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Comparison between adrenaline vs noradrenaline in children with cancer presenting with shock

Efficacy of Epinephrine versus Nor-epinephrine as the initial vasoactive agent in Paediatric hematoncology patients with shock- A Feasibility Pilot study - NEO study

Status
Recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/09/045180
Enrollment
100
Registered
2022-09-02
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-18

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

Conditions

Health Condition 1: R031- Nonspecific low blood-pressure reading

Interventions

Intervention1: Start of study drug for shock: After adequate fluid resuscitation either of the two drugs are started and clinical status assessed Control Intervention1: Norepinephrine: Pressor agent i

Sponsors

Apollo Hospitals
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Hematoncology patients aged 1 month to 17 years with early shock, defined as children with unresolved shock/hypoperfusion after the initial 10- 20ml/kg fluid bolus.

Exclusion criteria

Exclusion criteria: 1. Children with fulminant myocarditis 2. Children with established, untreated heart disease 3. Parents not willing to participate in the study 4. Caregiver/Physician unwilling for patient to be enrolled 5. Post-arrest shock 6. Moribund patients in whom anticipated survival

Design outcomes

Primary

MeasureTime frame
Pilot study to assess feasibility for randomized control trial enrolment, adherence to trial protocol and follow up with respect to resolution of shock in hematoncology patients aged 1 month to 17 years with early undifferentiated shock.Timepoint: 1.Fluid requirement in 0-6 hours and 6-24 hours 2.Vasoactive-inotrope score at 6 hours 3.Days alive and free of organ support (ventilator support, Renal replacement therapy) up to 28-days

Secondary

MeasureTime frame
To determine the choice of first vasoactive agent between epinephrine and norepinephrine in pediatric hematoncology patients with undifferentiated shockTimepoint: 1. Fluid requirement in 0-6 hours and 6-24 hours 2. Vasoactive-inotrope score at 6 hours 3. Days alive and free of organ support (ventilator support, Renal replacement therapy) up to 28-days

Countries

India

Contacts

Public ContactDr Ananya Sampath

Apollo Hospitals, Chennai

indirajayakumar@yahoo.com09710925667

Outcome results

None listed

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