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: Role of Pantoprazole as a stress ulcer prophylaxis in pediatric critically ill population

: Role of Proton pump inhibitor as Stress Ulcer Prophylaxis in critically ill children: A single-center blinded randomized controlled trial - SUPCRIT

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/08/035785
Enrollment
610
Registered
2021-08-18
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: INJ. PANTOPRAZOLE: Patients in the study arm will receive Early Enteral Nutrition ( within 24 hours of PICU admission) with Inj. Pantoprazole 1 mg/kg diluted in Normal saline once a day

Sponsors

Dr ANANYA KAVILAPURAPU
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Shock/hemodynamic instability - Invasive or non-invasive mechanical ventilation expected to last > 24 hours - Coagulopathy (platelet 1.5 or prothrombin time (PT) > 20 s or APTT > 50s) - Treatment with anticoagulant drugs - Chronic liver disease (portal hypertension, cirrhosis, variceal bleeding or hepatic encephalopathy)

Exclusion criteria

Exclusion criteria: - Contraindications to PPIs (including intolerance of PPIs) - Current daily treatment with a PPI and/or a H2RA - GI bleeding of any origin during current hospital admission - Burn injury - Chronic steroid therapy - Closed head injury or increased intracranial pressure - History of partial or complete gastrectomy - Known peptic ulcer disease - Not willing to participate in the study - Moribund patients with anticipated survival

Design outcomes

Primary

MeasureTime frame
Clinically Significant Gastrointestinal BleedingTimepoint: Reaching full Enteral Nutrition Discharge from PICU 28 days of PICU stay Death

Secondary

MeasureTime frame
1. 28-day all-cause mortality 2. Length of PICU and hospital stay 3. Duration of mechanical ventilation 4. Incidence of Ventilator Associated/nosocomial Pneumonia 5. Incidence of Clostridium difficile infection 6. Incidence of serious adverse events 7. Organ dysfunction scores (PELOD, SOFA) Timepoint: Reaching full Enteral Nutrition Discharge from PICU 28 days of PICU stay Death

Countries

India

Contacts

Public ContactDr ANANYA KAVILAPURAPU

st. Johns medical College and Hospital

drlalitha03@gmail.com9886792648

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 5, 2026