Disc Edema in Patients With Chronic Kidney Disease

NCT00769834 | Withdrawn

• 1 other identifier: 2008-0019
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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 Although clinicians have observed that patients with kidney diseases have increased incidence of papilledema (unpublished data by Corbett et al), there have been no studies on this subject to date.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.

Conditions

Chronic Kidney Disease

Keywords

chronic kidney disease; chronic renal insufficiency; uremia; disc edema; papilledema; idiopathic intracranial hypertension; pseudotumor cerebri

Outcome Measures

Primary Outcomes (1)

• disc edema

  0 days

Secondary Outcomes (2)

• ophthalmoscopic diagnosis

  0 days

• neurologic diagnosis

  1 month

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Mississippi Medical Center: lead

Study Sites (1)

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Related Publications (15)

• Im L, Atabay C, Eller AW. Papilledema associated with dialysis disequilibrium syndrome. Semin Ophthalmol. 2007 Jul-Sep;22(3):133-5. doi: 10.1080/08820530701421585.

  PMID: 17763231 BACKGROUND

• Chang S, Masaryk TJ, Lee MS. Optic nerve edema: complication of peripheral hemodialysis shunt. Semin Ophthalmol. 2004 Sep-Dec;19(3-4):88-90. doi: 10.1080/08820530490882319.

  PMID: 15590543 BACKGROUND

• Dogulu CF, Tsilou E, Rubin B, Fitzgibbon EJ, Kaiser-Kupper MI, Rennert OM, Gahl WA. Idiopathic intracranial hypertension in cystinosis. J Pediatr. 2004 Nov;145(5):673-8. doi: 10.1016/j.jpeds.2004.06.080.

  PMID: 15520772 BACKGROUND

• Khositseth S, Chavers BM, Czapansky-Beilman D, Mauer M. Idiopathic intracranial hypertension immediately after kidney transplantation in a pediatric recipient. Pediatr Nephrol. 2004 Dec;19(12):1416-7. doi: 10.1007/s00467-004-1616-8.

  PMID: 15378420 BACKGROUND

• Francis PJ, Haywood S, Rigden S, Calver DM, Clark G. Benign intracranial hypertension in children following renal transplantation. Pediatr Nephrol. 2003 Dec;18(12):1265-9. doi: 10.1007/s00467-003-1274-2. Epub 2003 Oct 30.

  PMID: 14586682 BACKGROUND

• Obeid T, Awada A, Huraib S, Quadri K, Abu-Romeh S. Pseudotumor cerebri in renal transplant recipients: a diagnostic challenge. J Nephrol. 1997 Sep-Oct;10(5):258-60.

  PMID: 9364317 BACKGROUND

• Koller EA, Stadel BV, Malozowski SN. Papilledema in 15 renally compromised patients treated with growth hormone. Pediatr Nephrol. 1997 Aug;11(4):451-4. doi: 10.1007/s004670050315.

  PMID: 9260244 BACKGROUND

• Katz B. Disk edema subsequent to renal transplantation. Surv Ophthalmol. 1997 Jan-Feb;41(4):315-20. doi: 10.1016/s0039-6257(96)00006-9.

  PMID: 9104768 BACKGROUND

• Sheth KJ, Kivlin JD, Leichter HE, Pan CG, Multauf C. Pseudotumor cerebri with vision impairment in two children with renal transplantation. Pediatr Nephrol. 1994 Feb;8(1):91-3. doi: 10.1007/BF00868279.

  PMID: 8142239 BACKGROUND

• Chang D, Nagamoto G, Smith WE. Benign intracranial hypertension and chronic renal failure. Cleve Clin J Med. 1992 Jul-Aug;59(4):419-22. doi: 10.3949/ccjm.59.4.419.

  PMID: 1525975 BACKGROUND

• Niutta A, Scorcia G, Princi P, Palombi E, Perilli R, Mannino G, Balacco Gabrieli C. Visual disturbances associated with primary empty sella syndrome in patients with chronic renal failure. Ann Ophthalmol. 1992 Feb;24(2):56-63.

  PMID: 1562126 BACKGROUND

• Hamed LM, Winward KE, Glaser JS, Schatz NJ. Optic neuropathy in uremia. Am J Ophthalmol. 1989 Jul 15;108(1):30-5. doi: 10.1016/s0002-9394(14)73256-8.

  PMID: 2750832 BACKGROUND

• National Kidney Foundation. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis. 2002 Feb;39(2 Suppl 1):S1-266. No abstract available.

  PMID: 11904577 BACKGROUND

• Guy J, Johnston PK, Corbett JJ, Day AL, Glaser JS. Treatment of visual loss in pseudotumor cerebri associated with uremia. Neurology. 1990 Jan;40(1):28-32. doi: 10.1212/wnl.40.1.28.

  PMID: 2296378 BACKGROUND

• Taban M, Taban M, Lee MS, Smith SD, Heyka R, Kosmorsky GS. Prevalence of optic nerve edema in patients on peripheral hemodialysis. Ophthalmology. 2007 Aug;114(8):1580-3. doi: 10.1016/j.ophtha.2006.10.060. Epub 2007 Mar 21.

  PMID: 17368544 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Uremia; Papilledema; Pseudotumor Cerebri

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Optic Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases; Intracranial Hypertension; Brain Diseases; Central Nervous System Diseases

Study Officials

• SACHIN KEDAR, M.D

  University of Mississippi Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Faculty

Study Record Dates

• First Submitted: October 8, 2008
• First Posted: October 9, 2008
• Study Start: January 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: April 1, 2011
• Last Updated: February 28, 2018

Record last verified: 2018-02

Locations

US (1)