A Prospective, Multi-centric, Open-labeled, Phase-IV Study to Assess Safety and Efficacy of LYFAQUIN173 (Centhaquine Citrate) as a Resuscitative Agent for Hypovolemic Shock to be Used as an Adjuvant to Standard Treatment of Shock

What this Trial Is About

Researchers are evaluating the safety and efficacy of centhaquine citrate (LYFAQUIN173), a new drug for treating hypovolemic shock, a serious condition caused by severe blood or fluid loss. This phase IV, prospective, multi-center, open-label study builds on previous findings that centhaquine can improve blood pressure, reduce blood lactate levels, increase cardiac output, and reduce death rates by acting on specific adrenergic receptors to improve blood flow. Participants with hypovolemic shock aged 18 years or older and a systolic blood pressure of 90 mmHg or lower at hospital admission will receive centhaquine in addition to standard shock care. Centhaquine is given intravenously at a dose of 0.01 mg/kg body weight over one hour in saline. A second dose may be given if blood pressure remains low, with a maximum of three doses in 24 hours, and treatment can continue for up to two days after enrollment. During hospitalization, participants will be closely monitored and followed until discharge or seven days after enrollment. Researchers will measure safety by tracking adverse events and serious adverse events up to seven days. They will also assess blood pressure, blood lactate, base deficit, time in intensive care, ventilator use, urine output, mortality rates, and organ function scores. Statistical analyses will compare patient outcomes to evaluate centhaquine's effects.

A Study to Assess the Safety and Efficacy of Centhaquine in Hypovolemic Shock Patients