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

Effect of Intravenous Administration of 20% Mannitol on the Optic Nerve Sheath Diameter(ONSD) in Patients With Raised Intracranial Pressure

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04188353
Enrollment
40
Registered
2019-12-05
Start date
2019-02-24
Completion date
2019-09-24
Last updated
2019-12-16

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

Conditions

Raised Intracranial Pressure

Keywords

ONSD, Mannitol, ICP

Brief 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.

Detailed description

This is a prospective cohort based observational study including 40 patients admitted in the adult ICU at our center diagnosed as either a case of TBI/ acute stroke/ intracranial hemorrhages with a mean screening ONSD of more than 5mm under mannitol osmotherapy. ONSD were measured by a high frequency linear array probe (\>10 Hz) at the time of screening. Mannitol was then administered at doses prescribed by the treating physician over 20-30 minutes via a dedicated intravenous line. ONSDs were measured again at 30, 60 and 120 minutes after completion of administration of mannitol. Demographic data, baseline ventilator parameters of patients on mechanical ventilation, GCS and mean arterial pressure at each time points were recorded. Comparison of variables at these time points were made.

Interventions

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

DRUGMannitol

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

Sponsors

Tribhuvan University Teaching Hospital, Institute Of Medicine.
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* age \> 18 years * diagnosed as a case of TBI/ acute stroke/ intracranial hemorrhages * screening mean ONSD \> 5 mm * under osmotherapy with mannitol in standard doses (0.25 - 1 gm/kg)

Exclusion criteria

* baseline ocular pathology like tumors, Graves' disease and sarcoidosis * previous ocular surgery * Decompressive cranial surgery

Design outcomes

Primary

MeasureTime frameDescription
optic nerve sheath diameter at 30, 60 and 120 minutes after mannitol administration30, 60 and 120 minutesChange in optic nerve sheath diameter (ONSD)

Secondary

MeasureTime frameDescription
Correlation between change in ONSD and Mean arterial pressure30, 60, and 120 minutesCorrelation with change in ONSD and Mean arterial pressure
Correlation between dose and change in ONSD30, 60 and 120 minutesDose subgroups of \<0.5gm/kg and \>/= 0.5 gm/kg were compared and the correlated with changes in ONSD.

Other

MeasureTime frameDescription
Comparison of ONSD values among ventilated and non-ventilated patients30, 60 and 120 minutesComparison of ONSD values among ventilated and non-ventilated patients at 30,60 and 120 minutes

Countries

Nepal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026