Prevention of Contrast Nephropathy During Diagnostic Coronary Angiogram or PCI With Hydratation Based on LEVDP (NEPHRON)

Université de Sherbrooke

Status and phase: Unknown; Phase 4

Conditions: Renal Failure; Coronary Heart Disease; Radiographic Contrast Agent Nephropathy

Treatments: Other: Sodium bicarbonate; Other: Hydratation according LVEDP + NaHCO3; Other: normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT00584350

03-70-M5

Details and patient eligibility

About

The goal is to determine if prehydration based on LEVDP is superior to a standard hydratation with NaCl 0.9% or NaHCO3 for the prevention of contrast nephropathy related to a diagnostic coronary angiogram or to PCI.

Full description

The goal is to determine if prehydration based on LEVDP is superior to a standard hydratation, independant of volemic status, with NaCl 0.9% or NaHCO3 for the prevention of contrast nephropathy related to a diagnostic coronary angiogram or to PCI.

Enrollment: 330 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• minimum 18 years old
• chronic renal insufficiency with a calculated creatinine clearance below 60 cc /min. (estimated with the MDRD formula)
• hemodynamically stable

Exclusion criteria

• Acute renal failure or in recuperation of acute renal failure
• urgent coronary angiogram
• moderate to severe valvulopathy or presence of a valvular prosthesis
• diagnostic of multiple myeloma
• dialysis before test
• having had a test with contrast product in the 2 weeks preceding
• receiving a nephrotoxic in the last month.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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330 participants in 3 patient groups

A: Hydratation according LVEDP + NaHCO3

Experimental group

Description:

Hydration with bolus of NaCl 0.9 to reach a LVEDP of 18 mmHg or more. This procedure is done while the patient is in the laboratory, with a catheter in the left ventricle. At the same time, an infusion of a sodium bicarbonate solution (150 mEq/L) is started at a rate of 1 ml/kg/h (max 110 ml/h) for 7 hours.

Treatment:

Other: Hydratation according LVEDP + NaHCO3

B: Standard hydratation

Active Comparator group

Description:

hydratation with normal saline (1 cc/kg/h; max 110 cc/h) starting at 8PM the day before the test and ending at 8PM the day of the test (24 hours total).

Treatment:

Other: normal saline

C: Hydratation with sodium bicarbonate

Experimental group

Description:

hydratation with sodium bicarbonate (150 mEq/L) at 3 cc/kg/h (max 330 cc/h) for 1 hour before the test and then, to be continued at 1 cc/kg/h (max 110 cc/h) for 6 hours (total of 7 hours of hydratation).

Treatment:

Other: Sodium bicarbonate