NCT02037815

Brief Summary

Osmotherapy has been used as the medical treatment for brain edema and intracranial hypertension in critically brain injured patients. Measurement of serum osmolality during osmotherapy is of clinical importance to determine clinical efficacy, adjust dosage and avoid side effect. Serum osmolality is often measured in laboratory by cryoscopic technique as the reference method. However, in clinical setting, routine measurement of serum osmolality is not feasible at bedside, either in intensive care unit (ICU) or neurosurgical ward. Therefore, clinicians usually estimate serum osmolality by using equations derived from serum osmoles that can be measured by bedside blood gas analysis or routine laboratory chemical analysis, such as sodium, potassium, urea, and glucose. In present study, mannitol or hypertonic saline will be used in patients after craniotomy, and serum osmolality will be measured before and during drug infusion. Investigators hypothesize that the correlation of measured and calculated serum osmolality is better during infusion of hypertonic saline than mannitol.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2014

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 16, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

July 30, 2014

Status Verified

July 1, 2014

Enrollment Period

3 months

First QC Date

January 13, 2014

Last Update Submit

July 29, 2014

Conditions

Brain Edema

Keywords

hyperosmolar drugsmannitolhypertonic salineserum osmolalitycorrelation

Outcome Measures

Primary Outcomes (1)

  • Difference between the measured and calculated serum osmolality.

    Immediately before the infusion of mannitol and hypertonic saline, and 15, 30, 60, 120, 240, and 360 minutes after the administration of the study drugs

Secondary Outcomes (2)

  • Serum osmolality

    Immediately before the infusion of mannitol and hypertonic saline, and 15, 30, 60, 120, 240, and 360 minutes after the administration of the study drugs

  • Concentration of serum sodium

    Immediately before the infusion of mannitol and hypertonic saline, and 15, 30, 60, 120, 240, and 360 minutes after the administration of the study drugs

Study Arms (2)

Mannitol

EXPERIMENTAL

20% mannitol solution, 125 ml, IV infusion in 15 min

Drug: 20% mannitol solution, 125 ml, IV infusion in 15 min

Hypertonic saline

EXPERIMENTAL

3.1% sodium chloride solution, 125 ml, IV infusion in 15 min

Drug: 3.1% sodium chloride solution, 125 ml, IV infusion in 15 min

Interventions

20% mannitol solution, 125 ml, IV infusion in 15 minDRUG
Mannitol
3.1% sodium chloride solution, 125 ml, IV infusion in 15 minDRUG
Hypertonic saline

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients after elective craniotomy, requiring hyperosmolar agents for prevention or treatment of brain edema

You may not qualify if:

  • age younger than 18 yr or older than 65 yr
  • history of diabetes
  • unstable hemodynamic condition
  • presence of renal failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neurosurgical ICU, Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location

Related Publications (2)

  • Li Q, Chen H, Hao JJ, Yin NN, Xu M, Zhou JX. Agreement of measured and calculated serum osmolality during the infusion of mannitol or hypertonic saline in patients after craniotomy: a prospective, double-blinded, randomised controlled trial. BMC Anesthesiol. 2015 Oct 7;15:138. doi: 10.1186/s12871-015-0119-4.

    PMID: 26445777DERIVED

  • Li Q, Xu M, Zhou JX. Correlation of measured and calculated serum osmolality during mannitol or hypertonic saline infusion in patients after craniotomy: a study protocol and statistical analysis plan for a randomised controlled trial. BMJ Open. 2014 Apr 23;4(4):e004921. doi: 10.1136/bmjopen-2014-004921.

    PMID: 24760352DERIVED

MeSH Terms

Conditions

Brain Edema

Interventions

Infusions, IntravenousSodium Chloride

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Administration, IntravenousDrug Administration RoutesDrug TherapyTherapeuticsInfusions, ParenteralChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Jian-Xin Zhou, MD

    Neurosurgical ICU, Beijing Tiantan Hospital, Capital Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 13, 2014

First Posted

January 16, 2014

Study Start

January 1, 2014

Primary Completion

April 1, 2014

Study Completion

June 1, 2014

Last Updated

July 30, 2014

Record last verified: 2014-07

Locations

CN(1)