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NCT00606827 Clinical Trial

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

Contrast-Induced Nephropathy Clinical Trial

Official title:
Sodium Bicarbonate Versus Saline for the Prevention of Contrast-induced Nephropathy in Patients Undergoing Coronary Angiography

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00606827
Other study ID # Prato0701
Secondary ID POCARD0701
Status Completed
Phase Phase 4
First received January 22, 2008
Last updated May 6, 2012
Start date January 2005
Est. completion date March 2006

Study information
Verified date May 2012
Source Ospedale Misericordia e Dolce
Contact n/a
Is FDA regulated No
Health authority Italy: National Bioethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 500
Est. completion date March 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

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
• 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

Locations
Country Name City State
Italy Ospedale Misericordia e Dolce Prato

Sponsors (1)
Lead Sponsor Collaborator
Ospedale Misericordia e Dolce

Country where clinical trial is conducted

Italy, 

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