The Use of Renal Guard System in Patients Undergoing CRT Implantation

NCT ID: NCT01936142

Last Updated: 2016-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Kidney Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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No RenalGuard

Control group will undergo CRT implantation without using RenalGuard

Group Type NO_INTERVENTION

No interventions assigned to this group

RenalGuard

Use of the RenalGuard system during CRT implantation

Group Type EXPERIMENTAL

Use of RenalGuard

Intervention Type DEVICE

Interventions

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Use of RenalGuard

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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michal roll

Head of Research and Development Division

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yoav Michowich, MD

Role: PRINCIPAL_INVESTIGATOR

Tel Aviv Sourasky MC

Locations

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Tel Aviv Souraky MC

Tel Aviv, , Israel

Site Status

Countries

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Israel

Other Identifiers

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TASMC-13-0167-YMICH

Identifier Type: -

Identifier Source: org_study_id

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