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Sodium Bicarbonate for Prevention of Contrast-Induced Nephropathy

Primary Purpose

Renal Failure

Status

Completed

Phase

Phase 3

Locations

Brazil

Study Type

Interventional

Intervention

sodium bicarbonate

saline

About this trial

This is an interventional prevention trial for Renal Failure focused on measuring contras-induced nephropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

serum creatinine > 1.1 mg/dL
glomerular filtration rate (GFR) < 50 mL/min

Exclusion Criteria:

age < 18 years
use of radiographic contrast media during the last 21 days
history of dialysis
cardiac insufficiency class III-IV
emergency procedures

Sites / Locations

São Lucas Hospital - PUCRS University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

sodium bicarbonate

saline

Arm Description

hydration with sodium bicarbonate

hydration with saline 1ml/Kg/h for 6 hours

Outcomes

Primary Outcome Measures

Contrast-induced Nephropathy

rise in serum creatinine >0,5mg/dl

Secondary Outcome Measures

Dialysis During Hospitalization

Full Information

NCT ID

NCT01172353

First Posted

July 28, 2010

Last Updated

January 7, 2014

Sponsor

Hospital Sao Lucas da PUCRS

1. Study Identification

Unique Protocol Identification Number

NCT01172353

Brief Title

Sodium Bicarbonate for Prevention of Contrast-Induced Nephropathy

Official Title

Hydration With Sodium Bicarbonate for Prevention of Contrast-Induced Nephropathy: A Multicenter Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

July 2004 (undefined)

Primary Completion Date

January 2008 (Actual)

Study Completion Date

February 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital Sao Lucas da PUCRS

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to determine whether hydration with sodium bicarbonate is superior to hydration with saline to prevent contrast-induced nephropathy.

6. Conditions and Keywords

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

Renal Failure

Keywords

contras-induced nephropathy

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

301 (Actual)

8. Arms, Groups, and Interventions

Arm Title

sodium bicarbonate

Arm Type

Experimental

Arm Description

hydration with sodium bicarbonate

Arm Title

saline

Arm Type

Active Comparator

Arm Description

hydration with saline 1ml/Kg/h for 6 hours

Intervention Type

Drug

Intervention Name(s)

sodium bicarbonate

Intervention Description

hydration with sodium bicarbonate 1ml/Kg/h for 6 hours

Intervention Type

Drug

Intervention Name(s)

saline

Intervention Description

hydration with saline 1ml/Kg/h for 6 hours

Primary Outcome Measure Information:

Title

Contrast-induced Nephropathy

Description

rise in serum creatinine >0,5mg/dl

Time Frame

48 hours

Secondary Outcome Measure Information:

Title

Dialysis During Hospitalization

Time Frame

During hospitalization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: serum creatinine > 1.1 mg/dL glomerular filtration rate (GFR) < 50 mL/min Exclusion Criteria: age < 18 years use of radiographic contrast media during the last 21 days history of dialysis cardiac insufficiency class III-IV emergency procedures

Facility Information:

Facility Name

São Lucas Hospital - PUCRS University

City

Porto Alegre

State/Province

ZIP/Postal Code

90610-000

Country

Brazil

12. IPD Sharing Statement

Learn more about this trial

Sodium Bicarbonate for Prevention of Contrast-Induced Nephropathy

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