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Clinical Trials/CTRI/2012/05/002637
CTRI/2012/05/002637
Completed
Phase 3

A randomized controlled trial of intravenousmaintenance fluids ( isotonic vs hypotonic) in children with central nervous system infections.

Kalawati Saran Chiuldrens Hospital0 sites90 target enrollmentTBD
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ConditionsHealth Condition 1: null- to compare the incidence of hyponatremia with maintenance fluids ( isotonic and hypotonic) in children with CNS infections

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Health Condition 1: null- to compare the incidence of hyponatremia with maintenance fluids ( isotonic and hypotonic) in children with CNS infections
Sponsor
Kalawati Saran Chiuldrens Hospital
Enrollment
90
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
Kalawati Saran Chiuldrens Hospital

Eligibility Criteria

Inclusion Criteria

  • •children of age 2month to 5 years with a clinical diagonosis of CNS infections requiring maintenance fluids for atleast 24 hrs

Exclusion Criteria

  • •\-serum sodium less than 135 or more than 145 mmol/ L before starting maintenance fluids
  • •\- previously diagonosed renal disease
  • •\-documented cerebral salt wasting
  • •\-hepatic failure with fluid retention
  • •\-shock at presentation
  • •\-diarrhoea
  • •\-known endocrinal disorder(DI/IDDM/CAH)
  • •\-severe malnutrition(asTBW in malnourished children is 70\-80%as compared to 60% age matched well nourished controls)
  • •\-DKA/cranioenchephalic trauma (at risk of cerebral edema)

Outcomes

Primary Outcomes

Not specified

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