The Effect of Mannitol Volume With Changes in Osmolarity... | NCT06846307

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

NCT06846307

Sponsor

Universitas Diponegoro

Status

Completed

Last Update Posted

Jun 11, 2026Actual

Enrollment

64Actual

Phase

Phase 3

Conditions

Anesthesia
Traumatic Brain Injury

Interventions

Mannitol

Countries

Indonesia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2023Actual

Primary Completion Date

Jan 29, 2024Actual

Completion Date

Jan 31, 2024Actual

First Submitted Date

Feb 4, 2025

First Submission Date that Met QC Criteria

Feb 22, 2025

First Posted Date

Feb 26, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 8, 2026

Last Update Posted Date

Jun 11, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Taufik Saputra, Resident of Anesthesiology and Intensive Care, Medical Doctor, Universitas DiponegoroPrincipal Investigator

Lead Sponsor

Universitas DiponegoroOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

64Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mannitol 1	Active Comparator	3×0.25 g/kg	Drug: Mannitol
Mannitol 2	Active Comparator	2×0.5 g/kg	Drug: Mannitol
Mannitol 3	Active Comparator	3×0.5 g/kg	Drug: Mannitol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mannitol	Drug	mannitol administration across all three dosages given as an IV drip for 15-20 minutes	Mannitol 1 Mannitol 2 Mannitol 3

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Aria P Hayanto, Sp.An-TI	Universitas Diponegoro	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dr. Kariadi Central General Hospital		Semarang	Central Java		Indonesia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000070642	Brain Injuries, Traumatic
D001930	Brain Injuries
D014947	Wounds and Injuries

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D006259	Craniocerebral Trauma

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008353	Mannitol

Ancestor Terms

ID	Term
D013402	Sugar Alcohols
D000438	Alcohols
D009930	Organic Chemicals
D002241	Carbohydrates

Browse Leaves

Not provided

Browse Branches

Not provided