Health Condition 1: R652- Severe sepsis
Conditions
Interventions
Intervention1: Vitamin C , Thiamine and Hydrocortisone: Supplementation with Vitamin C (1.5gm), Thiamine(100 mg) and Hydrocortisone (50mg) every 6 hours for 4 days + Specific treatment -Standard of c
Sponsors
Dasari Sai Divya
Eligibility
Inclusion criteria
Inclusion criteria: (1) Patients in septic shock with vasopressor requirement : a continuous infusion of epinephrine, vasopressin, nor epinephrine, dopamine or other vasopressor agent at any dose required to maintain a mean arterial pressure of at least 65 mm hg despite intravenous crystalloid resuscitation of at least 30 ml/kg (2) Suspected or confirmed infection as evidenced by the ordering of blood and urine cultures and the administration of at least one antimicrobial agent (3) Patients who are candidates for ICU admission
Exclusion criteria
Exclusion criteria: (1) Shock due to other causes (2) Limitations of care (defined as refusal of cardiovascular and respiratory support modes) including "do not intubate" status (3) known allergy or known contraindication to Vitamin C , Thiamine , or corticosteroids (4) Chronic illness / disease that, in opinion of the site investigator , has an expected life span of less than 30 days unrelated to current sepsis diagnosis ( example: stage IV malignancy and neurodegenerative disease ) (5) Pregnancy or known active breast feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (1) Vasopressor and ventilator free days (VVFD) (2) SOFA score (3) New onset AKI resolutionTimepoint: (1) Vasopressor and ventilator free days (VVFD) at baseline, at 3 days, at 1 week, at 2 weeks, at 4 weeks. (2) SOFA score - initial assessment and at baseline, at 3 days, at 1 week, at 2 weeks, at 4 weeks. (3) New onset AKI resolution at baseline, at 3 days, at 1 week, at 2 weeks, at 4 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Over all mortalityTimepoint: Over all mortality at baseline, at 3 days, at 1 week, at 2 weeks & at 4 weeks. | — |
Countries
India
Contacts
Public ContactDr Bhargav Kiran Gaddam
Mahatma Gandhi Medical College and Research Institute
Outcome results
None listed