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RenalGuard System for Prevention of Contrast Induced Nephropathy

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02029820
Acronym
REPRECIN
Enrollment
210
Registered
2014-01-08
Start date
2012-08-31
Completion date
2015-12-31
Last updated
2014-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radiographic Contrast Agent Nephropathy

Keywords

Contrast Nephropathy, Prevention, Renalguard

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.

Interventions

Intravenous saline hydration matched with urine output, using the device Renalguard

Sponsors

Hospital Sao Lucas da PUCRS
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of contrast-induced nephropathy72 hoursContrast-induced nephropathy defined as an increase of serum creatinine of 0.5mg/dl or 25% in pre procedure serum creatinine at 72h after procedure

Countries

Brazil

Contacts

Primary ContactAryadina Piva, RN
pesquisa@cardiarte.com.br55 51 33203494

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026