Status:
NOT_YET_RECRUITING
A Study to Assess Safety and Efficacy of Centhaquine as a Resuscitative Agent
Lead Sponsor:
Pharmazz, Inc.
Conditions:
Hypovolemic Shock
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Detailed Description
Despite advances in medical science, treatments for hypovolemic shock have changed little in the past 30-40 years. A wounded soldier bleeding on the battlefield, or a trauma victim, is treated today l...
Eligibility Criteria
Inclusion
- A subject will be eligible for inclusion in the study if he/she fulfils the following criteria:
- Adult males or females aged 18 years or older.
- 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.
- Blood lactate level indicative of hypovolemic shock with lactate level more than 2 mmol/L.
Exclusion
- A subject will not be eligible for inclusion in this study if he/she meets any of the following exclusion criteria:
- Subject with illness clinically defined as septic shock (Procalcitonin plasma levels of ≥0.5 ng/mL) or cardiogenic shock or neurogenic shock.
- Subject for whom an etiology for hypovolemic shock cannot be determined on initial evaluation.
- Hypovolemic shock due to traumatic brain injury, traumatic tamponade, traumatic tension pneumothorax, ventricular wall rupture.
- Patient with altered consciousness not due to hypovolemic shock.
- Subject with confirmed pregnancy.
- Cardiopulmonary resuscitation (CPR) before randomization.
- Presence of a do not resuscitate order.
- Patient is participating in another interventional study.
- Patients with systemic diseases which were already present before having trauma, such as: cancer, chronic renal failure, liver failure, decompensated heart failure or AIDS.
Key Trial Info
Start Date :
February 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
430 Patients enrolled
Trial Details
Trial ID
NCT05251181
Start Date
February 1 2026
End Date
October 1 2027
Last Update
December 30 2025
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