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Comparing a New Non-Invasive Monitoring Method with Standard Care in Children with Severe Infection-Related Shock: A Pilot Study

Continuous non-invasive advanced hemodynamic monitoring versus standard care for the management of pediatric septic shock - A pilot randomized control trial - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/10/075496
Enrollment
60
Registered
2024-10-18
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-11

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: Continuous non-invasive cardiac output monitor: The subjects randomized to the intervention arm will be connected to the portable hand- held continuous non-invasive cardiac output monit

Sponsors

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 or hypoperfusion after the initial 20ml per kg fluid bolus or 1000 ml fluid bolus in patients weighing over 50 kg, received within last 4 hours

Exclusion criteria

Exclusion criteria: Exclusion criteria: - Preterm babies with corrected age less than 2 months - Children with fulminant myocarditis or cardiomyopathy - Children with unrepaired congenital heart disease or cardiac failure - Children with severe acute malnutrition - Known chronic renal failure defined as requiring renal replacement therapy - Known chronic hepatic failure - Already on inotropes for more than 2 hours - Suffered cardiorespiratory arrest within less than 2 hours requiring cardiopulmonary resuscitation of more than 2 mins duration - Moribund patients with anticipated survival less than 24 hrs - Not willing to participate in the study

Design outcomes

Primary

MeasureTime frame
To evaluate the difference between the two groups in terms of survival free of organ dysfunctionTimepoint: At 28 days

Secondary

MeasureTime frame
Time to achieve therapeutic end-points of shock resolutionTimepoint: till discharge;Fluid overload percentageTimepoint: 24, 48 and 72 hours;Length of PICU stay and hospital stayTimepoint: till discharge;Early and late mortalityTimepoint: 7 and 28 day;Physiological markers including lactate - Inotropes, ventilation, other organ supportTimepoint: till discharge

Countries

India

Contacts

Public ContactDr Mounika Vadhi Reddy

All India Institute of Medical Sciences Bibinagar

doc.mounikareddy@gmail.com9855784739

Outcome results

None listed

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