NCT06846307

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2023

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2024

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

February 4, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 26, 2025

Completed
Last Updated

March 3, 2025

Status Verified

February 1, 2025

Enrollment Period

3 months

First QC Date

February 4, 2025

Last Update Submit

February 26, 2025

Conditions

AnesthesiaTraumatic Brain Injury

Keywords

brain injuryintracranial pressuremannitolneurocritical careosmolaritytrauma

Outcome Measures

Primary Outcomes (1)

  • Osmolarity

    Blood osmolarity (mOsm/L)

    At baseline (before administration) and subsequently at 6 hours and 24 hours post-administration

Study Arms (3)

Mannitol 1

ACTIVE COMPARATOR

mannitol 3x125 cc

Drug: Mannitol

Mannitol 2

ACTIVE COMPARATOR

Mannitol 2x250 cc

Drug: Mannitol

Mannitol 3

ACTIVE COMPARATOR

Mannitol 3x250 cc

Drug: Mannitol

Interventions

MannitolDRUG

mannitol administration across all three dosages (3x125 cc, 2x250 cc, 3x250 cc) given as an IV drip for 15-20 minutes

Also known as: Otsu-Mannitol 20
Mannitol 1Mannitol 2Mannitol 3

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Kariadi Central General Hospital

Semarang, Central Java, Indonesia

Location

MeSH Terms

Conditions

Brain Injuries, TraumaticBrain InjuriesWounds and Injuries

Interventions

Mannitol

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous System

Intervention Hierarchy (Ancestors)

Sugar AlcoholsAlcoholsOrganic ChemicalsCarbohydrates

Study Officials

  • Aria P Hayanto, Sp.An-TI

    Universitas Diponegoro

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of Anesthesiology and Intensive Care, Medical Doctor

Study Record Dates

First Submitted

February 4, 2025

First Posted

February 26, 2025

Study Start

November 1, 2023

Primary Completion

January 29, 2024

Study Completion

January 31, 2024

Last Updated

March 3, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

ID(1)