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

Raised Intracranial Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04188353
• Other study ID #: 360(6-11)E^2/075/76
• Status: Completed
• Start date: February 24, 2019
• Est. completion date: September 24, 2019

Study information

• Verified date: December 2019
• Source: Tribhuvan University Teaching Hospital, Institute Of Medicine.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 24, 2019
• Est. primary completion date: August 24, 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intracranial Hypertension
• Raised Intracranial Pressure

Intervention

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

Locations

Country	Name	City	State
Nepal	Maharajgunj Medical Campus	Kathmandu	Bagmati

Sponsors (1)

Lead Sponsor	Collaborator
Tribhuvan University Teaching Hospital, Institute Of Medicine.

Country where clinical trial is conducted

Nepal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Comparison of ONSD values among ventilated and non-ventilated patients	Comparison of ONSD values among ventilated and non-ventilated patients at 30,60 and 120 minutes	30, 60 and 120 minutes
Primary	optic nerve sheath diameter at 30, 60 and 120 minutes after mannitol administration	Change in optic nerve sheath diameter (ONSD)	30, 60 and 120 minutes
Secondary	Correlation between change in ONSD and Mean arterial pressure	Correlation with change in ONSD and Mean arterial pressure	30, 60, and 120 minutes
Secondary	Correlation between dose and change in ONSD	Dose subgroups of <0.5gm/kg and >/= 0.5 gm/kg were compared and the correlated with changes in ONSD.	30, 60 and 120 minutes