Nephrogenic Systemic Fibrosis With Gadollinum

Phase 2

• Conditions: Renal Failure; Nephrogenic Systemic Fibrosis
• Interventions: Drug: gadollinum

• Registration Number: NCT01359345
• Lead Sponsor: Imam Khomeini Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2008-07
• Study First Submitted: 2009-10-26
• Primary Completion: 2011-05
• Study First Submitted QC: 2011-05-23
• Study First Posted: 2011-05-24
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-21
• Last Update Posted: 2012-06-22
• Study Completion: 2012-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Renal Failure
• Use of Gadollinum

Exclusion Criteria

• No consent
• Age under 18

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	gadollinum	The patients with renal failure in whom Gadollinume has being used

Primary Outcome Measures

Name	Time	Method
occurrence of fibrosis	after 2 month of exposure with gadollinum

Trial Locations

Locations (1)

Tehran Heart Center; 🇮🇷 Tehran, Iran, Islamic Republic of