Comparison between adrenaline vs noradrenaline in children with cancer presenting with shock
Phase 3
- Conditions
- Health Condition 1: R031- Nonspecific low blood-pressure reading
- Registration Number
- CTRI/2022/09/045180
- Lead Sponsor
- Apollo Hospitals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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 < 24 hrs (since many are in recalcitrant downward spiral of overall condition where the impact of one or other vasoactive may be difficult to assess).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 <br/ ><br>2.Vasoactive-inotrope score at 6 hours <br/ ><br>3.Days alive and free of organ support (ventilator support, Renal replacement therapy) up to 28-days <br/ ><br>
- Secondary Outcome Measures
Name Time Method 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 <br/ ><br>2.Vasoactive-inotrope score at 6 hours <br/ ><br>3.Days alive and free of organ support (ventilator support, Renal replacement therapy) up to 28-days <br/ ><br>