Raised Intracranial PressureNCT04188353
Effect of Intravenous Administration of Mannitol on ONSD in Patients With Raised ICP
An observational study of Raised Intracranial Pressure, run by Tribhuvan University Teaching Hospital, Institute Of Medicine. at 1 site in Nepal.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Raised Intracranial Pressure
- What is being tested?
- Optic nerve sheath diameter measurement and Mannitol
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 40 participants
- Where
- 1 siteNepal
- Study dates
- 24 Feb 2019to 24 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Admitted in the ICU of Tribhuvan university teaching hospital within the time period of the study
Who may be able to join
- 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)
Who cannot join
- baseline ocular pathology like tumors, Graves' disease and sarcoidosis
- previous ocular surgery
- Decompressive cranial surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Raised Intracranial Pressure
- Being tested
- Optic nerve sheath diameter measurement, Mannitol
- Keywords
- ONSD, Mannitol, ICP
- Medical subject headings
- Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optic nerve sheath diameter measurementDevice
Also called ONSD
ONSD measurements done at screening (T1), 30 minutes after mannitol infusion (T2), 60 minutes (T3) and 120 minutes (T4)
MannitolDrug
Also called Osmotherapy
Mannitol at dose of 0.25 to 1 gm/kg over 20 minutes via a dedicated IV line
What is being measured
The primary outcome is the main question the study is designed to answer.
optic nerve sheath diameter at 30, 60 and 120 minutes after mannitol administration
Change in optic nerve sheath diameter (ONSD)
Measured: 30, 60 and 120 minutes
Secondary outcomes (2)
Correlation between change in ONSD and Mean arterial pressure
Correlation with change in ONSD and Mean arterial pressure
Measured: 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.
Measured: 30, 60 and 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start24 Feb 2019
- Primary completion24 Aug 2019
- Study completion24 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Raised Intracranial PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tribhuvan University Teaching Hospital, Institute Of Medicine.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shiva Prasad Paudyal, Tribhuvan University Teaching Hospital, Institute Of Medicine.
- Investigators
- Shiva P Paudyal, MD, Principal investigator, Institution of medicine, Tribhuvan University, Nepal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04188353
- Sponsor's protocol ID
- 360(6-11)E^2/075/76
- Status last verified
- Dec 2019
- First submitted
- 9 Nov 2019
- Last updated
- 16 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravenous Administration of 20% Mannitol on the Optic Nerve Sheath Diameter(ONSD) in Patients With Raised Intracranial Pressure
- ClinicalTrials.gov ID
- NCT04188353
- Acronym / sponsor ID
- 360(6-11)E^2/075/76
- Conditions
- Raised Intracranial Pressure
- Keywords
- ONSD, Mannitol, ICP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tribhuvan University Teaching Hospital, Institute Of Medicine.University, hospital or other
- Study start
- 24 Feb 2019 (actual)
- Primary completion
- 24 Aug 2019 (actual)
- Study completion
- 24 Sep 2019 (actual)
- First posted
- 5 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Admitted in the ICU of Tribhuvan university teaching hospital within the time period of the study
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- baseline ocular pathology like tumors, Graves' disease and sarcoidosis
- previous ocular surgery
- Decompressive cranial surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optic nerve sheath diameter measurementAlso: ONSDONSD measurements done at screening (T1), 30 minutes after mannitol infusion (T2), 60 minutes (T3) and 120 minutes (T4) | Device | – |
| MannitolAlso: OsmotherapyMannitol at dose of 0.25 to 1 gm/kg over 20 minutes via a dedicated IV line | Drug | – |
Primary outcome
optic nerve sheath diameter at 30, 60 and 120 minutes after mannitol administration
Time frame: 30, 60 and 120 minutes
Change in optic nerve sheath diameter (ONSD)
2 secondary outcomes
Correlation between change in ONSD and Mean arterial pressure
Time frame: 30, 60, and 120 minutes
Correlation between dose and change in ONSD
Time frame: 30, 60 and 120 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2019.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shiva P Paudyal, MD principal investigator
Institution of medicine, Tribhuvan University, Nepal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Raised Intracranial Pressure, run by Tribhuvan University Teaching Hospital, Institute Of Medicine. at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
optic nerve sheath diameter at 30, 60 and 120 minutes after mannitol administration (time frame: 30, 60 and 120 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2019.