Effect of centhaquine on cardiovascular parameters in patients with hypovolemic shock.

Phase 2

Recruitment & Eligibility

Inclusion Criteria

• Adult males or females aged 18 years or older.

• Subjects with hypovolemic shock admitted to the hospital with systolic

blood pressure = 90 mmHg at presentation and continue to receive

standard treatment of shock (endotracheal intubation; fluid resuscitation,

and vasopressors). The best available standard of care to be provided to the

subject.

• Blood lactate level indicative of hypovolemic shock with lactate level more

than 2 mmol/L.

• Informed consent provided by the patient or legally authorised

representative of the patient

Exclusion Criteria

1. Subject with illness clinically defined as septic shock (confirmed or

suspected acute infection), cardiogenic shock, neurogenic shock.

2.Subject for whom an etiology for hypovolemic shock cannot be determined

on initial evaluation.

3. Hypovolemic shock due to traumatic brain injury including any significant

CNS injury, traumatic tamponade, traumatic tension pneumothorax, ventricular wall rupture.

4. Patient with altered consciousness not due to hypovolemic shock.

5. Subject with confirmed pregnancy.

6. Cardiopulmonary resuscitation (CPR) before randomization.

7. Presence of a do not resuscitate order.

8. Patient is participating in another interventional study.

9. Patients with a history of systemic disease (chronic renal failure, liver failure, decompensated heart failure) or any terminal illness.

Primary Outcome Measures

Name	Time	Method
Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP)Timepoint: Time frame: 24 hours

Secondary Outcome Measures

Name	Time	Method
Change in Mean Arterial Pressure (MAP)Timepoint: Mean through 24 hours;Proportion of patients with an increase in Mean Arterial Pressure (MAP) <br/ ><br>from baseline of at least 10 mmHgTimepoint: Time frame: 24 hours;Total Urine outputTimepoint: Time frame: 24 Hours];Amount of fluid (crystalloids and colloids) infusedTimepoint: Mean through 24 hours;Amounts of vasopressor(s) infusedTimepoint: Mean through 24 hours;Change in blood lactateTimepoint: Mean through 24 hours;Change in cardiac output (CO)Timepoint: Before and 1h after each IP <br/ ><br>administration.;Change in Heart Rate (HR)Timepoint: Mean through 24 hours;Change in Stroke Volume (SV)Timepoint: Before and 1h after each IP <br/ ><br>administration.;Proportion of patients with adverse events (AEs) and serious adverse events (SAEs)Timepoint: Through out study period