Health Condition 1: T304- Corrosion of unspecified body region, unspecified degree
Conditions
Interventions
Intervention1: ULINASTATIN: Route: Intravenous infusion
Dose: 2000 IU over 1 hour infusion once daily for three consecutive days. All patients received Ulinastatin 5ml/kg once daily for three days
C
Sponsors
None
Eligibility
Inclusion criteria
Inclusion criteria: 1. suspected or confirmed infection as evidenced by the ordering of blood cultures and the administration of at least one antimicrobial agent 2. anticipated or confirmed ICU admission 3. acute respiratory or cardiovascular organ dysfunction (or both) attributed to sepsis characterized by at least one of the following at the time of randomization: respiratory support requirement: acute hypoxemic respiratory failure defined as persistent hypoxemia, partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2) of not more than 300 or blood oxygen saturation/FiO2 (SpO2/FiO2) of not more than 315 requiring (1) intubation and mechanical ventilation, (2) non-invasive positive pressure ventilation (NIPPV) via a tight-fitting face mask, or (3) high-flow nasal cannula of at least 40L per minute with an FiO2 of at least 0.40, vasopressor requirement: a continuous infusion of norepinephrine, epinephrine, vasopressin, dopamine, phenylephrine, or other vasopressor agent at any dose for more than 1 h and required to maintain a mean arterial pressure of at least 65mm Hg despite intravenous crystalloid resuscitation of at least 1000mL.
Exclusion criteria
Exclusion criteria: 1. Age of less than 18 years 2. qualifying organ dysfunction no longer present at the time a subject would be randomly assigned (i.e., does not require either (1) respiratory support as defined above to maintain PaO2/FiO2 of more than 300 or SpO2/FiO2 of more than 315 or(2) Vasopressor infusion to maintain a mean arterial pressure of at least 65 mm Hg) 3. Cardiovascular or respiratory organ failure caused by an illness other than sepsis 4. First episode of qualifying organ dysfunction during a given ICU admission occurred more than 24 h before subject could be randomly assigned 5. Limitations of care (defined as refusal of cardiovascular and respiratory support modes described in inclusion criteria), including do not intubate status 6. Current hospitalization of more than 30 days at the time. 7. Chronic hypoxemia requiring supplemental non-invasive oxygen via nasal cannula or NIPPV (i.e., continuous positive airway pressure and bi-level positive airway pressure) or home mechanical ventilation 8. chronic cardiovascular failure requiring home mechanical hemodynamic support (e.g., ventricular assist device) or home chemical hemodynamic support (e.g., Milrinone) 9. Known allergy or known contraindication to vitamin C or pantaglobin 10. Chronic disease/illness that, in the opinion of the site investigator, has an expected life span of less than 30 days unrelated to current sepsis diagnosis (e.g., stage IV malignancy and neurodegenerative disease) 11. Pregnancy or known active breastfeeding 12. Prisoner or incarceratio 13. Inability or unwillingness of subject or legal surrogate/representative to give written informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Length of Hospital stay Length if stay in ICU Timepoint: at discharge | — |
Secondary
| Measure | Time frame |
|---|---|
| Use of Colloid and FFP during hospital stayTimepoint: at discharge;S. procalcitonin, CRP, IL6 and Lactate levelsTimepoint: 24,48,72,96 hrs after intervention drug | — |
Countries
India
Contacts
Public ContactDr Ajay Chaudhary
King Georges Medical University
Outcome results
None listed