RenalGuard System for Prevention of Contrast Induced Nephropathy

Phase 3UnknownNCT02029820

Hospital Sao Lucas da PUCRS210 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

210

Conditions

Radiographic Contrast Agent Nephropathy

Interventions

RenalGuardDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital São Lucas -PUCRS, Serviço de Hemodinâmica

Porto Alegre, Rio Grande do Sul, Brazil

RECRUITING

Outcomes

Primary Outcomes

Incidence of contrast-induced nephropathy

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

Time frame: 72 hours

Central Contacts

Aryadina Piva, RN

CONTACT

55 51 33203494 pesquisa@cardiarte.com.br

Data from ClinicalTrials.gov

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