Trial of non-invasive (applied to body externally) continuous circulation monitoring for the management of severe infection and shock (impaired circulation and fall in blood pressure) in children.
Not Applicable
- Conditions
- Health Condition 1: R652- Severe sepsis
- Registration Number
- CTRI/2019/07/020080
- Lead Sponsor
- Dr Mounika Reddy
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Children aged 2 months to 18 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-arrest cardiac dysfunction and shock
4.Children with severe acute malnutrition
5.Children with chronic kidney disease
6.Moribund patients with anticipated survival < 24 hrs
7.Not willing to participate in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Difference in the fluid volume requirement in the first 6 hours (0-6 hours) between the two groupsTimepoint: Difference in the fluid volume requirement in the first 6 hours (0-6 hours) between the two groups
- Secondary Outcome Measures
Name Time Method MortalityTimepoint: 28 days;oLength of PICU stay and hospital stayTimepoint: length of stay;oOrgan dysfunction scores (pSOFA and PELOD-2) at 24, 48 and 72 hoursTimepoint: 24, 48 and 72 hours;oProportion of children achieving shock resolution at 6, 12, 24, 48 and 72 hours of resuscitation.Timepoint: 6, 12, 24, 48 and 72 hours