RenalGuard System for Prevention of Contrast Induced Nephropathy

Phase 3

• Conditions: Radiographic Contrast Agent Nephropathy
• Interventions: Device: RenalGuard

• Registration Number: NCT02029820
• Lead Sponsor: Hospital Sao Lucas da PUCRS

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Status Verified: 2014-01
• Study First Submitted: 2014-01-06
• Study First Submitted QC: 2014-01-06
• Last Update Submitted: 2014-01-06
• Study First Posted: 2014-01-08
• Last Update Posted: 2014-01-08
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 210

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RenalGuard	RenalGuard	Hydration with the device renalguard

Primary Outcome Measures

Name	Time	Method
Incidence of contrast-induced nephropathy	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

Trial Locations

Locations (1)

Hospital São Lucas -PUCRS, Serviço de Hemodinâmica; 🇧🇷 Porto Alegre, RS, Brazil