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MITOCHONDRIAL SUPPLEMENTATION IMPACT ON RESOLUTION OF PEDIATRIC SEPTIC SHOCK

IMPACT OF MITOCHONDRIAL SUPPLEMENTATION ON RESOLUTION OF PEDIATRIC SEPTIC SHOCK: A PROSPECTIVE RANDOMIZED CONTROL TRIAL - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/095126
Enrollment
160
Registered
2025-09-19
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Health Condition 1: R652- Severe sepsis

Interventions

Intervention1: Mitochondrial Supplementation: Thiamin Vitamin C Vitamin E Carnitine Coenzyme Q Hydrocortisone Control Intervention1: NIL: NIL

Sponsors

AIIMS RISHIKESH
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 1 months to 18 years with septic shock, defined as children with suspect or confirmed sepsis and cardiovascular dysfunction as per Phoenix Sepsis Score

Exclusion criteria

Exclusion criteria: Children who require Nil per oral status Children with known HIV/HbSAg/HCV positive status Children with confirmed Immunodeficiency Children with malignancy Children who are known cases of G6PD deficiency/ Oxalate nephropathy

Design outcomes

Primary

MeasureTime frame
Comparison on median VIS score (Vasoactive inotrope score) during 1st 3 days after initiation of therapy.Timepoint: Comparison on median VIS score (Vasoactive inotrope score) during 1st 3 days after initiation of therapy.

Secondary

MeasureTime frame
Survival status at Day 3, Day 7, and Day 28 following initiation of mitochondrial supplementation in pediatric patients with septic shock. Maximum vasoactive-inotropic score (VIS) on Days 5 and 7 Trend in Pediatric Sequential Organ Failure Assessment (pSOFA) scores from admission through Day 7 or until PICU discharge, whichever occurs earlier. Ventilation-free days and Inotrope-free days within the first 28 days.Timepoint: 3, 7, 28 DAYS

Countries

India

Contacts

Public ContactSrijan Sinha

AIIMS RISHIKESH

LOKESHDOC@YAHOO.COM9631638095

Outcome results

None listed

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