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

Primary Purpose

Contrast-Induced Nephropathy

Status

Completed

Phase

Phase 4

Locations

Italy

Study Type

Interventional

Intervention

Sodium Bicarbonate

Isotonic Saline

About this trial

This is an interventional prevention trial for Contrast-Induced Nephropathy focused on measuring Contrast-induced nephrophaty, Contrast media, Angiography, Coronary percutaneous intervention

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Ospedale Misericordia e Dolce

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Bicarbonate

Saline

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00606827

First Posted

January 22, 2008

Last Updated

May 6, 2012

Sponsor

Ospedale Misericordia e Dolce

1. Study Identification

Unique Protocol Identification Number

NCT00606827

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2012

Overall Recruitment Status

Completed

Study Start Date

January 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

March 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ospedale Misericordia e Dolce

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Contrast-Induced Nephropathy

Keywords

Contrast-induced nephrophaty, Contrast media, Angiography, Coronary percutaneous intervention

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

500 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Bicarbonate

Arm Title

Arm Type

Active Comparator

Arm Description

Saline

Intervention Type

Drug

Intervention Name(s)

Sodium Bicarbonate

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Isotonic Saline

Intervention Description

Patients assigned to the isotonic saline group received 1 ml/kg/h 0.9% sodium chloride for 12 hours before and after the procedure

10. Eligibility

Sex

All

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mauro Maioli, MD

Organizational Affiliation

Cardiology Unit - Prato

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ospedale Misericordia e Dolce

City

Prato

ZIP/Postal Code

59100

Country

Italy

12. IPD Sharing Statement

Citations:

PubMed Identifier

18702961

Citation

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.

Results Reference

derived

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

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