|
|
|
|
|
|
Sponsored by: |
Ospedale Misericordia e Dolce |
Information provided by: | Ospedale Misericordia e Dolce |
ClinicalTrials.gov Identifier: | NCT00606827 |
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.
Condition | Intervention | Phase |
Contrast-Induced Nephropathy |
Drug: Sodium Bicarbonate Drug: Isotonic Saline |
Phase IV |
Drug Information available for: | Sodium chloride Chlorides Sodium bicarbonate |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Sodium Bicarbonate Versus Saline for the Prevention of Contrast-Induced Nephropathy in Patients Undergoing Coronary Angiography |
Enrollment: | 500 |
Study Start Date: | January 2005 |
Study Completion Date: | March 2006 |
Arms | Assigned Interventions |
A: Experimental
Bicarbonate
|
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
|
B: Active Comparator
Saline
|
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
|
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Cardiology Unit ( Mauro Maioli MD ) |
Study ID Numbers: | Prato0701, POCARD0701 |
First Received: | January 22, 2008 |
Last Updated: | January 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00606827 |
Health Authority: | Italy: National Bioethics Committee |
|
|