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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
Information provided by (Responsible Party):
Thomas Jefferson University Identifier:
First received: August 1, 2006
Last updated: November 5, 2014
Last verified: November 2014
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

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

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
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Please refer to this study by its identifier: NCT00359697

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

Responsible Party: Thomas Jefferson University Identifier: NCT00359697     History of Changes
Other Study ID Numbers: 06U.132
Study First Received: August 1, 2006
Last Updated: November 5, 2014

Additional relevant MeSH terms:
Intracranial Hypertension
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Diuretics, Osmotic
Natriuretic Agents
Physiological Effects of Drugs processed this record on August 23, 2017