A Study to Assess the Safety and Efficacy of Centhaquine in Hypovolemic Shock Patients
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This is a prospective, multi-centric, open-labeled, phase-IV clinical study to evaluate the safety and efficacy of centhaquine citrate (LYFAQUIN™), a first-in-class drug for treating hypovolemic shock, a life-threatening condition caused by severe blood or fluid loss. Centhaquine has been found to be an effective resuscitative agent in rat, rabbit, and swine models of hemorrhagic shock. It has demonstrated the ability to decrease blood lactate levels, increase mean arterial pressure, enhance cardiac output, and reduce mortality rates. The increase in cardiac output during resuscitation is primarily attributed to an augmentation in stroke volume. Centhaquine exerts its effects by acting on the venous α2B-adrenergic receptors, which enhances venous return to the heart. Additionally, it produces arterial dilation by targeting central α2A-adrenergic receptors, thereby reducing sympathetic activity and systemic vascular resistance.
Eligibility Criteria
Inclusion Criteria • Adult hypovolemic shock patients aged 18 years or older 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 * Development of any other terminal illness not associated with hypovolemic shock during the study duration. * Patient with altered consciousness not due to hypovolemic shock and comatose patient. • Known pregnancy. * Cardiopulmonary resuscitation (CPR) before enrollment. * 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 sepsis, cancer, chronic renal failure, liver failure, decompensated heart failure, or AIDS.