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Nephrogenic Systemic Fibrosis With Gadollinum (NSF)

I

Imam Khomeini Hospital

Status and phase

Unknown
Phase 3
Phase 2

Conditions

Nephrogenic Systemic Fibrosis
Renal Failure

Treatments

Drug: gadollinum

Study type

Interventional

Funder types

Other

Identifiers

NCT01359345
6553-30-04-86
GADOLLINUM

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Renal Failure
  • Use of Gadollinum

Exclusion criteria

  • No consent
  • Age under 18

Trial design

Primary purpose

Screening

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

200 participants in 1 patient group

A
Experimental group
Description:
The patients with renal failure in whom Gadollinume has being used
Treatment:
Drug: gadollinum

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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