Disc Edema in Patients With Chronic Kidney Disease

This study has been withdrawn prior to enrollment.
(Study withdrawn due to logistic reasons and will be re-organized at a later date)
Sponsor:
Information provided by:
University of Mississippi Medical Center
ClinicalTrials.gov Identifier:
NCT00769834
First received: October 8, 2008
Last updated: April 28, 2009
Last verified: April 2009
  Purpose

Papilledema is defined as swelling of the optic nerves often due to increased intracranial pressure. When present, it often indicates life-threatening lesions of the brain such as tumors, abscesses, meningitis, encephalitis, venous sinus obstruction or intracranial hemorrhage. A similar clinical picture can also be caused by other conditions such as malignant hypertension, diabetic papillopathy and uremia. When the intracranial pressure is elevated in the absence of any known cause then it is called Idiopathic Intracranial Hypertension (IIH). Untreated papilledema can cause progressive optic nerve damage and blindness.

Patients with chronic kidney disease have a number of co-morbidities and thus are at an increased risk for developing papilledema. Although clinicians have observed that patients with kidney diseases have increased incidence of papilledema (unpublished data by Corbett et al), there have been no studies on this subject to date. We believe that a higher incidence of papilledema is found in patients with kidney diseases and this study could provide evidence to suggest routine ophthalmic screening in this patient group.

Hypothesis: The prevalence of optic disc swelling is increased in patients with chronic kidney disease.

Purpose: To establish the prevalence of disc edema in patients with chronic kidney disease.


Condition
Chronic Kidney Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Incidence and Causes of Disc Edema in Patients With Chronic Kidney Disease

Resource links provided by NLM:


Further study details as provided by University of Mississippi Medical Center:

Primary Outcome Measures:
  • disc edema [ Time Frame: 0 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • ophthalmoscopic diagnosis [ Time Frame: 0 days ] [ Designated as safety issue: No ]
  • neurologic diagnosis [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 323
Study Start Date: January 2010
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
CKD
The cohort comprises of patients who are diagnosed to have chronic kidney disease as defined by the K/DOQI Clinical Practice Guidelines for Chronic Kidney Disease-2002.

Detailed Description:

The craniospinal cavity is enclosed by a rigid, non-compressible bone and thus has a constant volume. It is filled with soft tissue (brain, spinal cord and connective tissue), cerebrospinal fluid (CSF) and circulating blood. Intracranial pressure (ICP) is the pressure of the fluid that bathes the brain and the spinal cord. The ICP is regulated by a fine balance between the production and absorption of CSF. Any disturbance in the volumes of the contents of the rigid craniospinal cavity will cause an alteration of the ICP. Intracranial pressure can be elevated from a number of disease processes such as space occupying lesions, abnormalities of the production and absorption of the CSF and abnormalities of the circulation such as venous obstruction.

Raised ICP will symptomatically manifest as headache, vomiting, tinnitus and diplopia in addition to neurologic symptoms related to the lesion location and type. The increased ICP can be transmitted to the optic nerves causing papilledema, defined as swelling of the optic nerve head (papilla) secondary to raised ICP. Swelling of the optic nerves in the absence of raised ICP is termed disc edema (Parsons JH, Miller NR). Causes of disc edema are extensive and include ischemic optic neuropathy, malignant hypertension, diabetic papillopathy, uremia, intracranial hypotension (CSF leak).

Papilledema is considered a medical emergency and is investigated by means of neuroimaging (to evaluate intracranial lesions) and lumbar puncture (to evaluate the opening pressure and CSF contents). A diagnosis of Idiopathic Intracranial Hypertension (IIH) is made when there is elevated ICP in the absence of clinical, laboratory or radiological evidence of any known cause of raised ICP.

The most feared complication of untreated papilledema is progressive optic nerve atrophy resulting in vision loss. Early recognition, investigation and treatment of papilledema and its causes can prevent blindness.

Patients with chronic kidney diseases have a number of risk factors which predispose them to the development of disc edema. Medical comorbidities such as hypertension and diabetes mellitus increase their risk for optic nerve head diseases such as ischemic optic neuropathy and diabetic papillopathy. Malignant hypertension, uremia and dialysis dysequilibrium syndrome also are known to cause papilledema.

There are no studies in the English literature to date, on disc edema in patients with kidney diseases. However, neuroophthalmologists have clinically observed that patients with chronic kidney diseases appear to have an increased incidence of optic nerve swelling (Corbett JJ, unpublished data). A study looking at optic nerve edema in this group of patients is overdue and may determine additional guidelines in the management of patients with chronic kidney diseases.

The patients enrolled in the study will undergo an optic nerve head examination by ophthalmoscopy to identify patients with disc edema. If disc edema is detected on the screening examination, the patients will be referred to the Neuroophthalmology service for evaluation and investigations to determine the further management. The results of the neuroophthalmologic workup for patients with disc edema will be reviewed to ascertain the etiology of disc edema.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study sample will be drawn from the population of patients with chronic kidney diseases attending the kidney disease clinics and the hemodialysis units at the University of Mississippi Medical Center and the Jackson Medical Mall

Criteria

Inclusion Criteria:

  • All patients who have been identified to have kidney disease (as defined by the K/DOQI Clinical Practice Guidelines for Chronic Kidney Disease-2002)

Exclusion Criteria:

  • Patients with renal transplantation
  • Patients who are less than 18 years of age
  • Patients who are unable to provide an informed consent to participate in the study.
  • Chronic Steroid use greater than or equal to 3 months within the last 6 months
  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: NCT00769834

Locations
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Sponsors and Collaborators
University of Mississippi Medical Center
Investigators
Principal Investigator: SACHIN KEDAR, M.D University of Mississippi Medical Center
  More Information

Publications:

Responsible Party: Sachin Kedar, University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT00769834     History of Changes
Other Study ID Numbers: 2008-0019
Study First Received: October 8, 2008
Last Updated: April 28, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Mississippi Medical Center:
chronic kidney disease
chronic renal insufficiency
uremia
disc edema
papilledema
idiopathic intracranial hypertension
pseudotumor cerebri

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on September 22, 2014