The Use of Renal Guard System in Patients Undergoing CRT Implantation

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01936142
• Other study ID #: TASMC-13-0167-YMICH
• Status: Withdrawn
• Phase: N/A
• First received: August 22, 2013
• Last updated: July 6, 2016
• Start date: September 2013
• Est. completion date: September 2014

Study information

• Verified date: July 2016
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

Device:
• Use of RenalGuard

Locations

Country	Name	City	State
Israel	Tel Aviv Souraky MC	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mortality		6 month	Yes
Other	Hospitalization due to infection		6 month	Yes
Primary	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	Yes
Secondary	Left ventricular lead implantation success		1 day post implantation	No