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

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.

Study Overview

• Status: Completed
• Conditions: Raised Intracranial Pressure
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Nepal
  • Bagmati
    • Kathmandu, Bagmati, Nepal, 44600
      • Maharajgunj Medical Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Admitted in the ICU of Tribhuvan university teaching hospital within the time period of the study

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between change in ONSD and Mean arterial pressure	Correlation with change in ONSD and Mean arterial pressure	30, 60, and 120 minutes
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Tribhuvan University Teaching Hospital, Institute Of Medicine.
• Investigators: Principal Investigator: Shiva P Paudyal, MD, Institution of medicine, Tribhuvan University, Nepal

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2019
• Primary Completion (Actual): August 24, 2019
• Study Completion (Actual): September 24, 2019

Study Registration Dates

• First Submitted: November 9, 2019
• First Submitted That Met QC Criteria: December 4, 2019
• First Posted (Actual): December 5, 2019

Study Record Updates

• Last Update Posted (Actual): December 16, 2019
• Last Update Submitted That Met QC Criteria: December 13, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: ICP; Mannitol; ONSD
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hypertension; Physiological Effects of Drugs; Natriuretic Agents; Diuretics, Osmotic; Diuretics; Mannitol
• Other Study ID Numbers: 360(6-11)E^2/075/76

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Hospital inpatient number, age, sex, weight, BMI, dose of mannitol administered, MAP, ONSD at T1, T2, T3, T4 and change in ONSD T1, T2, T3 and T4.
• IPD Sharing Time Frame: 2 years
• IPD Sharing Access Criteria: Contact with the PI
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• 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