NCT00149721

Brief Summary

Hydrocephalus (secondary or idiopathic) is a condition characterized by dilatation of the lateral and third ventricles, and often associated with increased intracranial pressure (ICP). We hypothesize that either the ventricle dilatation or the increased ICP may cause disturbances in the hypothalamic-pituitary axis, resulting in different degrees of hypopituitarism. The goal of this study is to determine the prevalence of hypopituitarism in adult patients with hydrocephalus.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

March 2, 2010

Status Verified

March 1, 2010

First QC Date

September 7, 2005

Last Update Submit

March 1, 2010

Conditions

Normal Pressure Hydrocephalus

Keywords

hydrocephaluspituitary functionshunting

Outcome Measures

Primary Outcomes (1)

  • anterior pituitary function

Secondary Outcomes (1)

  • well being

Interventions

Ventriculo-peritonal shuntingPROCEDURE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of idiopathic hydrocephalus, made by clinical and CT or MRI imaging demonstrating ventricular dilation, and confirmed by an established protocol of continuous CSF drainage via spinal catheter. Patients who are found to be eligible for VP shunt insertion on the basis of improvement in cognition/psychomotor speed, gait, or urinary continence are referred for surgery

You may not qualify if:

  • Known peripheral gland failure (primary hypogonadism, primary adrenal insufficiency, primary hypothyroidism); known history of pituitary tumor, pituitary surgery, pituitary hemorrhage, brain irradiation, or of identified causes of secondary hydrocephalus (subarachnoidal bleeding, meningitis, encephalitis, head trauma).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GCRC Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Hydrocephalus, Normal PressureHydrocephalus

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Roberto Salvatori, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 8, 2005

Study Start

September 1, 2005

Study Completion

December 1, 2007

Last Updated

March 2, 2010

Record last verified: 2010-03

Locations

US(1)