A Study to Assess Safety and Efficacy of Centhaquine as a Resuscitative Agent (NCT05251181) | Clinical Trial Compass
Not Yet RecruitingPhase 3
A Study to Assess Safety and Efficacy of Centhaquine as a Resuscitative Agent
430 participantsStarted 2026-02
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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Inclusion 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 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.
What they're measuring
1
Proportion of subjects with all-cause mortality [Time frame: Day 0 through day 28].