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â??Early Goal Directed Therapy in Pediatric Septic Shock: Comparison of Outcomes using Continuous Superior Vena Cava Saturation (ScvO2) Monitoring versus Intermittent ScvO2 Monitoring Methods

â??Early goal directed therapy in pediatric septic shock: Comparison of outcomes using Intermittent versus Continuous ScvO2 Monitoring â?? A randomized non-inferiority trialâ??

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/10/006264
Enrollment
100
Registered
2015-10-15
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: null- Children less than equal to 15 years with features of fluid-refractory septic shock would be included. Health Condition 2: A419- Sepsis, unspecified organism

Interventions

Intervention1: Intermittent superior vena cava saturation estimation by cooximeter: 1: Experimental arm- â??Intermittent ScvO2â?? monitoring group â?? We will insert a central venous catheter (CVC) fo

Sponsors

AIIMS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children less than or equal to 15 years with features of fluid-refractory septic shock (who do not respond to initial fluid resuscitation of upto 40-60 ml/ kg of isotonic crystalloid/colloid bolus administered in about 1 hour period) would be included.

Exclusion criteria

Exclusion criteria: 1. Contraindication to central venous catheterization 2. Children with primary cardiac illness 3. Severe malnutrition 4. Children whose parents refuse to give an informed consent

Design outcomes

Primary

MeasureTime frame
To examine if intermittent monitoring of ScvO2 is not inferior to continuous monitoring in terms of resolution of shock at 6 hours in children with fluid refractory septic shockTimepoint: Proportion attaining therapeutic end points at the end of 6 hours in both groups—

Secondary

MeasureTime frame
To evaluate the difference if any, between the therapy guided by the two techniques with regard to the following secondary objectives such as â?? a) Mortality b) Serum blood lactate levels and base deficit at the end of 6 hours c) Duration of PICU stay and the duration of ventilation d) PELOD score Timepoint: â?¢ In-hospital mortality â?¢ Blood lactate level and base deficit at 6 hours after intervention â?¢ Duration of PICU stay and duration of mechanical ventilation in PICU â?¢ PELOD score at 24 and 48 hours—

Countries

India

Contacts

Public ContactJhuma Sankar

AIIMS, New Delhi

jhumaji@gmail.com9818399864

Outcome results

None listed

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