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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.

Non-invasive continuous hemodynamic monitoring (Electrocardiometry) for the management of paediatric septic shock - A randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/07/020080
Enrollment
120
Registered
2019-07-08
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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: Non-invasive continuous hemodynamic monitoring (electrocardiometry): Use of Non-invasive continuous hemodynamic monitoring (electrocardiometry) to guide management of septic shock in ch

Sponsors

Dr Mounika Reddy
Lead Sponsor

Eligibility

Inclusion criteria

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

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 7. Not willing to participate in the study

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
MortalityTimepoint: 28 days;o Length of PICU stay and hospital stayTimepoint: length of stay;o Organ dysfunction scores (pSOFA and PELOD-2) at 24, 48 and 72 hoursTimepoint: 24, 48 and 72 hours;o Proportion of children achieving shock resolution at 6, 12, 24, 48 and 72 hours of resuscitation.Timepoint: 6, 12, 24, 48 and 72 hours—

Countries

India

Contacts

Public ContactMounika Reddy Vadhi

St Johns Medical College and Hospital

doc.mounikareddy@gmail.com08022065000

Outcome results

None listed

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