RenalGuard System for Prevention of Contrast Induced Nephropathy (REPRECIN)

Hospital Sao Lucas da PUCRS

Status and phase: Unknown; Phase 3

Conditions: Radiographic Contrast Agent Nephropathy

Treatments: Device: RenalGuard

Study type: Interventional

Funder types: Other

Identifiers

NCT02029820

11/05339

Details and patient eligibility

About

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.

Enrollment: 210 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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210 participants in 2 patient groups

RenalGuard

Active Comparator group

Description:

Hydration with the device renalguard

Treatment:

Device: RenalGuard

Saline

No Intervention group

Description:

Hydration with saline 1ml/Kg/h for 12h