The Use of Renal Guard System in Patients Undergoing CRT Implantation

July 6, 2016 updated by: michal roll, Tel-Aviv Sourasky Medical Center

The Effect of Forced Diuresis With Matched Hydration in Reducing Acute Kidney Injury During CRT Implantation

The purpose of this study is to determine whether the use of RenalGuard system which creates high urine output with fluid balancing may prevent contrast induced nephropathy in patient undergoing cardiac resynchronization therapy (CRT) implantation.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Israel
      • Tel Aviv, Israel, 64239
        • Tel Aviv Souraky MC

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:

  1. eligible for CRT implantation
  2. estimated GFR < 60ml/min/1.73m2

Exclusion Criteria:

  1. On Dialysis
  2. Sensitivity to Furosemide
  3. Contraindication for urinary catheter
  4. Pregnancy

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
No Intervention: No RenalGuard
Control group will undergo CRT implantation without using RenalGuard
Experimental: RenalGuard
Use of the RenalGuard system during CRT implantation
Device: Use of RenalGuard

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Renal function
Time Frame: 24 and 48 hours post implantation and 8-11 days post implantation, 6 month post implantaion
Change in Renal function will be measured by change in serum creatinine (mg/dl)
24 and 48 hours post implantation and 8-11 days post implantation, 6 month post implantaion

Secondary Outcome Measures

Outcome Measure
Time Frame
Left ventricular lead implantation success
Time Frame: 1 day post implantation
1 day post implantation

Other Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: 6 month
6 month
Hospitalization due to infection
Time Frame: 6 month
6 month

Collaborators and Investigators

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

Sponsor

Tel-Aviv Sourasky Medical Center

Investigators

  • Principal Investigator: Yoav Michowich, MD, Tel Aviv Sourasky MC

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

September 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

August 22, 2013

First Submitted That Met QC Criteria

September 4, 2013

First Posted (Estimate)

September 5, 2013

Study Record Updates

Last Update Posted (Estimate)

July 7, 2016

Last Update Submitted That Met QC Criteria

July 6, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TASMC-13-0167-YMICH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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