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Completed

NCT Number: NCT06846307

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

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.

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Key information

Conditions

Anesthesia Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Traumatic Brain Injury Wounds and Injuries

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dr. Kariadi Central General Hospital

Semarang, Central Java, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mannitol

Drug

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

Other names: Otsu-Mannitol 20

Primary outcomes

  1. Osmolarity

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

    Blood osmolarity (mOsm/L)

Sponsors and collaborators

Lead sponsor

Universitas Diponegoro

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 26, 2025
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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