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

Universitas Diponegoro

Status and phase: Completed; Phase 3

Conditions: Traumatic Brain Injury; Anesthesia

Treatments: Drug: Mannitol

Study type: Interventional

Funder types: Other

Identifiers

NCT06846307

1554/EC/KEPK-RSDK/2023

Details and patient eligibility

About

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.

Full 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).

Enrollment: 32 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

32 participants in 3 patient groups

Mannitol 1

Active Comparator group

Description:

mannitol 3x125 cc

Treatment:

Drug: Mannitol

Mannitol 2

Active Comparator group

Description:

Mannitol 2x250 cc

Treatment:

Drug: Mannitol

Mannitol 3

Active Comparator group

Description:

Mannitol 3x250 cc

Treatment:

Drug: Mannitol