CTRI/2023/11/059609
Not yet recruiting
Phase 3
Metabolic Resuscitation in Pediatric Septic Shock Using HAT (Hydrocortisone, Ascorbic acid and Thiamine) Therapy an Open Label Randomized Controlled Trial
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: O- Medical and Surgical
- Sponsor
- All India Institute of Medical Sciences
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •1\.Age Preterm babies born \<34 weeks gestation that have a corrected age of \<28 days
- •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
- •10\.Known glucose\-6 phosphate dehydrogenase (G\-6PD) deficiency
Outcomes
Primary Outcomes
Not specified
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