Clinical trial NCT04188353: Effect of Intravenous Administration of Mannitol on ONSD in Patients With Raised ICP
Official title: Effect of Intravenous Administration of 20% Mannitol on the Optic Nerve Sheath Diameter(ONSD) in Patients With Raised Intracranial Pressure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Raised Intracranial Pressure
Keywords: ONSD
Mannitol
ICP
Lead sponsor: Tribhuvan University Teaching Hospital, Institute Of Medicine.
Sponsor class: OTHER
First posted: 2019-12-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Admitted in the ICU of Tribhuvan university teaching hospital within the time period of the study

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.

Eligibility criteria: 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

Primary outcomes:
measure: optic nerve sheath diameter at 30, 60 and 120 minutes after mannitol administration
timeFrame: 30, 60 and 120 minutes
Secondary outcomes:
measure: Correlation between change in ONSD and Mean arterial pressure
timeFrame: 30, 60, and 120 minutes
measure: Correlation between dose and change in ONSD
timeFrame: 30, 60 and 120 minutes
Other outcomes:
measure: Comparison of ONSD values among ventilated and non-ventilated patients
timeFrame: 30, 60 and 120 minutes
Locations:
city: Kathmandu
country: Nepal
facility: Maharajgunj Medical Campus
state: Bagmati
Study officials:
affiliation: Institution of medicine, Tribhuvan University, Nepal
name: Shiva P Paudyal, MD
role: PRINCIPAL_INVESTIGATOR
References: