Effect of PMZ-2010 in Hypovolemic Shock patients.
- Conditions
- Health Condition 1: T300- Burn of unspecified body region, unspecified degreeHealth Condition 2: O721- Other immediate postpartum hemorrhageHealth Condition 3: I978- Other intraoperative and postprocedural complications and disorders of the circulatory system, not elsewhere classifiedHealth Condition 4: T811- Postprocedural shockHealth Condition 5: O083- Shock following ectopic and molarpregnancyHealth Condition 6: T794- Traumatic shock
- Registration Number
- CTRI/2019/01/017196
- Lead Sponsor
- Pharmazz India Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 105
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 <= 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.
3. Blood Lactate level indicative of hypovolemic shock.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Change in systolic and diastolic blood pressure, Mean through 48 hours. <br/ ><br>2. Change in blood lactate, Mean through 48 hours. <br/ ><br>3. Change in Base-deficit, Mean through 48 hours.Timepoint: Through first 48 hours.
- Secondary Outcome Measures
Name Time Method 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