Chronic Kidney DiseaseNCT00769834
Disc Edema in Patients With Chronic Kidney Disease
An observational study of Chronic Kidney Disease, run by University of Mississippi Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Kidney Disease
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Apr 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- All patients who have been identified to have kidney disease (as defined by the K/DOQI Clinical Practice Guidelines for Chronic Kidney Disease-2002)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Mississippi Medical Center
Jackson, Mississippi, 39216
About this study
Official title: Incidence and Causes of Disc Edema in Patients With Chronic Kidney Disease
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.
Read more
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.
Read the 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.
- Conditions
- Chronic Kidney Disease
- Keywords
- chronic kidney disease, chronic renal insufficiency, uremia, disc edema, papilledema, idiopathic intracranial hypertension, pseudotumor cerebri
- Medical subject headings
- Renal Insufficiency, Chronic, Uremia, Papilledema, Pseudotumor Cerebri
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
disc edema
Measured: 0 days
Secondary outcomes (2)
ophthalmoscopic diagnosis
Measured: 0 days
neurologic diagnosis
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2008 (estimated)
- Study startJan 2010
- Primary completionDec 2010 (estimated)
- Study completionApr 2011 (estimated)
Why it stopped: All investigators have moved to different oranizations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sachin Kedar, University of Nebraska
- Investigators
- SACHIN KEDAR, M.D, Principal investigator, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00769834
- Sponsor's protocol ID
- 2008-0019
- Status last verified
- Feb 2018
- First submitted
- 8 Oct 2008
- Last updated
- 28 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17763231Chang 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.
PubMed 15590543Dogulu 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.
PubMed 15520772Khositseth 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.
PubMed 15378420Francis 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.
PubMed 14586682Obeid 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.
PubMed 9364317Koller 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.
PubMed 9260244Katz B. Disk edema subsequent to renal transplantation. Surv Ophthalmol. 1997 Jan-Feb;41(4):315-20. doi: 10.1016/s0039-6257(96)00006-9.
PubMed 9104768Sheth 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.
PubMed 8142239Chang 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.
PubMed 1525975Niutta 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.
PubMed 1562126Hamed 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.
PubMed 2750832National 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.
PubMed 11904577Guy 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.
PubMed 2296378Taban 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.
PubMed 17368544
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Causes of Disc Edema in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT00769834
- Acronym / sponsor ID
- 2008-0019
- Conditions
- Chronic Kidney Disease
- Keywords
- chronic kidney disease, chronic renal insufficiency, uremia, disc edema, papilledema, idiopathic intracranial hypertension, pseudotumor cerebri
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: All investigators have moved to different oranizations
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Apr 2011 (estimated)
- First posted
- 9 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- All patients who have been identified to have kidney disease (as defined by the K/DOQI Clinical Practice Guidelines for Chronic Kidney Disease-2002)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
disc edema
Time frame: 0 days
2 secondary outcomes
ophthalmoscopic diagnosis
Time frame: 0 days
neurologic diagnosis
Time frame: 1 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
- Background: PubMed 17763231Im L, Atabay C, Eller AW. Papilledema associated with dialysis disequilibrium syndrome. Semin Ophthalmol. 2007 Jul-Sep;22(3):133-5. doi: 10.1080/08820530701421585.
- Background: PubMed 15590543Chang 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.
- Background: PubMed 15520772Dogulu 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.
- Background: PubMed 15378420Khositseth 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.
- Background: PubMed 14586682Francis 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.
- Background: PubMed 9364317Obeid 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.
- Background: PubMed 9260244Koller 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.
- Background: PubMed 9104768Katz B. Disk edema subsequent to renal transplantation. Surv Ophthalmol. 1997 Jan-Feb;41(4):315-20. doi: 10.1016/s0039-6257(96)00006-9.
- Background: PubMed 8142239Sheth 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.
- Background: PubMed 1525975Chang 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.
- Background: PubMed 1562126Niutta 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.
- Background: PubMed 2750832Hamed 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SACHIN KEDAR, M.D principal investigator
University of Mississippi Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease, run by University of Mississippi Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disc edema (time frame: 0 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00769834, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2018.