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The Use of Renal Guard System in Patients Undergoing CRT Implantation

Primary Purpose

Acute Kidney Injury

Status
Withdrawn
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Use of RenalGuard
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Kidney Injury focused on measuring Resynchroniztion therapy, Kidney, Contrast media, Prevention

Eligibility Criteria

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

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

Sites / Locations

  • Tel Aviv Souraky MC

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

No RenalGuard

RenalGuard

Arm Description

Control group will undergo CRT implantation without using RenalGuard

Use of the RenalGuard system during CRT implantation

Outcomes

Primary Outcome Measures

Change in Renal function
Change in Renal function will be measured by change in serum creatinine (mg/dl)

Secondary Outcome Measures

Left ventricular lead implantation success

Full Information

First Posted
August 22, 2013
Last Updated
July 6, 2016
Sponsor
Tel-Aviv Sourasky Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01936142
Brief Title
The Use of Renal Guard System in Patients Undergoing CRT Implantation
Official Title
The Effect of Forced Diuresis With Matched Hydration in Reducing Acute Kidney Injury During CRT Implantation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Withdrawn
Why Stopped
No suitable patient found
Study Start Date
September 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tel-Aviv Sourasky Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury
Keywords
Resynchroniztion therapy, Kidney, Contrast media, Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No RenalGuard
Arm Type
No Intervention
Arm Description
Control group will undergo CRT implantation without using RenalGuard
Arm Title
RenalGuard
Arm Type
Experimental
Arm Description
Use of the RenalGuard system during CRT implantation
Intervention Type
Device
Intervention Name(s)
Use of RenalGuard
Primary Outcome Measure Information:
Title
Change in Renal function
Description
Change in Renal function will be measured by change in serum creatinine (mg/dl)
Time Frame
24 and 48 hours post implantation and 8-11 days post implantation, 6 month post implantaion
Secondary Outcome Measure Information:
Title
Left ventricular lead implantation success
Time Frame
1 day post implantation
Other Pre-specified Outcome Measures:
Title
Mortality
Time Frame
6 month
Title
Hospitalization due to infection
Time Frame
6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: eligible for CRT implantation estimated GFR < 60ml/min/1.73m2 Exclusion Criteria: On Dialysis Sensitivity to Furosemide Contraindication for urinary catheter Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoav Michowich, MD
Organizational Affiliation
Tel Aviv Sourasky MC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tel Aviv Souraky MC
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Use of Renal Guard System in Patients Undergoing CRT Implantation

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