Intravenous High Dose NAC and Sodium Bicarbonate for the Prevention of Contrast-induced Acute Injury

Federal University of São Paulo

Status: Completed

Conditions: Acute Renal Failure

Treatments: Drug: Intravenous NAC plus saline; Drug: NAC plus saline; Drug: NAC plus sodium bicarbonate plus saline; Drug: Sodium bicarbonate plus saline; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01612013

EPM1FU311281

Details and patient eligibility

About

Contrast-induced acute kidney injury is a common cause of acquired in-hospital renal insufficiency and is associated with prolonged hospitalization and unfavorable early and late outcomes. The investigators sought to compare 4 different strategies (intravenous high-dose of N-acetylcysteine, sodium bicarbonate, the combination of both, and saline alone) in the prevention of contrast-induced acute kidney injury in patients undergoing coronary angiography using high-osmolar contrast media defined by creatinine and cystatin C serum levels.

Enrollment: 500 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• eligible patients include individuals aged 18 year or older with normal renal function who were schedule to undergo cardiac catheterization. During the randomized study, consecutive eligible patients schedule for exposure to the ionic, high osmolality (2130 mOsm/Kg) contrast agent Ioxitalamato.

Exclusion criteria

• using metformin or nonsteroidal antiinflammatory drugs within the previous 48 hours
• intake of nephrotoxic drugs during the previous seven days
• pregnancy
• lactation
• intravascular administration of an iodinated contrast medium within the previous two days
• emergency catheterization
• pulmonary edema
• acutely decompensate congestive heart failure
• history of serious reactions to iodinated contrast mediums
• renal transplantation
• end-stage renal disease necessitating dialysis

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 4 patient groups, including a placebo group

Intravenous NAC plus saline

Active Comparator group

Description:

Acetylcysteine was given via intravenous bolus at a rate of 150 mg/kg over 60 min immediately before contrast exposure and followed by 50 mg/kg during and for 6 hours after the procedure. Saline (0.9 percent) was given intravenous at a rate of 1 ml/Kg/h over 60 min prior and followed at the same rate during and for the next 6 hours the procedure.

Treatment:

Drug: Intravenous NAC plus saline

Drug: NAC plus saline

Sodium bicarbonate plus saline

Active Comparator group

Description:

Sodium bicarbonate solution (Sodium bicarbonate 8.4%, Equiplex, Brazil) was given by adding fifteen ampoules of sodium bicarbonate (150 mEq of sodium) to 1 L of 5% dextrose. Infusion in bolus began 60 min prior to the start of contrast administration at 3.5 ml/Kg/h, decreased to 1.18 ml/Kg/h during the contrast exposure and for the next 6 hours after the procedure. Saline (0.9 percent) was given IV at a rate of 1 ml/Kg/h over 60 min prior to the start of contrast administration and followed at the same rate during and for the next 6 hours after the procedure.

Treatment:

Drug: Sodium bicarbonate plus saline

NAC plus sodium bicarbonate plus saline

Active Comparator group

Description:

Acetylcysteine was given intravenous at a rate of 150 mg/kg over 60 min before contrast exposure and followed by 50 mg/kg during and for 6 hours after the procedure. Sodium bicarbonate solution (150 mEq/L of sodium) was given in bolus began 60 min before contrast administration at 3.5 ml/Kg/h, decreased to 1.18 ml/Kg/h during and for the next 6 hours of the procedure. Saline was given intravenous at a rate of 1 ml/Kg/h over 60 min prior to the start of contrast administration and followed at the same rate during and for the next 6 hours after the procedure.

Treatment:

Drug: NAC plus sodium bicarbonate plus saline

Drug: NAC plus sodium bicarbonate plus saline

Saline

Placebo Comparator group

Description:

Saline (0.9 percent) was given IV at a rate of 1 ml/Kg/h over 60 min prior to the start of contrast administration and followed at the same rate during and for the next 6 hours after the procedure.

Treatment:

Drug: Saline