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

Phase 3

Completed

• Conditions: Anesthesia; Traumatic Brain Injury
• Interventions: Drug: Mannitol

• Registration Number: NCT06846307
• Lead Sponsor: Universitas Diponegoro

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.

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 Timeline

• Study Start: 2023-11-01
• Primary Completion: 2024-01-29
• Study Completion: 2024-01-31
• Status Verified: 2025-02
• Study First Submitted: 2025-02-04
• Study First Submitted QC: 2025-02-22
• Study First Posted: 2025-02-26
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mannitol 1	Mannitol	mannitol 3x125 cc
Mannitol 2	Mannitol	Mannitol 2x250 cc
Mannitol 3	Mannitol	Mannitol 3x250 cc

Primary Outcome Measures

Name	Time	Method
Osmolarity	At baseline (before administration) and subsequently at 6 hours and 24 hours post-administration	Blood osmolarity (mOsm/L)

Trial Locations

Locations (1)

Dr. Kariadi Central General Hospital; 🇮🇩 Semarang, Central Java, Indonesia