A Study to Assess Safety and Efficacy of Centhaquine as a Resuscitative Agent
Hypovolemic Shock
About this trial
This is an interventional treatment trial for Hypovolemic Shock
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Normal saline
Centhaquine
Hypovolemic shock patients will be provided the standard of care. Following randomization 100 ml (equal volume to experimental arm) of normal saline will be administered intravenously over 1 hour.
Hypovolemic shock patients will be provided the standard of care. Following randomization centhaquine (0.01 mg/kg) will be administered intravenously over 1 hour in 100 mL of normal saline.