Sodium Bicarbonate Versus Saline for the Prevention of Contrast-induced Nephropathy

• ClinicalTrials.gov Identifier: NCT00606827
• Recruitment Status: Completed
• First Posted: February 5, 2008
• Last Update Posted: May 8, 2012
• Sponsor: Ospedale Misericordia e Dolce
• Information provided by (Responsible Party): Mauro Maioli, Ospedale Misericordia e Dolce

Tracking Information

• First Submitted Date: January 22, 2008
• First Posted Date: February 5, 2008
• Last Update Posted Date: May 8, 2012
• Study Start Date: January 2005
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Sodium Bicarbonate Versus Saline for the Prevention of Contrast-induced Nephropathy
• Official Title: Sodium Bicarbonate Versus Saline for the Prevention of Contrast-induced Nephropathy in Patients Undergoing Coronary Angiography
• Brief Summary: Contrast-induced nephrophaty (CIN) accounts for more than 10% of hospital-acquired renal failure. Hydration with sodium bicarbonate is more protective than isotonic saline in animals. Limited data are available in humans. We compared the efficacy of sodium bicarbonate versus isotonic saline to prevent CIN in a large population of patients with renal dysfunction undergoing coronary angiography or intervention.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: Contrast-Induced Nephropathy

Intervention

• Drug: Sodium Bicarbonate
  Patients in the sodium bicarbonate group (154 mEq/L) received 3 ml/kg for 1 hour before contrast medium, followed by an infusion of 1 ml/kg/h for 6 hours after the procedure
• Drug: Isotonic Saline
  Patients assigned to the isotonic saline group received 1 ml/kg/h 0.9% sodium chloride for 12 hours before and after the procedure

Study Arms

• Experimental: A
  Bicarbonate
  Intervention: Drug: Sodium Bicarbonate
• Active Comparator: B
  Saline
  Intervention: Drug: Isotonic Saline

• Publications *: Maioli M, Toso A, Leoncini M, Gallopin M, Tedeschi D, Micheletti C, Bellandi F. Sodium bicarbonate versus saline for the prevention of contrast-induced nephropathy in patients with renal dysfunction undergoing coronary angiography or intervention. J Am Coll Cardiol. 2008 Aug 19;52(8):599-604. doi: 10.1016/j.jacc.2008.05.026.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 22, 2008): 500
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: March 2006
• Primary Completion Date: Not Provided

Eligibility Criteria

Inclusion Criteria:

• patients with creatinine clearance < 60 mL/min

Exclusion Criteria:

• contrast medium administration within the previous 10 days
• end-stage renal failure requiring dialysis
• refusal to give informed consent

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT00606827
• Other Study ID Numbers: Prato0701; POCARD0701
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Mauro Maioli, Ospedale Misericordia e Dolce
• Study Sponsor: Ospedale Misericordia e Dolce
• Collaborators: Not Provided

Investigators

• Principal Investigator: Mauro Maioli, MD; Cardiology Unit - Prato

• PRS Account: Ospedale Misericordia e Dolce
• Verification Date: May 2012