Sodium Bicarbonate Infusion at Low Concentration to Reduce Kidney Insufficiency by Angiographic Non-iodinated Contrast Media

UMIN ID: C000000419

Registered date:16/05/2006

Basic Information

• Health condition(s) or Problem(s) studied: Contrast-Induced Nephropathy
• Date of first enrollment: 2006/05/01
• Target sample size: 500
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

administer 154 mEq/L of sodium bicarbonate intravenously, as a bolus of 3 mL/kg/hr for 1 hour before coronary angiography, followed by an infusion of 1 mL/kg/hr for 6 hours after coronary angiography
administer 0.9% saline intravenously at 1 mL/kg/hr for 12 hours before through 12 hours after coronary angiography

Outcome(s)

• Primary Outcome: the incidence of contrast-induced nephropathy within 2 days of coronary angiography
• Secondary Outcome: the incidence of adverse events, the change of glomerular filtration rate in one year and the occurrence of clinical events within one year of coronary angiography

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: individuals with preexisting dialysis, anticipated dialysis after coronary angiography, acute coronary syndrome, emergency catheterization, overt congestive heart failure, administration of contrast within the previous 3 days and anticipated readministration of contrast following 3 days

Related Information

• Primary Sponsor: Department of Cardiovascular Medicine, Kyoto University Hospital
• Source(s) of Monetary Support: none