A Prospective, Multi-Centric, Randomized, Double-Blind, Parallel, Phase-III Study to AssessEfficacy of PMZ-2010 as a Resuscitative Agent for Hypovolemic Shock to be Used as an Adjuvant to Standard Shock Treatment.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 19
- 主要终点
- 1. Change in systolic and diastolic blood pressure, Mean through 48 hours.
研究概览
简要总结
This is a prospective, multi-centric, randomized, double-blind, parallel, controlled phase-III efficacy clinical study of PMZ-2010 therapy in patients with Hypovolemic shock with systolic arterial blood pressure ≤ 90 mmHg at presentation and continue to receive standard Shock Treatment. The enrolment period of the study will be approximately 09 months and total duration of the study will be approximately 15 months. For an individual patient, duration of the study will be 1 month (28 days), including 2 study visits: visit 1/Day 1 (screening/randomization/baseline/treatment visit), and visit 2/End of Study (Day 28 + 7). At visit 1, approximately 105 patients will be randomized 2:1 into 2 treatment groups after meeting the eligibility criteria. Total 70 patients will be enrolled in PMZ-2010 group (Group 1) and in Normal Saline group (Group 2) total 35 patients will be enrolled.
• Group 1: PMZ-2010 (Dose: 0.01 mg/kg) + Standard of care
• Group 2: Normal Saline (Dose: Equal volume) + Standard of care
In both treatment groups, patients will be provided the standard of care. PMZ-2010 or Normal Saline will be administered intravenously after randomization to hypovolemic shock patients with systolic arterial blood pressure ≤ 90 mmHg at presentation and continue to receive standard Shock Treatment. In PMZ-2010 group, dose of PMZ-2010 (0.01 mg/kg) will be administered as an intravenous (IV) infusion over 1 hour in 100 mL of normal saline. Second dose of PMZ-2010 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. PMZ-2010 administration if needed will continue for two days post randomization. Minimum 1 dose or maximum 6 doses of PMZ-2010 will be administered within first 48 hours. post randomization. In Control group, single dose of equal volume of Normal Saline will be administered as intravenous (IV) infusion over 1 hour in 100 mL of normal saline post randomization. Condition of administration will remain same as for PMZ-2010 group. Each patient will be monitored closely throughout his/her hospitalization and will be followed until discharge from randomization. Each patient will be assessed for efficacy parameters over 28 days from randomization to a clinic visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult males or females aged 18 years or older.
- •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 the particular hospital setup.
- •Blood Lactate level indicative of hypovolemic shock.
排除标准
- •Development of any other terminal illness not associated with Hypovolemic shock during the 28-day observation period.
- •Patient with altered consciousness not due to Hypovolemic shock.
- •Known pregnancy.
- •Cardiopulmonary resuscitation (CPR) before randomization.
- •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: cancer, chronic renal failure, liver failure, decompensated heart failure or AIDS.
结局指标
主要结局
1. Change in systolic and diastolic blood pressure, Mean through 48 hours.
时间窗: Through first 48 hours.
2. Change in blood lactate, Mean through 48 hours.
时间窗: Through first 48 hours.
3. Change in Base-deficit, Mean through 48 hours.
时间窗: Through first 48 hours.
次要结局
- Days in hospital, in ICU and/or on Ventilator(The number of days beginning with the day of the episode counted as “Day 0†through Day 28 during which the patient is being cared in the hospital, or on ventilator or in ICU)
- Total Urine Output(First 48 hours)
- Amount of total vasopressor(s) infused(First 48 hours)
- Total volume of fluid administered inclusive of crystalloids, blood products, mannitol and other colloids.(First 48 hours)
- Proportion of patients with all-cause mortality(At 48 hours and 28 days)
- Number of doses of PMZ-2010 administered post randomization(First 48 hours)
- Change in Multiple Organ Dysfunction Syndrome Score (MODS)(28 days)
- Change in Acute Respiratory Distress Syndrome (ARDS) Free Survival(28 days)
- Change in Glasgow coma score(28 days)
- Proportion of patients with adverse events (AEs) and serious adverse events (SAEs).(28 days)