Maintenance intravenous fluid in childre
Phase 3
Completed
- Conditions
- Health Condition 1: null- admitted patients requiring maintenance intravenous fluid.
- Registration Number
- CTRI/2017/09/009639
- Lead Sponsor
- Chacha Nehru Bal Chikitsalaya
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 168
Inclusion Criteria
1.All hospitalized children between 3 months to 5 years requiring intravenous maintenance fluid for at least 24 hours.
Exclusion Criteria
1.Children with renal, hepatic or congestive heart failure
2.Children with hyponatremia (Na <135 meq/L) or hypernatremia (Na >145) at admission
3.Children with dehydration
4.Children requiring fluid boluses
5.Children who have received diuretics within last seven days
6.Children with severe malnutrition
7.Children with hemodynamic instability and requiring inotropes with or without mechanical ventilation
8.Children who had received intravenous fluid therapy in last 24 hours prior to admission
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of hyponatremia (serum Na 135 meq/L) in children receiving isotonic fluid (0.9% normal saline with 5% dextrose) in comparison to children receiving hypotonic fluid (0.45% normal saline with 5% dextrose)Timepoint: 0 hour <br/ ><br>12 hours <br/ ><br>24 hours
- Secondary Outcome Measures
Name Time Method Incidence of moderate (Na130 meq/L), severe (Na125 meq/L) and symptomatic hyponatremia (lethargy, altered sensorium or seizure) <br/ ><br> <br/ ><br>Change in serum sodium level from baseline <br/ ><br> <br/ ><br>Incidence of hypernatremia (serum Na 145 meq/L) <br/ ><br>Timepoint: 0 hour <br/ ><br>12 hours <br/ ><br>24 hours