Prevention of Contrast Renal Injury With Different Hydration Strategies (POSEIDON)

Kaiser Permanente

Status and phase: Completed; Phase 3

Conditions: Contrast Medium-induced Nephropathy

Treatments: Other: LVEDP -Based hydration strategy; Other: Standard hydration

Study type: Interventional

Funder types: Other

Identifiers

NCT01218828

KP-RCCL-5718

Details and patient eligibility

About

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

Full 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.

Enrollment: 396 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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396 participants in 2 patient groups

Standard therapy

Active Comparator group

Description:

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

Treatment:

Other: Standard hydration

LVEDP-based hydration strategy

Experimental group

Description:

LVEDP guided hydration with 0.9% saline (treatment group)

Treatment:

Other: LVEDP -Based hydration strategy