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

NCT04188353 | Completed DMC FDA Drug FDA Device

• 1 other identifier: 360(6-11)E^2/075/76
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Raised Intracranial Pressure

Keywords

ONSD; Mannitol; ICP

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Correlation between change in ONSD and Mean arterial pressure

  30, 60, and 120 minutes

• Correlation between dose and change in ONSD

  30, 60 and 120 minutes

Other Outcomes (1)

• Comparison of ONSD values among ventilated and non-ventilated patients

  30, 60 and 120 minutes

Interventions

Optic nerve sheath diameter measurement DEVICE

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

Also known as: ONSD

Mannitol DRUG

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

Also known as: Osmotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• baseline ocular pathology like tumors, Graves' disease and sarcoidosis
• previous ocular surgery
• Decompressive cranial surgery

Sponsors & Collaborators

• Tribhuvan University Teaching Hospital, Institute Of Medicine.: lead

Study Sites (1)

Maharajgunj Medical Campus

Kathmandu, Bagmati, 44600, Nepal

Location

MeSH Terms

Conditions

Intracranial Hypertension

Interventions

Mannitol

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Study Officials

• Shiva P Paudyal, MD

  Institution of medicine, Tribhuvan University, Nepal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident, PGY-III, Anesthesiology

Study Record Dates

• First Submitted: November 9, 2019
• First Posted: December 5, 2019
• Study Start: February 24, 2019
• Primary Completion: August 24, 2019
• Study Completion: September 24, 2019
• Last Updated: December 16, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 2 years
• Access Criteria: Contact with the PI

Locations

NE (1)