Hypovolemic Shock Clinical Trial
Official title:
A Prospective, Multi-Centric, Randomized, Double-Blind, Parallel, Phase-III Study to Assess Efficacy of PMZ-2010 as a Resuscitative Agent for Hypovolemic Shock to be Used as an Adjuvant to Standard Shock Treatment
This is a prospective, multi-centric, randomized, double-blind, parallel, controlled
phase-III efficacy clinical study of PMZ-2010 therapy in patients with hypovolemic shock.
Centhaquine (previously used names, centhaquin and PMZ-2010; International Non-proprietary
Name (INN) recently approved by WHO is centhaquine) has been found to be an effective
resuscitative agent in rat, rabbit and swine models of hemorrhagic shock, it decreased blood
lactate, increased mean arterial pressure, cardiac output, and decreased mortality. An
increase in cardiac output during resuscitation is mainly attributed to an increase in stroke
volume. Centhaquine acts on the venous α2B-adrenergic receptors and enhances venous return to
the heart, in addition, it produces arterial dilatation by acting on central α2A-adrenergic
receptors to reduce sympathetic activity and systemic vascular resistance.
Approximately 105 patients will be randomized 2:1 into 2 treatment groups after meeting the
eligibility criteria. Total 70 patients will be enrolled in PMZ-2010 group (Group 1) and in
Normal Saline group (Group 2) total 35 patients will be enrolled.
- 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 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 at presentation and continue to receive
standard Shock Treatment. In PMZ-2010 group, dose of PMZ-2010 (0.01 mg/kg) will be
administered as an intravenous (IV) 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 or
equal to 90 mmHg but not before 4 hours of previous dose and total doses per day (in 24
hours) 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 hours. post randomization. In Control group, single dose of
equal volume of Normal Saline will be administered as intravenous (IV) infusion over 1
hour in 100 mL of normal saline post randomization. Condition of administration will
remain same as for PMZ-2010 group. Each patient will be monitored closely throughout
his/her hospitalization and will be followed until discharge from randomization. Each
patient will be assessed for efficacy parameters over 28 days from randomization to a
clinic visit.
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