Nephrogenic Systemic Fibrosis With Gadollinum (NSF)
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Purpose
Recently there is increasing reports of NEPHROGENIIC SYSTEMIC FIBROSIS(NSF) in patients with severe renal failure mainly in patients under dialysis in whom gadollinum is being used.
The investigators will evaluate the prevalence and severity of NSF in patients with different degree of renal failure whom underwent imaging with Gadolinum.
| Condition | Intervention | Phase |
|---|---|---|
|
Nephrogenic Systemic Fibrosis Renal Failure |
Drug: gadollinum |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Screening |
| Official Title: | The Prevalence and Severity of Nephrogenic Systemic Fibrosis in Patients Whom Underwent Imaging With Gadollinium(MRI/MRA) in University Hospital of Tehran Heart Center in 2003-2008 |
- occurrence of fibrosis [ Time Frame: after 2 month of exposure with gadollinum ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 200 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | August 2012 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
The patients with renal failure in whom Gadollinume has being used
|
Drug: gadollinum
use of on injection gadollinum Iv for imaging
|
Detailed Description:
NSF is a progressive and potentially fatal disease reported mainly in End Stage Renal Disease (ESRD) patients in whom Gadolinume been used as contrast agent. Skin is the main organ of involvement but other vital organs like myocard,lung,liver may also be involved.Gadollinum is known as a safe contrast in renal disease patients in comparison with conventional nephrotoxic radiocontrast agents,but with increasing reports of NSF with Gadollinum the use of this agent in renal failure patients is under question.
We will retrospectively evaluate the occurrence of this complication in all patients with different degree of renal failure whom underwent MRA or MRI with Gadollinum in Tehran Heart Center since 2003 till now and we will describe the severity and distribution pattern of lesions and the relation of this complication to the severity of renal failure.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Renal Failure
- Use of Gadollinum
Exclusion Criteria:
- No consent
- Age under 18
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01359345
| Iran, Islamic Republic of | |
| Tehran Heart Center | |
| Tehran, Iran, Islamic Republic of | |
| Principal Investigator: | Mohammad R Khatami, MD | TUMS |
More Information
| Responsible Party: | Mohammad Reza Khatami, Associate professor, Imam Khomeini Hospital |
| ClinicalTrials.gov Identifier: | NCT01359345 History of Changes |
| Other Study ID Numbers: | GADOLLINUM 6553-30-04-86 |
| Study First Received: | October 26, 2009 |
| Last Updated: | June 21, 2012 |
| Health Authority: | Iran: Ethics Committee |
Keywords provided by Imam Khomeini Hospital:
|
NSF ESRD MRA |
MRI occurrence of NSF Use of Gadollinum |
Additional relevant MeSH terms:
|
Fibrosis Renal Insufficiency Nephrogenic Fibrosing Dermopathy Pathologic Processes |
Kidney Diseases Urologic Diseases Skin Diseases |
ClinicalTrials.gov processed this record on September 30, 2016