Health Condition 1: R652- Severe sepsis
Conditions
Interventions
Intervention1: Hydrocortisone and Vitamin C: Hydrocortisone 1mg/kg 6 hourly with Vitamin C 100mg/kg 6 hourly for upto 72 hours
Control Intervention1: Hydrocortisone only: Hydrocortisone 1mg/kg 6 hourl
Sponsors
George Institute for Global Health India
Eligibility
Inclusion criteria
Inclusion criteria: 1. Admitted to PICU 2. Decision by treating physician to treat as sepsis (including parenteral antibiotics and inortopes) 3. Treatment of septic shock with vasopressor/inotrope for >1 hour, or Vasopressor-Inotrope Score of atleast 10
Exclusion criteria
Exclusion criteria: 1. Preterm babies born 2. Palliative care patient/patient with limitation of treatment (not for Inotropes, CPR, ECLS, Intubation and Ventilation) 3. Cardiopulmonary arrest in the past 2 hours requiring CPR for >2 minutes, or death is deemed to be imminent or inevitable 4. Patients with sepsis/shock who have been treated with inotropes for >24 hours 5. Patients with known glucose-6-phosphate (G6PD)dehydrogenase deficiency 6. Patients with known history of oxale nephropathy 7. Patients with known malaria 8. Patients already receiving cyanocobalamin or Deferoxamine for their co-morbid conditions 9. Enrolment in the RESPOND study in the past 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time alive and free of vaspressorsTimepoint: Censored at 7 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Alive and free of multi-organ dysfunctionTimepoint: 72 hours;Hospital length of stayTimepoint: N/A;MortalityTimepoint: N/A;Quality of lifeTimepoint: 28 days and 6 months;Survival free of cardiovascular supportTimepoint: N/A;Survival free of organ supportTimepoint: N/A;Survival free of ventilationTimepoint: N/A | — |
Countries
Australia, Brazil, Democratic People's Republic of Korea, India
Contacts
Public ContactVivekanand Jha
George Institute for Global Health
Outcome results
None listed