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In critically ill severely malnourished children with septic shock, to test efficacy of current WHO protocol inotrope Dopamine with pediatric protocol inotrope Adrenaline

Dopamine Versus Adrenaline As The Initial Inotrope in Septic Shock In Children With Severe Acute Malnutrition Randomised Controlled Study - NIL

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/09/057776
Enrollment
220
Registered
2023-09-18
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

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: Adrenaline: given intravenously either peripheral or central venous access, continuously through infusion pump for the initial 24 hours from admission, with dose range of 0.1 to 0.5mg/k

Sponsors

Priyadarshini M
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: SAM children of 1 to 59 months of age associated with Fluid refractory septic shock

Exclusion criteria

Exclusion criteria: Children who received inotropes outside for shock management, Children who had resuscitation at time of admission, Major congenital malformation, Inborn errors of metabolism, known congenital heart disease

Design outcomes

Primary

MeasureTime frame
To compare effect of Dopamine/ Adrenaline with respect to – Time of resolution of fluid refractory septic shock assessed at baseline,2hr,6hr,12hr,24hr. Whether dopamine or adrenaline decrease the mortality at admission as baseline and on either Day 2 or 3 to predict outcome Timepoint: for shock resolution - baseline(0hr),2hr, 6hr, 12hr, 24hr Outcome for survival/mortality- baseline at admission, Either day 2 or day 3.

Secondary

MeasureTime frame
Disease severity score , Multi Organ Dysfunction Score PRISM III, PELOD 2 Timepoint: Baseline at admission, either Day 2 or day 3 to predict outcome

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