Prevention of Contrast Renal Injury With Different Hydration Strategies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

396 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2013-01-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Contrast Medium-induced Nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Standard therapy

Hydration with 0.9% saline per a standard protocol (control group)

Group Type ACTIVE_COMPARATOR

Standard hydration

Intervention Type OTHER

LVEDP-based hydration strategy

LVEDP guided hydration with 0.9% saline (treatment group)

Group Type EXPERIMENTAL

LVEDP -Based hydration strategy

Intervention Type OTHER

Interventions

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LVEDP -Based hydration strategy

Intervention Type OTHER

Standard hydration

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No