The Use of Renal Guard System in Patients Undergoing CRT Implantation

Not Applicable

Withdrawn

• Conditions: Acute Kidney Injury
• Interventions: Device: Use of RenalGuard

• Registration Number: NCT01936142
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-22
• Study Start: 2013-09
• Study First Submitted QC: 2013-09-04
• Study First Posted: 2013-09-05
• Primary Completion: 2014-06
• Study Completion: 2014-09
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-06
• Last Update Posted: 2016-07-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RenalGuard	Use of RenalGuard	Use of the RenalGuard system during CRT implantation

Primary Outcome Measures

Name	Time	Method
Change in Renal function	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)

Secondary Outcome Measures

Name	Time	Method
Left ventricular lead implantation success	1 day post implantation

Trial Locations

Locations (1)

Tel Aviv Souraky MC; 🇮🇱 Tel Aviv, Israel