Efficacy of PMZ-2010 (Centhaquine) a Resuscitative Agent for Hypovolemic Shock

• Status: Completed
• Trial end date: 2019-09-27
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pharmazz, Inc.

Criteria

Inclusion Criteria:

• 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. Blood Lactate level indicative of hypovolemic shock (>2.0 mmol/L).

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.