An observational study in Raised Intracranial Pressure, sponsored by Tribhuvan University Teaching Hospital, Institute Of Medicine.. Completed at 1 site in Nepal. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-16.
Sponsored by Tribhuvan University Teaching Hospital, Institute Of Medicine. · Observational
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.
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.
192 studies on the registry are indexed under Intracranial Hypertension; 46 are open to participants now.
This study's enrollment of 40 is below the median of 60 across 83 observational studies indexed under Intracranial Hypertension.
Browse Intracranial Hypertension studies →Tribhuvan University Teaching Hospital, Institute Of Medicine. is the lead sponsor of 41 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Admitted in the ICU of Tribhuvan university teaching hospital within the time period of the study
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
ONSD measurements done at screening (T1), 30 minutes after mannitol infusion (T2), 60 minutes (T3) and 120 minutes (T4)
Also known as: ONSD
Mannitol at dose of 0.25 to 1 gm/kg over 20 minutes via a dedicated IV line
Also known as: Osmotherapy
optic nerve sheath diameter at 30, 60 and 120 minutes after mannitol administration
Change in optic nerve sheath diameter (ONSD)
Time frame: 30, 60 and 120 minutes
Correlation between change in ONSD and Mean arterial pressure
Correlation with change in ONSD and Mean arterial pressure
Time frame: 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.
Time frame: 30, 60 and 120 minutes
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
Time frame: 30, 60 and 120 minutes
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: 2 years
Access criteria: Contact with the PI
Ran from Feb 2019 to primary completion in Aug 2019, 6 months.
Of 47 non-industry observational studies under Intracranial Hypertension, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 95. This study's 6 months is below that.
Counting every sponsor, half of 50 studies reached it within 31 months; a quarter within 11 and three quarters within 62.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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Tribhuvan University Teaching Hospital, Institute Of Medicine.