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Use of noninvasive monitoring along with clinical monitoring for need of fluid bolus in pediatric septic shock

ELECTROCARDIOMETRY FOR MANAGEMENT OF PAEDIATRIC SEPTIC SHOCK-A RANDOMIZED CONTROL TRIAL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/03/041366
Enrollment
120
Registered
2022-03-24
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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: Cardiometry monitoring along with Standard clinical monitoring till resolution of shock: Attachment of Electrocardiometry device(ICON) Control Intervention1: standard clinical monitorin

Sponsors

Suman Sudha Moharana
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 2 months to 18 years with septic shock,defined as children with suspect or confirmed sepsis & unresolved shock/hypoperfusion after initial 10 ml/kg fluid bolus

Exclusion criteria

Exclusion criteria: Children with fulminant Myocarditis Children with unrepaired congenital heart disease Post arrest cardiac dysfunction & shock Children with Severe acute malnutrition Children with chronic kidney disese Moribound patients with anticipated survival Not willing to participate in study Children who received fluid bolus in outside facility

Design outcomes

Primary

MeasureTime frame
To Evaluate the difference in fluid volume requirement in first 6 hours between two groupsTimepoint: 6 hours

Secondary

MeasureTime frame
Proportion of children achieving shock resolution at 6 12 24 48 and 72 hours of resuscitation Vasoactive-inotrope score at 6 12 24 48 and 72 hours Fluid overload percent at 24 48 and 72 hours Organ dysfunction scores pSOFA and PELOD2 and severity of illness score PRISM at 24 48 and 72 hours Need for and duration of mechanical ventilation Need for RRT within 28 days Length of PICU stay and hospital stay Early within 7 days and late 7 to 28 day mortality Timepoint: 6 hour 12 hour 24 hour 72 hour

Countries

India

Contacts

Public ContactSuman Sudha Moharana

St. John,s Medical College

drlalitha03@gmail.com9448461673

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026