NCT01936142

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2013

Completed
10 days until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

July 7, 2016

Status Verified

July 1, 2016

Enrollment Period

9 months

First QC Date

August 22, 2013

Last Update Submit

July 6, 2016

Conditions

Acute Kidney Injury

Keywords

Resynchroniztion therapyKidneyContrast mediaPrevention

Outcome Measures

Primary Outcomes (1)

  • Change in Renal function

    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 Outcomes (1)

  • Left ventricular lead implantation success

    1 day post implantation

Other Outcomes (2)

  • Mortality

    6 month

  • Hospitalization due to infection

    6 month

Study Arms (2)

No RenalGuard

NO INTERVENTION

Control group will undergo CRT implantation without using RenalGuard

RenalGuard

EXPERIMENTAL

Use of the RenalGuard system during CRT implantation

Device: Use of RenalGuard

Interventions

Use of RenalGuardDEVICE
RenalGuard

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • eligible for CRT implantation
  • estimated GFR \< 60ml/min/1.73m2

You may not qualify if:

  • On Dialysis
  • Sensitivity to Furosemide
  • Contraindication for urinary catheter
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv Souraky MC

Tel Aviv, 64239, Israel

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Yoav Michowich, MD

    Tel Aviv Sourasky MC

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Research and Development Division

Study Record Dates

First Submitted

August 22, 2013

First Posted

September 5, 2013

Study Start

September 1, 2013

Primary Completion

June 1, 2014

Study Completion

September 1, 2014

Last Updated

July 7, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)