A Prospective, Multi-centric, Randomized, Double-blind, Parallel, Saline Controlled Phase II Safety and Efficacy study of PMZ-2010 as a resuscitative agent for Hypovolemic Shock dueto excessive blood loss to be used along with standard shock treatment.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 6
- 主要终点
- Proportion of subjects with adverse events (AEs) and serious adverse events (SAEs)
研究概览
简要总结
This is a prospective, multicentric, randomized, double- blind, parallel, saline controlled Phase II Safety and Efficacy clinical study of PMZ-2010 therapy in subjects with Hypovolemic shock due to blood loss with systolic arterial blood pressure < 90 mmHg after 10 min of standard Shock Treatment. A total of 50 subjects (25 in each arm) will be enrolled in the study. The enrolment period of the study will be approximately 03 months and total duration of the study will be approximately 09 months. For an individual subject, 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 + 5). At visit 1, approximately 50 subjects will be randomized 1:1 into 2 treatment groups after meeting the eligibility criteria:
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 best 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 even after 10 min of standard shock treatment. In PMZ-2010 group, dose of PMZ-2010 (0.01 mg/kg) will be administered as an intravenous 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 90 mmHg but not before 4 hours of previous dose and total doses per day 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 hrs post randomization. In Control group, single dose of equal volume of Normal Saline will be administered as intravenous infusion over 1 hour in 100 mL of normal saline post randomization. Condition of administration will remain same as for PMZ-2010 group. Each subject will be monitored closely throughout his/her hospitalization and will be followed until discharge from randomization. Each subject will be assessed for efficacy and safety 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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult males or females aged 18-60 years.
- •b.Patients with Hypovolemic shock due to blood loss admitted to the emergency room or ICU with systolic blood pressure <90 mmHg even after 10 min of standard shock treatment (endotracheal intubation; fluid resuscitation and vasopressors).
- •Standard care to be provided to the patients shall be the one used in the particular hospital setup.
- •c.Body weight 45 kg – 85 kg d.
- •Estimated time from injury to randomization <4 hours e.
- •Subject is <4 hours from time of Hypovolemic shock onset when the first dose of PMZ-2010 therapy is administered.
- •Time of onset is when symptoms began; Reasonable expectation of availability to receive the full PMZ-2010 course of therapy, and to be available for subsequent follow-up visits f.
- •Female subject is either: Not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) or, If of childbearing potential, agrees to use any of the following effective separate forms of contraception throughout the study, up to and including the follow-up visits: Condoms, sponge, foams, jellies, diaphragm or intrauterine device, or A vasectomised partner OR abstinence.
排除标准
- •Terminal illness b.
- •Development of any other terminal illness not associated with Hypovolemic shock during the 28 day observation period.
- •Evidence of severe blunt or penetrating head injury with a Glasgow Coma Scale (GCS) ≤ 8 d.
- •Type of injury is not known e.
- •Inability to obtain intravenous access f.Known pregnancy g.
- •Cardiopulmonary resuscitation (CPR) before randomization h.
- •Presence of a do not resuscitate order i.
- •Patient taking beta adrenergic antagonists j.
- •Untreated tension pneumothorax k.
- •Untreated cardiac tamponade l.Bilateral absent pupillary light reflex (both pupils fixed and dilated) m.
- •Patient is participating in another interventional study n.Presence of systemic diseases (cancer, chronic renal failure, liver failure, decompensated heart failure or AIDS) o.Patients with triad of coagulopathy, acidosis and hypothermia that requires immediate blood transfusion.
结局指标
主要结局
Proportion of subjects with adverse events (AEs) and serious adverse events (SAEs)
时间窗: 28 Days
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.)
- Proportion of subjects with all cause mortality.(At 48 hours and 28 days.)
- Total fluids requirement and total volume of fluid administered (inclusive of crystalloids, blood products, 3% saline, mannitol and other colloids).(First 48 hours.)
- Change in Hemodynamic variables.(First 48 hours.)
- Change in blood hematocrit and hemoglobin.(First 48 hours.)
- Change in blood lactate.(First 48 hours.)
- Change in Base-deficit.(First 48 hours.)
- Change in Coagulation parameters (Platelets, Prothrombin time, INR and fibrinogen values).(First 48 hours.)
- Proportion of subjects discharged from hospital.
- Total Blood product requirements and total amount of blood products required (packed red blood cells (PRBC), fresh frozen plasma (FFP), platelets, cryoprecipitate.(First 48 hours.)
- Amount and duration of total vasopressor(s) infused.(First 48 hours.)
- Number of doses of PMZ-2010 administered.(First 48 hours.)
- Change in Glasgow outcome score.(28 days)
- Change in Multiple Organ Dysfunction Score (MODS).(28 days)
- Change in Adult Respiratory Distress Syndrome (ARDS) Free Survival.(28 days)