Prevention of Contrast Renal Injury With Different Hydration Strategies

Phase 3

Completed

• Conditions: Contrast Medium-induced Nephropathy
• Interventions: Other: Standard hydration; Other: LVEDP -Based hydration strategy

• Registration Number: NCT01218828
• Lead Sponsor: Kaiser Permanente

Brief Summary

Using a randomized controlled trial design, two hydration protocols for the prevention of contrast medium-induced nephropathy will be tested.

Detailed Description

The study population will be recruited from subjects undergoing cardiac catheterization.

Subjects will be randomized to one of two hydration protocols:

1. normal saline at 3 mL/kg for one hour prior to contrast exposure and 1.5 mL/kg/hr during and for four hours post procedure.

2. normal saline at 3 mL/kg for one hour prior to contrast exposure and then the fluid rate would be adjusted according to the left ventricular end diastolic pressure (LVEDP). The fluid rate based upon the LVEDP measurement is maintained during the procedure and for four hours post procedure. The LVEDP hydration strategy follows: (2A) \< 13 mmHg, 5 mL/kg/hr during and for four hours post procedure. (2B) 13-18 mmHg, 3 mL/kg during and for four hours post procedure. (2C) \> 18 mmHg, 1.5 mL/kg during and four hours post procedure.

Renal function assessment will be made using standard laboratory measures post procedure.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-08
• Study First Submitted QC: 2010-10-08
• Study First Posted: 2010-10-11
• Primary Completion: 2012-08
• Study Completion: 2013-01
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-10
• Last Update Posted: 2015-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 396

Inclusion Criteria

• estimated GFR less than or equal to 60 mL/min/1.73 m^2
• age greater than 18 years
• at least one of the following: diabetes mellitus, history of congestive heart failure, hypertension, or age greater than 75 years.

Exclusion Criteria

• patients unable to give consent
• undergoing emergency cardiac catheterization
• on renal replacement therapy
• exposure to contrast media within the prior two days
• pulmonary edema or active congestive heart failure
• kidney transplant status
• severe valvular abnormalities
• change in serum creatinine greater than 15% over the prior two days

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard therapy	Standard hydration	Hydration with 0.9% saline per a standard protocol (control group)
LVEDP-based hydration strategy	LVEDP -Based hydration strategy	LVEDP guided hydration with 0.9% saline (treatment group)

Primary Outcome Measures

Name	Time	Method
Contrast induced nephropathy	Within four days of contrast exposure

Secondary Outcome Measures

Name	Time	Method
Renal replacement therapy, myocardial infarction, all-cause mortality	30 days and long-term

Trial Locations

Locations (1)

Kaiser Permanente; 🇺🇸 Los Angeles, California, United States