Improved Analysis Methods for Infusion Tests

This study has been completed.
Sponsor:
Information provided by:
Umeå University
ClinicalTrials.gov Identifier:
NCT01319136
First received: March 18, 2011
Last updated: NA
Last verified: March 2009
History: No changes posted

March 18, 2011
March 18, 2011
March 2009
August 2010   (final data collection date for primary outcome measure)
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No Changes Posted
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Improved Analysis Methods for Infusion Tests
Novel Infusion Method for Describing CSF Dynamics

Objective: Patients with Idiopathic Normal Pressure Hydrocephalus are improved with shunt surgery. To increase the accuracy of the diagnosis, supplementary tests that characterize the cerebrospinal fluid (CSF) dynamics are used. The infusion test is one of these, used for shunt surgery selection and postoperative evaluation of shunt function. Forty-eight patients that had a preoperative investigation because of communicating hydrocephalus at the university hospitals in Umeå and Uppsala, Sweden, participated in the study. The purpose of this study was to evaluate a new method, with a new infusion protocol and new analysis methods, and compare it to the current method.

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Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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Non-Probability Sample

Patients that had a preoperative investigation because of communicating hydrocephalus. MRI revealed ventriculomegaly (Evans ratio > 0.3), no obstruction to CSF flow at visual inspection. Most, but not all, fulfilled the criteria of "probable" or "possible" INPH.

Idiopathic Normal Pressure Hydrocephalus
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
August 2010
August 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • preoperative investigation because of communicating hydrocephalus
  • ventriculomegaly (Evans ratio > 0.3)
  • no obstruction to CSF flow at visual inspection

Exclusion Criteria:

  • postoperative infusion test investigations
  • patients that were unable to understand instructions
Both
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Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01319136
Dnr 08-130M
No
Kennet Andersson, MSc, Umeå University
Umeå University
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Study Director: Jan Malm, PhD, MD Department of Clinical Neuroscience
Umeå University
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP