Health Condition 1: T794- Traumatic shock
Conditions
Interventions
Intervention1: Lyfaquin (Lyophilized Centhaquin citrate Injection) 1.0 mg/vial: Lyfaquin (Dose: 0.01 mg/kg) + Standard of care: Lyfaquin will be administered intravenously after enrolment in study to
Sponsors
Pharmazz India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult males or females aged 18 years or older. 2. Patients with hypovolemic shock admitted to the emergency room or ICU with systolic blood pressure = 90 mmHg at presentation and continue to receive standard shock treatment (endotracheal intubation; fluid resuscitation and vasopressors). Standard of care to be provided to the patients shall be the one used in each hospital setup. 3. Blood Lactate level indicative of hypovolemic shock with lactate level more than 2 mmol/L.
Exclusion criteria
Exclusion criteria: 1. Development of any other terminal illness not associated with hypovolemic shock during study duration. 2. Patient with altered consciousness not due to hypovolemic shock and comatose patient. 3. Known pregnancy. 4. Cardiopulmonary resuscitation (CPR) before enrollment. 5. Presence of a do not resuscitate order. 6. Patient is participating in another interventional study. 7. Patients with systemic diseases which were already present before having trauma, such as: sepsis, cancer, chronic renal failure, liver failure, decompensated heart failure or AIDS. Decision to be made by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with adverse events (AEs) and serious adverse events (SAEs)Timepoint: Each patient will be monitored closely throughout his/her hospitalization and will be followed until discharge or day 7 (whichever is earlier) from enrollment | — |
Secondary
| Measure | Time frame |
|---|---|
| Systolic and diastolic blood pressure; Mean through 48 hours and at the time of discharge or day 7.Timepoint: first 48 hours and at the time of discharge or day 7;Base-deficit; Mean through 48 hoursTimepoint: first 48 hours;Time in intensive care unit (ICU)Timepoint: At the time of discharge or day 7;Time on ventilatorTimepoint: at the time of discharge or day 7;Change in blood lactate, Mean through 48 hoursTimepoint: first 48 hours;Urine output during the first 48 hoursTimepoint: first 48 hours;Incidence of mortalityTimepoint: at the time of discharge or day;Multiple Organ Dysfunction Syndrome score (MODS); Mean through day 7 or at the time of dischargeTimepoint: At the time of discharge or day 7;Acute Respiratory Distress Syndrome (ARDS); Mean through day 7 or at the time of dischargeTimepoint: At the time of discharge or day 7;Glasgow Coma Scale (GCS); Mean through day 7 or at the time of dischargeTimepoint: At the time of discharge or day 7 | — |
Countries
India
Contacts
Public ContactMr Sunil Gulati
Pharmazz India Pvt. Ltd.
Outcome results
None listed