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RenalGuard System for Prevention of Contrast Induced Nephropathy (REPRECIN)

Primary Purpose

Radiographic Contrast Agent Nephropathy

Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
RenalGuard
Sponsored by
Hospital Sao Lucas da PUCRS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Radiographic Contrast Agent Nephropathy focused on measuring Contrast Nephropathy, Prevention, Renalguard

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital São Lucas -PUCRS, Serviço de HemodinâmicaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

RenalGuard

Saline

Arm Description

Hydration with the device renalguard

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 6, 2014
Last Updated
January 6, 2014
Sponsor
Hospital Sao Lucas da PUCRS
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1. Study Identification

Unique Protocol Identification Number
NCT02029820
Brief Title
RenalGuard System for Prevention of Contrast Induced Nephropathy
Acronym
REPRECIN
Official Title
RenalGuard System for Prevention of Contrast Induced Nephropathy - A Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Sao Lucas da PUCRS

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiographic Contrast Agent Nephropathy
Keywords
Contrast Nephropathy, Prevention, Renalguard

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RenalGuard
Arm Type
Active Comparator
Arm Description
Hydration with the device renalguard
Arm Title
Saline
Arm Type
No Intervention
Arm Description
Hydration with saline 1ml/Kg/h for 12h
Intervention Type
Device
Intervention Name(s)
RenalGuard
Intervention Description
Intravenous saline hydration matched with urine output, using the device Renalguard
Primary Outcome Measure Information:
Title
Incidence of contrast-induced nephropathy
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aryadina Piva, RN
Phone
55 51 33203494
Email
pesquisa@cardiarte.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vitor O Gomes, MD,PhD
Organizational Affiliation
Hospital Sao Lucas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital São Lucas -PUCRS, Serviço de Hemodinâmica
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90610-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aryadina Piva, RN
Phone
55 51 3320 3494
Email
pesquisa@cardiarte.com.br
First Name & Middle Initial & Last Name & Degree
Vitor O Gomes, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

RenalGuard System for Prevention of Contrast Induced Nephropathy

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