A Study to Assess Safety and Efficacy of Centhaquine as a Resuscitative Agent
ConditionHypovolemic Shock
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorPharmazz, Inc.
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Normal Saline
DrugNormal Saline to be Used as Vehicle in the Phase-III Study to Assess Efficacy of Centhaquine as a Resuscitative Agent for Hypovolemic Shock
Centhaquine
DrugPhase-III Study to Assess Efficacy of Centhaquine as a Resuscitative Agent for Hypovolemic Shock
Treatment groups
430 Participants
are divided into 2 treatment groupsGroup A: Normal salineActive comparator 1 intervention
Group B: CenthaquineExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of subjects with all-cause mortality [Time frame: Day 0 through day 28].
Incidence of mortality
Time frame
Day 0 through day 28Secondary outcomes
1
Proportion of subjects with all-cause mortality within 48 hours
Proportion of subjects with all-cause mortality within 48 hours
Time frame
48 hours2
Change in Mean Arterial Pressure (MAP) from baseline of at least 10 mm Hg; Mean through 48 hours and at the time of discharge or day 7
Change in Mean Arterial Pressure (MAP) from baseline of at least 10 mm Hg; Mean through 48 hours and at the time of discharge or day 7
Time frame
First 48 hours and at the time of discharge or day 73
Time (hours) to decrease blood lactate level to <2 mmol/L
Time (hours) to decrease blood lactate level to \<2 mmol/L; Mean through 2 hours for the first 12 hours, then every 6 hours for the next 36 hours.
Time frame
48 hours4
Proportion of patients with adverse events (AEs) and serious adverse events (SAEs)
Proportion of patients with adverse events (AEs) and serious adverse events (SAEs)
Time frame
Day 0 through day 28Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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