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

NCT ID: NCT06846307

Last Updated: 2025-03-03

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2024-01-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Anesthesia Traumatic Brain Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mannitol 1

mannitol 3x125 cc

Group Type ACTIVE_COMPARATOR

Mannitol

Intervention Type DRUG

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

Mannitol 2

Mannitol 2x250 cc

Group Type ACTIVE_COMPARATOR

Mannitol

Intervention Type DRUG

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

Mannitol 3

Mannitol 3x250 cc

Group Type ACTIVE_COMPARATOR

Mannitol

Intervention Type DRUG

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

Interventions

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Mannitol

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

Intervention Type DRUG

Other Intervention Names

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Otsu-Mannitol 20

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universitas Diponegoro

OTHER

Sponsor Role lead

Responsible Party

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Taufik Saputra

Resident of Anesthesiology and Intensive Care, Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aria P Hayanto, Sp.An-TI

Role: STUDY_DIRECTOR

Universitas Diponegoro

Locations

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Dr. Kariadi Central General Hospital

Semarang, Central Java, Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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1554/EC/KEPK-RSDK/2023

Identifier Type: -

Identifier Source: org_study_id

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