Health Condition 1: null- Hypovolemic shock due to blood loss Health Condition 2: T794- Traumatic shock
Conditions
Interventions
Intervention1: Lyophilized Centhaquin Injection
(PMZ-2010)
: PMZ-2010 (Dose: 0.01 mg/kg) + Standard of care: PMZ-2010 will be administered intravenously after randomization to hypovolemic shock patien
Sponsors
Pharmazz India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: a. 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 c.Body weight 45 kg â?? 85 kg d. Estimated time from injury to randomization e. Subject is 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
Exclusion criteria
Exclusion criteria: a. Terminal illness b. Development of any other terminal illness not associated with Hypovolemic shock during the 28 day observation period. c. Evidence of severe blunt or penetrating head injury with a Glasgow Coma Scale (GCS) 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with adverse events (AEs) and serious adverse events (SAEs)Timepoint: 28 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| Total Blood product requirements and total amount of blood products required (packed red blood cells (PRBC), fresh frozen plasma (FFP), platelets, cryoprecipitate.Timepoint: First 48 hours.;Total fluids requirement and total volume of fluid administered (inclusive of crystalloids, blood products, 3% saline, mannitol and other colloids).Timepoint: First 48 hours.;Amount and duration of total vasopressor(s) infused.Timepoint: First 48 hours.;Change in Adult Respiratory Distress Syndrome (ARDS) Free Survival.Timepoint: 28 days;Change in Base-deficit.Timepoint: First 48 hours.;Change in blood hematocrit and hemoglobin.Timepoint: First 48 hours.;Change in blood lactate.Timepoint: First 48 hours.;Change in Coagulation parameters (Platelets, Prothrombin time, INR and fibrinogen values).Timepoint: First 48 hours.;Change in Glasgow outcome score.Timepoint: 28 days;Change in Hemodynamic variables.Timepoint: First 48 hours.;Change in Multiple Organ Dysfunction Score (MODS).Timepoint: 28 days;Days in hospital, in ICU and/or on Ventilator.Timepoint: The number of days beginning with the day of the episode counted as â??Day 0â?? through Day 28 during which the patient is being cared in the hospital, or on ventilator or in ICU.;Number of doses of PMZ-2010 administered.Timepoint: First 48 hours.;Proportion of subjects discharged from hospital. Timepoint: Through Day 28 and alive at the Day 28 Follow up visit.;Proportion of subjects with all cause mortality.Timepoint: At 48 hours and 28 days. | — |
Countries
India
Contacts
Public ContactMr Sunil Gulati
Pharmazz India Private Limited
Outcome results
None listed