mean through day 7 or at the time of discharge(At the time of discharge or day 7)
- Systolic and diastolic blood pressure; Mean through 48 hours and at the time of discharge or day 7.(first 48 hours and at the time of discharge or day 7)
- Base-deficit; Mean through 48 hours(first 48 hours)
- Time in intensive care unit (ICU)(At the time of discharge or day 7)
- Time on ventilator(at the time of discharge or day 7)
- Urine output during the first 48 hours(first 48 hours)