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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.

COMPARISON OF 20% MANNITOL VS 3% SALINE IN CHILDREN WITH RAISED INTRACRANIAL PRESSURE DUE TO ACUTE CNS INFECTIONS: A PILOT RANDOMIZED CONTROLLED TRIAL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2011/09/001997
Enrollment
30
Registered
2011-09-09
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- RAISED INTRACRANIAL PRESSURE DUE TO ACUTE CNS INFECTIONS

Interventions

Intervention1: 20%Mannitol : Mannitol (20%, 1100mOsm/l) will be administered at 0.5 gm/kg every 6hourly via intravenously over 30min for 48hours if the ICP more than20mmHg. Control Intervention1: 3%sa

Sponsors

ADVANCED PEDIATRIC CENTRE
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
GCS improvement after 72 hours of enrollment (Sedation will be stopped 1hour before assessment) 2. The side effects of 3% hypertonic saline and 20% mannitol (Appendix V). 3. Neurological outcomes at discharge Timepoint: AFTER 72HOURS AND PICU OUTCOME—

Countries

India

Contacts

Public ContactARUN BANSAL

P G I M E R

drarunbansal@gmail.com9815455002

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 8, 2026