Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: Metabolic resuscitation using Hydrocortisone Ascorbic acid and Thiamine in children with septic shock: The trial compares metabolic resuscitation, defined as hydrocortisone, ascorbic ac
Sponsors
All India Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: Illness -Admitted to PICU treated for septic shock (fluid refractory shock) Treatment Received inotropes for at least 2 h Consent Parental/caregiver consent prior to or after enrolment (Definitions of surviving sepsis campaign 2020 will be followed for diagnosis of septic shock)
Exclusion criteria
Exclusion criteria: 1. Age Preterm babies born 2. Treatment - Received inotropes for >24 h pre-enrolment 3. Patient is receiving treatment for a systemic fungal infection or has documented strongyloides infection at the time of randomization 4. Patient undergoing active chemotherapy for cancer treatment 5. Co-morbidities •Fulmonant Myocarditis, Congenital heart disease 6. Chronic hypertension due to cardiovascular or renal disease, requiring regular antihypertensive treatment. 7. Known chronic kidney disease (defined as requiring Renal Replacement Therapy) 8. Known chronic hepatic failure 9. Known diseases affecting the steroid axis, including pituitary disease, congenital adrenal hypoplasia, Cushing or Addison’s a. disease 10. Known glucose-6 phosphate dehydrogenase (G-6PD) deficiency 11. Patients with a known history of oxalate nephropathy 12. Patients with acute beriberi disease 13. Patients with acute Wernike’s encephalopathy 14. Patients with known malaria 15. Patients with known suspected scurvy 16. Palliative care patient/patient with limitation of treatment (not for inotropes, cardiopulmonary resuscitation, extracorporeal membrane oxygenation, intubation, or ventilation) 17. Cardiopulmonary arrest in the past 2 h requiring cardiopulmonary resuscitation of >2min duration, or death is deemed to be imminent or inevitable during this admission. 18. Major bleeding with hemorrhagic shock 19. Sepsis is not likely to be the cause of shock
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the total number of organ failure-free days in the first 28 daysTimepoint: First 28 days from the day of randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Total duration of inotropes received in days. 2.Change in the pSOFA score from time of randomization to 72 hours & at 28 days will be used to calculate organ dysfunction free days 3.Day of admission to discharge 4.Duration of PICU stay 5.Time needed for resolution of acute kidney injury Timepoint: 28 days | — |
Countries
India
Contacts
Public ContactDr Jhuma Sankar
Al India Institute of Medical Sciences
Outcome results
None listed