RenalGuard System for Prevention of Contrast Induced Nephropathy (REPRECIN)

January 6, 2014 updated by: Vitor Osorio Gomes, Hospital Sao Lucas da PUCRS

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

210

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 90610-000
        • Recruiting
        • Hospital São Lucas -PUCRS, Serviço de Hemodinâmica
        • Contact:
        • Principal Investigator:
          • Vitor O Gomes, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: RenalGuard
Hydration with the device renalguard
Device: RenalGuard
Intravenous saline hydration matched with urine output, using the device Renalguard
No Intervention: Saline
Hydration with saline 1ml/Kg/h for 12h

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of contrast-induced nephropathy
Time Frame: 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
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Sao Lucas da PUCRS

Investigators

  • Principal Investigator: Vitor O Gomes, MD,PhD, Hospital sao lucas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

January 6, 2014

First Submitted That Met QC Criteria

January 6, 2014

First Posted (Estimate)

January 8, 2014

Study Record Updates

Last Update Posted (Estimate)

January 8, 2014

Last Update Submitted That Met QC Criteria

January 6, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11/05339

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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