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 yet recruiting

Conditions: Severe sepsis,

Registration Number: CTRI/2019/07/020080

Lead Sponsor: Dr Mounika Reddy

Brief Summary: Accuratehemodynamic assessments are necessary to guide therapy (including fluids,vasoactives, inotropes) in pediatric septic shock. Traditional clinical monitoringis not accurate enough for hemodynamic categorization to guide management.Invasive cardiac output monitoring with pulmonary artery catheter (PAC) is thegold standard, however it is associated with risks. Continuous monitoringallowing for real-time therapy guidance helps in optimizing fluidadministration and/or drug titrations for time-sensitive, goal directedresuscitation which improves outcomes in pediatric septic shock.Electrocardiometry has been validated for non-invasive continuous hemodynamicmonitoring in children and adults. However, whether it will provide betterguidance regarding management of pediatric septic shock compared to standardcare clinical monitoring alone is not known, and whether this translates intobetter important patient centred outcomes like reduced mortality and morbidityis not known, hence the need for this study.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 120

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 groups	Difference in the fluid volume requirement in the first 6 hours (0-6 hours) between the two groups

Secondary Outcome Measures

Name	Time	Method
Mortality	28 days
oOrgan dysfunction scores (pSOFA and PELOD-2) at 24, 48 and 72 hours	24, 48 and 72 hours
oLength of PICU stay and hospital stay	length of stay
oProportion of children achieving shock resolution at 6, 12, 24, 48 and 72 hours of resuscitation.	6, 12, 24, 48 and 72 hours

Trial Locations

Locations (1): St. Johns Medical College Hospital
🇮🇳
Bangalore, KARNATAKA, India
St. Johns Medical College Hospital
🇮🇳Bangalore, KARNATAKA, India
Dr Mounika Reddy
Principal investigator
08022065000
doc.mounikareddy@gmail.com