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

Sponsor

Ospedale Misericordia e Dolce (Other)

Overall Status

Completed

CT.gov ID

NCT00606827

Collaborator

(none)

500

Enrollment

Location

Arms

13.9

Duration (Months)

35.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Contrast-Induced Nephropathy	Drug: Sodium Bicarbonate Drug: Isotonic Saline	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

500 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jan 1, 2005

Actual Study Completion Date :

Mar 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A 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
Active Comparator: B 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

Arm

Intervention/Treatment

Experimental: A

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

Active Comparator: B

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ospedale Misericordia e Dolce	Prato		Italy	59100

Sponsors and Collaborators

Ospedale Misericordia e Dolce

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mauro Maioli, MD, Ospedale Misericordia e Dolce

ClinicalTrials.gov Identifier:

NCT00606827

Other Study ID Numbers:

Prato0701
POCARD0701

First Posted:

Feb 5, 2008

Last Update Posted:

May 8, 2012

Last Verified:

May 1, 2012

Keywords provided by Mauro Maioli, MD, Ospedale Misericordia e Dolce

Contrast-induced nephrophaty

Contrast media

Angiography

Coronary percutaneous intervention

Additional relevant MeSH terms:

Kidney Diseases

Study Results

No Results Posted as of May 8, 2012