Health Condition 1: I958- Other hypotension
Conditions
Interventions
Intervention1: Centhaquine: Centhaquine (Dose: 0.003 mg/kg x 3 doses per day) + Standard
of care. Patients will be treated for a total of 24 hours. 3 doses of 0.003mg/kg centhaquine at 4 hours of int
Sponsors
Aman Hospital and Research Centre
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP)Timepoint: Time frame: 24 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Stroke Volume (SV)Timepoint: Before and 1h after each IP administration.;Change in cardiac output (CO)Timepoint: Before and 1h after each IP administration.;Proportion of patients with an increase in Mean Arterial Pressure (MAP) from baseline of at least 10 mmHgTimepoint: Time frame: 24 hours;Change in Mean Arterial Pressure (MAP)Timepoint: Mean through 24 hours;Change in Heart Rate (HR)Timepoint: Mean through 24 hours;Change in blood lactateTimepoint: Mean through 24 hours;Amount of fluid (crystalloids and colloids) infusedTimepoint: Mean through 24 hours;Amounts of vasopressor(s) infusedTimepoint: Mean through 24 hours;Total Urine outputTimepoint: Time frame: 24 Hours];Proportion of patients with adverse events (AEs) and serious adverse events (SAEs)Timepoint: Through out study period | — |
Countries
India
Contacts
Public ContactDrAman Khanna
Aman Hospital and Research Centre
Outcome results
None listed