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

• Sponsor: Tribhuvan University Teaching Hospital, Institute Of Medicine. (Other)
• Overall Status: Completed
• CT.gov ID: NCT04188353
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Actual Duration (Months): 7
• Patients Per Site Per Month: 5.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Raised Intracranial Pressure	Device: Optic nerve sheath diameter measurement; Drug: Mannitol

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 40 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Effect of Intravenous Administration of 20% Mannitol on the Optic Nerve Sheath Diameter(ONSD) in Patients With Raised Intracranial Pressure
• Actual Study Start Date: Feb 24, 2019
• Actual Primary Completion Date: Aug 24, 2019
• Actual Study Completion Date: Sep 24, 2019

Outcome Measures

Primary Outcome Measures

1. optic nerve sheath diameter at 30, 60 and 120 minutes after mannitol administration [30, 60 and 120 minutes]

   Change in optic nerve sheath diameter (ONSD)

Secondary Outcome Measures

1. Correlation between change in ONSD and Mean arterial pressure [30, 60, and 120 minutes]

   Correlation with change in ONSD and Mean arterial pressure

2. Correlation between dose and change in ONSD [30, 60 and 120 minutes]

   Dose subgroups of <0.5gm/kg and >/= 0.5 gm/kg were compared and the correlated with changes in ONSD.

Other Outcome Measures

1. Comparison of ONSD values among ventilated and non-ventilated patients [30, 60 and 120 minutes]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maharajgunj Medical Campus	Kathmandu	Bagmati	Nepal	44600

Sponsors and Collaborators

• Tribhuvan University Teaching Hospital, Institute Of Medicine.

Investigators

• Principal Investigator: Shiva P Paudyal, MD, Institution of medicine, Tribhuvan University, Nepal

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Feb 24, 2019

More Information

Publications

None provided.

• Responsible Party: Shiva Prasad Paudyal, Resident, PGY-III, Anesthesiology, Tribhuvan University Teaching Hospital, Institute Of Medicine.
• ClinicalTrials.gov Identifier: NCT04188353
• Other Study ID Numbers: 360(6-11)E^2/075/76
• First Posted: Dec 5, 2019
• Last Update Posted: Dec 16, 2019
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Shiva Prasad Paudyal, Resident, PGY-III, Anesthesiology, Tribhuvan University Teaching Hospital, Institute Of Medicine.: ONSD; Mannitol; ICP
• Additional relevant MeSH terms: Intracranial Hypertension; Mannitol

Study Results

No Results Posted as of Dec 16, 2019