Nephrogenic Systemic Fibrosis With Gadollinum (NSF)

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

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.

Study Overview

• Status: Unknown
• Conditions: Renal Failure; Nephrogenic Systemic Fibrosis
• Intervention / Treatment: Drug: gadollinum

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Tehran Heart Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Renal Failure
• Use of Gadollinum

Exclusion Criteria:

• No consent
• Age under 18

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A; The patients with renal failure in whom Gadollinume has being used	Drug: gadollinum; use of on injection gadollinum Iv for imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
occurrence of fibrosis	after 2 month of exposure with gadollinum

Collaborators and Investigators

• Sponsor: Imam Khomeini Hospital
• Collaborators: Tehran Heart Center
• Investigators: Principal Investigator: Mohammad R Khatami, MD, TUMS

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): May 1, 2011
• Study Completion (Anticipated): August 1, 2012

Study Registration Dates

• First Submitted: October 26, 2009
• First Submitted That Met QC Criteria: May 23, 2011
• First Posted (Estimate): May 24, 2011

Study Record Updates

• Last Update Posted (Estimate): June 22, 2012
• Last Update Submitted That Met QC Criteria: June 21, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: MRI; ESRD; MRA; NSF; occurrence of NSF; Use of Gadollinum
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Fibrosis; Nephrogenic Fibrosing Dermopathy
• Other Study ID Numbers: GADOLLINUM; 6553-30-04-86