Fluid bolus administration over 15-20 minutes versus 5-10 minutes each in children with septic shock
Phase 4
- Conditions
- Health Condition 1: null- Children 17 years of age with septic shockHealth Condition 2: A419- Sepsis, unspecified organism
- Registration Number
- CTRI/2014/09/005050
- Lead Sponsor
- PGIMER Dr RML Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 220
Inclusion Criteria
Children < 18 years of age with features of septic shock with or without hypotension would be included
Exclusion Criteria
1.Moderate to severely malnourished children (Indian Academy of Pediatrics classification for malnutrition grades 3 and 4)
2.Primary cardiac illness
3.Contraindication to central venous catheter insertion
4.Children with features of fluid overload at presentation
5.Children whose parents refuse to give an informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of children requiring mechanical ventilation and/or impaired oxygenation (Oxygenation Index) in those already on ventilator <br/ ><br>Timepoint: At 6 and 24 hours of admission
- Secondary Outcome Measures
Name Time Method To assess the effect of intervention on <br/ ><br>1.The amount of fluid required (in ml/kg) <br/ ><br>2. Inotropic score <br/ ><br>3.Proportion of children attaining therapeutic end points <br/ ><br>4.Duration of ventilation (in hours) <br/ ><br>5.Duration of inotropic support (in hours) <br/ ><br>6.Time to achieving therapeutic end points <br/ ><br>7.Duration of intensive care unit (ICU) stay <br/ ><br>8.Mortality and <br/ ><br>9. Serum pro-BNP levels <br/ ><br>Timepoint: 1. Amount of fluid required in first 6 and 24 hours. <br/ ><br>2. Inotropic score at 6 and 24 hours. <br/ ><br>3. Attaining therapeutic end points at 6 hours. <br/ ><br>4. Total duration of ventilation. <br/ ><br>5. Total time period to achieving therapeutic end points. <br/ ><br>6. Total duration of ICU stay <br/ ><br>7. Serum pro BNP levels at 1 and 6 hrs post initial fluid boluses