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Clinical Trials/NCT02029820
NCT02029820
Unknown
Phase 3

RenalGuard System for Prevention of Contrast Induced Nephropathy - A Randomized Trial

Hospital Sao Lucas da PUCRS1 site in 1 country210 target enrollmentAugust 2012
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ConditionsRadiographic Contrast Agent Nephropathy

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Radiographic Contrast Agent Nephropathy
Sponsor
Hospital Sao Lucas da PUCRS
Enrollment
210
Locations
1
Primary Endpoint
Incidence of contrast-induced nephropathy
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The purpose of this study is to determine whether hydration with intravenous saline matched with urine output, using the device RenalGuard is superior to standard hydration with saline to prevent contrast-induced nephropathy.

Registry
clinicaltrials.gov
Start Date
August 2012
End Date
December 2015
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Vitor Osorio Gomes

MD, PhD

Hospital Sao Lucas da PUCRS

Eligibility Criteria

Inclusion Criteria

  • •serum creatinine \>1.2mg/dl
  • •glomerular filtration rate (GFR) \< 60ml/min

Exclusion Criteria

  • •acute renal failure
  • •use of radiological contrast in the latest 7 days
  • •Current use of N-acetylcysteine or hydration of sodium bicarbonate
  • •Patients in dialysis
  • •Emergency procedures

Outcomes

Primary Outcomes

Incidence of contrast-induced nephropathy

Time Frame: 72 hours

Contrast-induced nephropathy defined as an increase of serum creatinine of 0.5mg/dl or 25% in pre procedure serum creatinine at 72h after procedure

Study Sites (1)

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