NCT00769834|Withdrawn
Study Stopped
All investigators have moved to different oranizations
Disc Edema in Patients With Chronic Kidney Disease
Incidence and Causes of Disc Edema in Patients With Chronic Kidney Disease
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Sponsor study identifier
observational
0
1 country
1
Study Start
January 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 2011
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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 Although clinicians have observed that patients with kidney diseases have increased incidence of papilledema (unpublished data by Corbett et al), there have been no studies on this subject to date.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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2011
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 8, 2008
Actual (reported)October 9, 2008
Actual (reported)January 2010
Date type not reportedThis date has not been verified as actual or estimated.
December 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 2011
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
disc edema
0 days
ophthalmoscopic diagnosis
0 days
neurologic diagnosis
1 month
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.
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
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
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.
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.
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.
SACHIN KEDAR, M.D
University of Mississippi Medical Center
0 participants (actual enrollment reported by the registry).
First Submitted
October 8, 2008
First Posted
October 9, 2008
Study Start
January 2010
Date type not reportedThis date has not been verified as actual or estimated.
Calcium and Phosphorus Balance and Calcium Kinetics in Patients With Stage 3/4 Chronic Kidney Disease
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Primary Completion
December 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 2011
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 28, 2018
Record last verified: 2018-02
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