A clinical trial to study the effects of two drugs,20% mannitol and 3% saline in children with raised intracranial pressure and acute central nervous system infections.
Not Applicable
- Conditions
- Health Condition 1: null- RAISED INTRACRANIAL PRESSURE DUE TO ACUTE CNS INFECTIONS
- Registration Number
- CTRI/2011/09/001997
- Lead Sponsor
- ADVANCED PEDIATRIC CENTRE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
Child aged 1 to 12 years presenting with raised ICP (clinical signs or on CT head)7 due to acute CNS infections and m-GCS ≤ 8 will be eligible for study.
Exclusion Criteria
1.Patients with raised ICP due to causes other than acute CNS infections.
2.Contraindications to insertion of ICP transducer because of coagulopathy, infection at the site of insertion, subdural and epidural infection.
3.Neurodevelopmental delay or chronic neurological illness.
4.Patients who have already received more than one dose of mannitol and /or 3% saline in last 24hours.
5.History of illness more than 7days of duration.
6.Clinical brain death as specified by human organ transplant act 1994
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The comparison of 20% mannitol vs 3% hypertonic saline in lowering of acute rise in ICP AT 72HOURS OF STUDY PERIODTimepoint: The comparison of 20% mannitol vs 3% hypertonic saline in lowering of acute rise in ICP.
- Secondary Outcome Measures
Name Time Method GCS improvement after 72 hours of enrollment <br/ ><br> (Sedation will be stopped 1hour before assessment) <br/ ><br> 2. The side effects of 3% hypertonic saline and 20% mannitol (Appendix V). <br/ ><br> 3. Neurological outcomes at discharge <br/ ><br>Timepoint: AFTER 72HOURS AND PICU OUTCOME