Comparison of Two Different Medications Used to Treat Elevated Intracranial Pressure

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Thomas Jefferson University
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00359697
First received: August 1, 2006
Last updated: March 28, 2014
Last verified: March 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00359697

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

No publications provided

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00359697     History of Changes
Other Study ID Numbers: 06U.132
Study First Received: August 1, 2006
Last Updated: March 28, 2014
Health Authority: United States: Food and Drug Administration

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
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014