NCT00359697

Brief Summary

The overall purpose of this study is to compare the effects of mannitol and hypertonic saline on patients with increased intracranial pressure. The hypothesis being tested is that hypertonic saline is more effective in controlling increased intracranial pressure than mannitol.

Trial Health

50
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 2, 2006

Completed
Last Updated

November 6, 2014

Status Verified

November 1, 2014

First QC Date

August 1, 2006

Last Update Submit

November 5, 2014

Conditions

Increased Intracranial Pressure

Outcome Measures

Primary Outcomes (1)

  • Reduction of ICP below treatment threshold (less than 20 mmHg)

Secondary Outcomes (1)

  • Compare effects of each treatment on MAP, CPP, serum and urine sodium and osmolality

Interventions

Hypertonic Saline, MannitolDRUG

Eligibility Criteria

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

You may qualify if:

  • Documented SAH (by computed tomography or lumbar puncture), ICH, TBI or brain tumor
  • Patient greater than or equal to 18 years of age
  • ICP monitor in place
  • ICP greater than 20mmHg, not related to a transient noxious stimulus and not responding to standard measures for controlling ICP (ventricular drainage, elevation of head of the bed and optimizing PaCO2)
  • Patient or patient's legally authorized representative has provided written informed consent

You may not qualify if:

  • Patient less than 18 years of age
  • Lack of ICP monitoring
  • Patient received Mannitol prior to placement of ICP monitor
  • Baseline serum osmolarity of greater than 310 mOsm/L
  • Patient is currently enrolled in another investigational drug or device study
  • Congestive heart failure at time of enrollment
  • Chronic renal failure on hemodialysis
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Intracranial Hypertension

Interventions

Saline Solution, HypertonicMannitol

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Hypertonic SolutionsSolutionsPharmaceutical PreparationsSugar AlcoholsAlcoholsOrganic ChemicalsCarbohydrates

Study Officials

  • Robert H Rosenwasser, MD

    Thomas Jefferson University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2006

First Posted

August 2, 2006

Last Updated

November 6, 2014

Record last verified: 2014-11