The Effect of Mannitol Volume with Changes in Osmolarity in Traumatic Brain Injury

February 26, 2025 updated by: Taufik Saputra, Universitas Diponegoro

The Effect of Mannitol Volume Administration with Changes in Osmolarity in Traumatic Brain Injury: an Observational Study

This observational study is designed to research the effect of mannitol volume administration with changes in osmolarity in patients with traumatic brain injury to guide the safe use of mannitol in these patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study used an analytic observational design with a prospective cohort approach to evaluate the relationship between mannitol administration volume and changes in osmolarity in TBI patients at Dr. Kariadi Central General Hospital, Semarang, Indonesia. The study included 32 non-operative TBI patients admitted to the Emergency Department (ED) and inpatient wards from November 2023 to January 2024. Samples were selected using a consecutive sampling method based on the inclusion criteria. The independent variable in this study was the volume of mannitol administered (3x125 cc, 2x250 cc, 3x250 cc; each 250 cc contains 50g mannitol) given as an IV drip for 15-20 minutes, while the dependent variable was blood osmolarity (mOsm/L).

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • Central Java
      • Semarang, Central Java, Indonesia
        • Dr. Kariadi Central General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients aged 18-40 years
  • Glasgow Coma Scale (GCS) score indicating mild (14-13) or moderate (12-10)

Exclusion Criteria:

  • Renal impairment
  • Multiple trauma with bleeding shock
  • Diabetes mellitus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Mannitol 1
mannitol 3x125 cc
Drug: Mannitol
mannitol administration across all three dosages (3x125 cc, 2x250 cc, 3x250 cc) given as an IV drip for 15-20 minutes
Other Names:
  • Otsu-Mannitol 20
Active Comparator: Mannitol 2
Mannitol 2x250 cc
Drug: Mannitol
mannitol administration across all three dosages (3x125 cc, 2x250 cc, 3x250 cc) given as an IV drip for 15-20 minutes
Other Names:
  • Otsu-Mannitol 20
Active Comparator: Mannitol 3
Mannitol 3x250 cc
Drug: Mannitol
mannitol administration across all three dosages (3x125 cc, 2x250 cc, 3x250 cc) given as an IV drip for 15-20 minutes
Other Names:
  • Otsu-Mannitol 20

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Osmolarity
Time Frame: At baseline (before administration) and subsequently at 6 hours and 24 hours post-administration
Blood osmolarity (mOsm/L)
At baseline (before administration) and subsequently at 6 hours and 24 hours post-administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitas Diponegoro

Investigators

  • Study Director: Aria P Hayanto, Sp.An-TI, Universitas Diponegoro

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Actual)

January 29, 2024

Study Completion (Actual)

January 31, 2024

Study Registration Dates

First Submitted

February 4, 2025

First Submitted That Met QC Criteria

February 22, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 26, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1554/EC/KEPK-RSDK/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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