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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-24

Study Completion Date

2019-09-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Raised Intracranial Pressure

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

ONSD Mannitol ICP

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Optic nerve sheath diameter measurement

ONSD measurements done at screening (T1), 30 minutes after mannitol infusion (T2), 60 minutes (T3) and 120 minutes (T4)

Intervention Type DEVICE

Mannitol

Mannitol at dose of 0.25 to 1 gm/kg over 20 minutes via a dedicated IV line

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ONSD Osmotherapy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Shiva Prasad Paudyal

Resident, PGY-III, Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Shiva P Paudyal, MD

Role: PRINCIPAL_INVESTIGATOR

Institution of medicine, Tribhuvan University, Nepal

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Maharajgunj Medical Campus

Kathmandu, Bagmati, Nepal

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Nepal

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

360(6-11)E^2/075/76

Identifier Type: -

Identifier Source: org_study_id