Health Condition 1: T300- Burn of unspecified body region, unspecified degree Health Condition 2: O721- Other immediate postpartum hemorrhage Health Condition 3: I978- Other intraoperative and postprocedural complications and disorders of the circulatory system, not elsewhere classified Health Condition 4: T811- Postprocedural shock Health Condition 5: O083- Shock following ectopic and molarpregnancy Health Condition 6: T794- Traumatic shock
Conditions
Interventions
Intervention1: Lyophilized Centhaquin citrate Injection 1.0 mg/vial (PMZ-2010): PMZ-2010 (Dose: 0.01 mg/kg) + Standard of care:
PMZ-2010 will be administered intravenously after randomization to hypov
Sponsors
Pharmazz India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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 3. Blood Lactate level indicative of hypovolemic shock.
Exclusion criteria
Exclusion criteria: 1. Development of any other terminal illness not associated with Hypovolemic shock during the 28-day observation period. 2. Patient with altered consciousness not due to Hypovolemic shock. 3. Known pregnancy. 4. Cardiopulmonary resuscitation (CPR) before randomization. 5. Presence of a do not resuscitate order. 6. Patient is participating in another interventional study. 7. Patients with systemic diseases which were already present before having trauma, such as: cancer, chronic renal failure, liver failure, decompensated heart failure or AIDS.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in systolic and diastolic blood pressure, Mean through 48 hours. 2. Change in blood lactate, Mean through 48 hours. 3. Change in Base-deficit, Mean through 48 hours.Timepoint: Through first 48 hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| Amount of total vasopressor(s) infusedTimepoint: First 48 hours;Change in Acute Respiratory Distress Syndrome (ARDS) Free SurvivalTimepoint: 28 days;Change in Glasgow coma scoreTimepoint: 28 days;Change in Multiple Organ Dysfunction Syndrome Score (MODS)Timepoint: 28 days;Days in hospital, in ICU and/or on VentilatorTimepoint: 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 post randomizationTimepoint: First 48 hours;Proportion of patients with adverse events (AEs) and serious adverse events (SAEs).Timepoint: 28 days;Proportion of patients with all-cause mortalityTimepoint: At 48 hours and 28 days;Total Urine OutputTimepoint: First 48 hours;Total volume of fluid administered inclusive of crystalloids, blood products, mannitol and other colloids.Timepoint: First 48 hours | — |
Countries
India
Contacts
Public ContactMr Sunil Gulati
Pharmazz India Private Limited
Outcome results
None listed