Blood Loss Clinical Trial
Official title:
A Prospective, Multi-centric, Randomized, Double-blind, Parallel, Saline Controlled Phase II Safety and Efficacy Study of PMZ-2010 as a Resuscitative Agent for Hypovolemic Shock to be Used Along With Standard Shock Treatment.
This is a prospective, multi-centric, randomized, double-blind, parallel, controlled phase-II
efficacy clinical study of PMZ-2010 therapy in patients with hypovolemic shock.
Centhaquine is highly safe and well tolerated. Toxicological studies showed high safety
margin in preclinical studies. Its safety and tolerability has been demonstrated in a human
phase I study in 25 subjects (CTRI/2014/06/004647; NCT02408731).
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.
Unlike presently used vasopressors, centhaquine increased mean arterial pressure by
increasing stroke volume and cardiac output, and it decreased systemic vascular resistance.
The most common adverse effects of vasopressors as a class include arrhythmias, fluid
extravasation, and ischemia. Centhaquine does NOT act on beta-adrenergic receptors, and
therefore the risk of arrhythmias is mitigated. It is NOT a vasopressor; however, it
increases blood pressure and cardiac output by augmenting venous blood return to the heart
and enhanced tissue perfusion by arterial dilatation. Enhancing tissue perfusion is a
significant advantage over existing vasopressors.
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