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Comparison of Two Different Medications Used to Treat Elevated Intracranial Pressure

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. Identifier: NCT00359697
Recruitment Status : Unknown
Verified November 2014 by Thomas Jefferson University.
Recruitment status was:  Not yet recruiting
First Posted : August 2, 2006
Last Update Posted : November 6, 2014
Information provided by (Responsible Party):
Thomas Jefferson University

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.

Condition or disease Intervention/treatment Phase
Increased Intracranial Pressure Drug: Hypertonic Saline, Mannitol Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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 the National Library of Medicine

Drug Information available for: Mannitol

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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 identifier (NCT number): NCT00359697

Sponsors and Collaborators
Thomas Jefferson University
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Principal Investigator: Robert H Rosenwasser, MD Thomas Jefferson University
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Responsible Party: Thomas Jefferson University Identifier: NCT00359697    
Other Study ID Numbers: 06U.132
First Posted: August 2, 2006    Key Record Dates
Last Update Posted: November 6, 2014
Last Verified: November 2014
Additional relevant MeSH terms:
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Intracranial Hypertension
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Diuretics, Osmotic
Natriuretic Agents
Physiological Effects of Drugs