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

The Effect of Mannitol Volume Administration With Changes in Osmolarity in Traumatic Brain Injury: An Observational Study

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06846307
Enrollment
64
Registered
2025-02-26
Start date
2023-11-01
Completion date
2024-01-31
Last updated
2026-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Traumatic Brain Injury

Keywords

brain injury, intracranial pressure, mannitol, neurocritical care, osmolarity, trauma

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 prospective observational cohort study included 64 non-operative TBI patients admitted to Dr. Kariadi Central General Hospital, Semarang, Indonesia, between November 2023 and January 2024. Patients received one of three routine clinical regimens: 3×0.25 g/kg, 2×0.5 g/kg, or 3×0.5 g/kg body weight. Mannitol was administered intravenously over 15-20 minutes per dose. Plasma osmolarity was measured at baseline and at 6 and 24 hours following initial administration.

Interventions

DRUGMannitol

mannitol administration across all three dosages given as an IV drip for 15-20 minutes

Sponsors

Universitas Diponegoro
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
OsmolarityAt baseline (before administration) and subsequently at 6 hours and 24 hours post-administrationBlood osmolarity (mOsm/L)

Countries

Indonesia

Contacts

STUDY_DIRECTORAria P Hayanto, Sp.An-TI

Universitas Diponegoro

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 12, 2026