In critically ill severely malnourished children with septic shock, to test efficacy of current WHO protocol inotrope Dopamine with pediatric protocol inotrope Adrenaline
Phase 3
- Conditions
- Health Condition 1: R652- Severe sepsis
- Registration Number
- CTRI/2023/09/057776
- Lead Sponsor
- Priyadarshini M
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
SAM children of 1 to 59 months of age associated with Fluid refractory septic shock
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare effect of Dopamine/ Adrenaline with respect to – <br/ ><br> 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 <br/ ><br>Timepoint: for shock resolution - baseline(0hr),2hr, 6hr, 12hr, 24hr <br/ ><br>Outcome for survival/mortality- baseline at admission, Either day 2 or day 3.
- Secondary Outcome Measures
Name Time Method Disease severity score , Multi Organ Dysfunction Score <br/ ><br>PRISM III, PELOD 2 <br/ ><br>Timepoint: Baseline at admission, either Day 2 or day 3 to predict outcome