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Evaluation of Sodium Bicarbonate to Reduce the Incidence of Contrast Induced Chronic Kidney Injury in Patients With Kidney Disease

NCT ID: NCT00930436

Last Updated: 2012-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

391 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-09-30

Brief Summary

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Patients with Stage 3B, 4,or 5 Chronic Kidney Disease who are to undergo an angiography procedure with contrast agent will be asked if they are willing to join the trial. If so they will be screened and randomized to receive either sodium bicarbonate or saline before, during and after the contrast media is given. They will be asked for serum samples 1 to 3 days, 7, 30, 90 and 180 days after the procedure to evaluate whether the sodium bicarbonate has reduced the incidence of contrast induced chronic kidney disease by measuring their serum creatinine, as well as whether they have required renal dialysis or other renal replacement therapy.

Detailed Description

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Conditions

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Contrast Induced Kidney Injury.

Keywords

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chronic kidney disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Saline infusion

Saline will be given as an active control agent to compare with sodium bicarbonate. Each bag of solution will be blinded, and given in the same manner.

Group Type ACTIVE_COMPARATOR

sodium bicarbonate

Intervention Type DRUG

Serum creatinine will be measured on Days 3,7, 30, 90, and 180

Sodium Bicarbonate

Infusion of sodium bicarbonate will be given prior to,during and after the contrast agent for a total of 6 to 10 hours

Group Type EXPERIMENTAL

sodium bicarbonate

Intervention Type DRUG

Serum creatinine will be measured on Days 3,7, 30, 90, and 180

Interventions

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sodium bicarbonate

Serum creatinine will be measured on Days 3,7, 30, 90, and 180

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Candidate for angiography
* Stage 3B, 4 or 5 Chronic kidney disease (i.e. eGFR \<=44)
* Either sex over 18 years of age

Exclusion Criteria

* Pregnant or breast feeding
* On any kidney replacement list
* Gastric tube in place or gastric drainage
* Uncorrected hypoglycemia
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MD Scientific

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Osceola Regional Medical Center

Kissimmee, Florida, United States

Site Status

Northside Hospital

St. Petersburg, Florida, United States

Site Status

Redmond Regional Medical Center

Rome, Georgia, United States

Site Status

St. Johns Hospital

Springfield, Illinois, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

St Luke's Health System

Kansas City, Missouri, United States

Site Status

Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status

Mt Sinai School of Medcine

New York, New York, United States

Site Status

Stony Brook University Medical Center

Stony Brook, New York, United States

Site Status

The Christ Hospital

Cincinnati, Ohio, United States

Site Status

St Luke's Heart and Vascular Center

Bethlehem, Pennsylvania, United States

Site Status

Geisinger Medical Center

Danville, Pennsylvania, United States

Site Status

Rhode Island Hospital

Providence, Rhode Island, United States

Site Status

The Miriam Hospital (Lifespan)

Providence, Rhode Island, United States

Site Status

Centennial Medical Center

Nashville, Tennessee, United States

Site Status

Baylor Heart and Vascular Hospital

Dallas, Texas, United States

Site Status

Fletcher Allen Hospital

Burlington, Vermont, United States

Site Status

Countries

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United States

Other Identifiers

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MDS001

Identifier Type: -

Identifier Source: org_study_id