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Comparison of Two Different Medications Used to Treat Elevated Intracranial Pressure

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2014 by Thomas Jefferson University.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00359697
First Posted: August 2, 2006
Last Update Posted: November 6, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Thomas Jefferson University
  Purpose
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.

Condition Intervention Phase
Increased Intracranial Pressure Drug: Hypertonic Saline, Mannitol Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Randomized Clinical Trialto Compare Mannitol and Hypertonic Saline for Treatment of Increased Intracranial Pressure

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • Reduction of ICP below treatment threshold (less than 20 mmHg)

Secondary Outcome Measures:
  • Compare effects of each treatment on MAP, CPP, serum and urine sodium and osmolality

Estimated Enrollment: 50
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00359697


Sponsors and Collaborators
Thomas Jefferson University
Investigators
Principal Investigator: Robert H Rosenwasser, MD Thomas Jefferson University
  More Information

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00359697     History of Changes
Other Study ID Numbers: 06U.132
First Submitted: August 1, 2006
First Posted: August 2, 2006
Last Update Posted: November 6, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
Intracranial Hypertension
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Mannitol
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs