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To study ,if giving a combination therapy with injection Hydrocortisone, Ascorbic acid and Thiamine can help in decreasing the severity or early recovery of children diagnosed with sepsis

Adjunctive Hydrocortisone,Ascorbic Acid And Thiamine (HAT) Therapy With Standard Care In The Outcome Of Pediatric Sepsis - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/10/058991
Enrollment
150
Registered
2023-10-20
Start date
Unknown
Completion date
Unknown
Last updated
2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: A419- Sepsis, unspecified organism

Interventions

Intervention1: Effect of Hydrocortisone,Ascorbic Acid And Thiamine in the outcome of pediatric sepsis: Hydrocortisone,Ascorbic Acid And Thiamine is administered as adjunctive therapy along with standa

Sponsors

Aswathy V Nair
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Any patient of the selected age group not belonging to the exclusion criteria with symptoms and signs suggestive of infection .

Exclusion criteria

Exclusion criteria: Shock due to causes other than sepsis,Cardiopulmonary arrest in past 2 hrs of presentation requirind CPR,Severe Acute Malnutrition,Chronic Hepatic or Renal Failure,Condenital or Acquired Heart Diseases,,Metabolic Disorders, Disorders affecting steroid axis,Long term Chemotherapy or steroid therapy,Major Hematological disorders

Design outcomes

Primary

MeasureTime frame
To compare the additional benifit of administering HAT therapy over standard therapy alone in terms of Survival free of organ dysfunction assessed in terms of pSOFATimepoint: At baseline, Day 3 and Day 7 of admission or at discharge from PICU

Secondary

MeasureTime frame
survival free of inotropic support,survival free of PICU,survival free of AKI,Length of stay in PICU,Length of Hospital stay, 28 day mortality,Functional Status ScoreTimepoint: at 7 days and 28 days olf admission

Countries

India

Contacts

Public ContactDr Karan Joshi

Shyam Shah Medical College

drkaranjoshi65@gmail.com9425184975

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026