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The Use of Renal Guard System in Patients Undergoing CRT Implantation

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01936142
Enrollment
0
Registered
2013-09-05
Start date
2013-09-30
Completion date
2014-09-30
Last updated
2016-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury

Keywords

Resynchroniztion therapy, Kidney, Contrast media, Prevention

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.

Interventions

DEVICEUse of RenalGuard

Sponsors

Tel-Aviv Sourasky Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Renal function24 and 48 hours post implantation and 8-11 days post implantation, 6 month post implantaionChange in Renal function will be measured by change in serum creatinine (mg/dl)

Secondary

MeasureTime frame
Left ventricular lead implantation success1 day post implantation

Other

MeasureTime frame
Mortality6 month
Hospitalization due to infection6 month

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026