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
Not Applicable
Completed
- 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
- Registration Number
- CTRI/2015/10/006264
- Lead Sponsor
- AIIMS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 152
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method To evaluate the difference if any, between the therapy guided by the two techniques with regard to the following secondary objectives such as â?? <br/ ><br> <br/ ><br>a)Mortality <br/ ><br>b)Serum blood lactate levels and base deficit at the end of 6 hours <br/ ><br>c)Duration of PICU stay and the duration of ventilation <br/ ><br>d)PELOD score <br/ ><br> <br/ ><br>Timepoint: â?¢In-hospital mortality <br/ ><br>â?¢Blood lactate level and base deficit at 6 hours after intervention <br/ ><br>â?¢Duration of PICU stay and duration of mechanical ventilation in PICU <br/ ><br> <br/ ><br>â?¢PELOD score at 24 and 48 hours <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br>