A Prospective, Multi-Centric, Randomized, Double-Blind, Parallel, Phase-III Study to AssessEfficacy of PMZ-2010 as a Resuscitative Agent for Hypovolemic Shock to be Used as an Adjuvant to Standard Shock Treatment.

Pharmazz India Private Limited0 个研究点目标入组 105 人开始时间: 待定最近更新: 2023年2月6日

试验速览

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•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.

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