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Effect of Intravenous Administration of Mannitol on ONSD in Patients With Raised ICP

NCT04188353 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2019-12-16

No results posted yet for this study

Summary

Osmotherapy with mannitol has been a common practice in patients with raised ICP. Monitoring its effect on ICP can be performed invasively and non-invasively. Due to a validated correlation between invasive ICP monitoring and ONSD measurement, it can be a tool to monitor acute and long term effects of osmotherapy non-invasively on ICP. This study examines the acute changes in sonographically measured ONSD brought about by the administration of mannitol. This can correlate with the changes in ICP in such patients and can be utilized as a tool for decision making/ point-of-care utility.

Conditions

  • Raised Intracranial Pressure

Interventions

DEVICE

Optic nerve sheath diameter measurement

ONSD measurements done at screening (T1), 30 minutes after mannitol infusion (T2), 60 minutes (T3) and 120 minutes (T4)

DRUG

Mannitol

Mannitol at dose of 0.25 to 1 gm/kg over 20 minutes via a dedicated IV line

Sponsors & Collaborators

  • Tribhuvan University Teaching Hospital, Institute Of Medicine.

    lead OTHER

Principal Investigators

  • Shiva P Paudyal, MD · Institution of medicine, Tribhuvan University, Nepal

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-24
Primary Completion
2019-08-24
Completion
2019-09-24
FDA Drug
Yes
FDA Device
Yes

Countries

  • Nepal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04188353 on ClinicalTrials.gov