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Comparison of two commonly used vasoactive agents in children with septic shock

Phase 4
Completed
Conditions
Health Condition 1: I958- Other hypotension
Registration Number
CTRI/2019/05/019078
Lead Sponsor
All India Institute of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
67
Inclusion Criteria

Children aged 2 months to 17 years with early septic shock, defined as children with suspect or confirmed sepsis and unresolved shock/hypoperfusion after the initial 20ml/kg fluid bolus.

Exclusion Criteria

1.Children with fulminant myocarditis

2.Children with unrepaired congenital heart disease

3.Post-operative sepsis/septic shock within 72 hours of bypass surgery.

4.Children with Severe Acute Malnutrition

5.Children with chronic kidney disease.

6.Parents not willing to participate in the study

7.Caregiver/Physician unwilling for patient to be enrolled

8.Post-arrest shock and cardiac dysfunction

9.Moribund patients in whom anticipated survival < 24 hrs (since many are in 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
NameTimeMethod
Fluid volume in ml/kg required in first 6 hours of beginning vasoactive agentsTimepoint: At 6 hours of enrollment
Secondary Outcome Measures
NameTimeMethod
MoratlityTimepoint: Measured till 28 days from the time of admission. <br/ ><br>Measured at 28 days or earlier if death occurs.;Organ dysfunction scoresTimepoint: At 24, 48 and 72 hours;Proportion of children achieving shock resolutionTimepoint: Measured at 6,12, 24, 48 and 72 hours of resuscitation
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