A Phase-III Study to Assess Safety and Efficacy of Centhaquine as a Resuscitative Agent

• Status: Not yet recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This protocol is designed to develop a novel first-in-class treatment for use in critical care and life-threatening condition of hypovolemic shock with unmet need and is of national interest. Shock is a life-threatening condition of circulatory failure. It is a state of cellular and tissue hypoxia due to reduced oxygen delivery and/or increased oxygen consumption or inadequate oxygen utilization. Shock most commonly occurs when there is circulatory failure leading to reduced tissue perfusion. There are four types of shock: distributive, cardiogenic, hypovolemic, and obstructive. However, these are not exclusive, and many patients with circulatory failure have a combination of more than one form of shock (multifactorial shock).

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

Details

• Lead Sponsor: Pharmazz, Inc.

Criteria

Inclusion Criteria:

A subject will be eligible for inclusion in the study if he/she fulfils the following criteria:

1. Adult males or females aged 18 years or older.

2. Subjects with hypovolemic shock admitted to the hospital with systolic blood pressure ≤ 90 mm Hg at presentation, Mean Arterial Pressor (MAP) ≤ 65 mm Hg and continue to receive standard treatment of shock (endotracheal intubation; fluid resuscitation and vasopressors). Standard of care to be provided to the subject shall be the one used in that hospital.

3. Blood lactate level indicative of hypovolemic shock with lactate level more than 2 mmol/L.

Exclusion Criteria:

A subject will not be eligible for inclusion in this study if he/she meets any of the following exclusion criteria:

1. Subject with illness clinically defined as septic shock (Procalcitonin plasma levels of ≥0.5 ng/mL) or cardiogenic shock or neurogenic shock.

2. Subject for whom an etiology for hypovolemic shock cannot be determined on initial evaluation.

3. Hypovolemic shock due to traumatic brain injury, traumatic tamponade, traumatic tension pneumothorax, ventricular wall rupture.

4. Patient with altered consciousness not due to hypovolemic shock.

5. Subject with confirmed pregnancy.

6. Cardiopulmonary resuscitation (CPR) before randomization.

7. Presence of a do not resuscitate order.

8. Patient is participating in another interventional study.

9. Patients with systemic diseases which were already present before having trauma, such as: cancer, chronic renal failure, liver failure, decompensated heart failure or AIDS.