A Prospective, Multi-Centric, Randomized, Double-Blind, Parallel, Phase-III Study to Assess Efficacy 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
- 18
- 主要终点
- Change in base-deficit
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.
Centhaquine (previously used names, centhaquin and PMZ-2010; International Non-proprietary Name (INN) recently approved by WHO is centhaquine) has been found to be an effective resuscitative agent in rat, rabbit and swine models of hemorrhagic shock, it decreased blood lactate, increased mean arterial pressure, cardiac output, and decreased mortality. An increase in cardiac output during resuscitation is mainly attributed to an increase in stroke volume. Centhaquine acts on the venous α2B-adrenergic receptors and enhances venous return to the heart, in addition, it produces arterial dilatation by acting on central α2A-adrenergic receptors to reduce sympathetic activity and systemic vascular resistance.
详细描述
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
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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. Blood Lactate level indicative of hypovolemic shock (>2.0 mmol/L).
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.
研究组 & 干预措施
Normal Saline
Hypovolemic shock patients will be provided the standard of care. Following randomization 100 ml (equal volume to experimental arm) of normal saline will be administered intravenously over 1 hour.
干预措施: Normal saline + Standard Treatment (Drug)
PMZ-2010 (centhaquine)
Hypovolemic shock patients will be provided the standard of care. Following randomization PMZ-2010 (0.01 mg/kg) will be administered intravenously over 1 hour in 100 mL of normal saline.
干预措施: Centhaquine + Standard Treatment (Drug)
结局指标
主要结局
Change in base-deficit
时间窗: 48 hours
Change in Base-deficit - Mean through 48 hours
Change in systolic and diastolic blood pressure
时间窗: 48 hours
Change in systolic and diastolic blood pressure - Mean through 48 hours
Change in blood lactate level
时间窗: 48 hours
Change in blood lactate level - Mean through 48 hours
次要结局
- Stay in hospital, in ICU and/or on Ventilator(28 days)
- Change in Glasgow coma score(28 days)
- Incidence of mortality(28 days)
- Total Urine Output(48 hours)
- Vasopressor(s) infused(48 hours)
- Volume of fluid administered(48 hours)
- Change in Multiple Organ Dysfunction Syndrome Score(28 days)
- Incidence of adverse events(28 days)
- Doses of study drug(48 hours)
- Change in Acute Respiratory Distress Syndrome(28 days)