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Clinical Trials/CTRI/2023/09/057494
CTRI/2023/09/057494
Not yet recruiting
Phase 3

Resuscitation in Paediatric Sepsis using Hydrocortisone and Vitamin C - A Randomized Controlled Multicentre Trial - RESPOND

George Institute for Global Health India0 sites0 target enrollmentTBD
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Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Not specified
Sponsor
George Institute for Global Health India
Status
Not yet recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
George Institute for Global Health India

Eligibility 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

  • •1\. Preterm babies born \<34 weeks gestation that have a corrected age of \<7 days
  • •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

Outcomes

Primary Outcomes

Not specified

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