Status:
COMPLETED
Maintenance Intravenous Fluids in Children
Lead Sponsor:
All India Institute of Medical Sciences
Conditions:
Hyponatremia
Eligibility:
All Genders
3-12 years
Phase:
PHASE3
Brief Summary
Hyponatraemia arises in between 20% and 45% of sick hospitalized children. An important reason for this high incidence could be use of hypotonic fluids in sick children for maintenance fluid therapy. ...
Detailed Description
Hyponatraemia arises in between 20% and 45% of sick hospitalized children. An important reason for this high incidence could be use of hypotonic fluids in sick children for maintenance fluid therapy. ...
Eligibility Criteria
Inclusion
- All children (3 months to 12 years) who are admitted to pediatric ward or pediatric ICU, who require exclusive intravenous maintenance fluid therapy for at least 24 hours will be eligible for the study
Exclusion
- Children with illness that have primary fluid and electrolyte imbalance such as:
- Shock: Defined as acute circulatory failure resulting in decreased tissue perfusion and manifesting as altered sensorium, hypothermia (\<35oC), tachycardia, prolonged capillary filling time (\>3 seconds), hypotension (BP \< 5th percentile for age), oliguria (\<0.5 ml/kg/hr), hypoxemia, hyperlactatemia, requirement of fluid bolus and/ or vasopressors.
- Diarrhea and Dehydration: Children presenting with diarrhea and features of dehydration: lethargy, irritability and altered sensorium, thirst, decreased urine output, sunken eyes \& dry mucous membranes, loss of skin elasticity.; children with ongoing diarrhea will be excluded even if there is no dehydration.
- Fluid Overload: Cirrhosis, Congestive heart failure, Acute and Chronic renal failure, Nephrotic syndrome.
- Abnormal serum sodium or Hyperglycemia at Presentation:
- Hyponatremia : serum sodium \< 130 mmol/L.
- Hypernatremia : serum sodium \>150 mmol/L.
- Hyperglycemia: blood glucose \> 180 mg/ dl.
- Severe Protein Energy Malnutrition: Defined as grade III (50-59% of expected weight for age) and grade IV (less than 50% of expected weight for age) as per IAP classification.
- Child who is receiving drugs which cause abnormality in serum sodium such as diuretics, vasopressin, etc.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
167 Patients enrolled
Trial Details
Trial ID
NCT00621348
Start Date
September 1 2006
End Date
May 1 2008
Last Update
August 10 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India, 110029