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Prevention of Contrast Induced Nephropathy With Sodium Bicarbonate

NCT ID: NCT00472563

Last Updated: 2008-05-06

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

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

212 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2008-02-29

Brief Summary

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Deterioration of kidney renal function occurs in a minority of people due to contrast-required procedures. The purpose of this study is to compare two different interventions to reduce the risk of kidney injury after contrast medium exposition.

We will perform a randomized clinical trial following a modification of a previously published protocol (Merten et al.JAMA 2004;291(19):2328-34). Patients will be randomly assigned to one of two groups of treatment. Group A will receive 1 cc/kg/hour of 0.9% saline infusion starting 12 hours before and continuing 12 hours after the procedure. Group B will receive 3 cc/kg of sodium bicarbonate solution for one hour prior to procedure, then drip rate will be decreased to 1 cc/kg/hour until 6 hours post procedure.

Detailed Description

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We will perform a randomized clinical trial following a modification of a previously published protocol (Merten et al.JAMA 2004;291(19):2328-34). Patients will be randomly assigned to one of two groups of treatment. Group A will receive 1 cc/kg/hour of 0.9% saline infusion starting 12 hours before and continuing 12 hours after the procedure. Group B will receive 3 cc/kg of sodium bicarbonate solution for one hour prior to procedure, then drip rate will be decreased to 1 cc/kg/hour until 6 hours post procedure.

Phase 2/3 study Study Type: Interventional Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study.

Subjects: Consecutive samples of all inpatients who meet the inclusion criteria

Primary outcomes: Development of contrast induced nephropathy, defined as an increase in serum creatinine of 25% or more within 48 h after administration of contrast.

Secondary outcomes: change in serum bicarbonate; change in serum potassium; change in serum creatinine.

Expected total enrollment: 212

Allocation Assignment: Patients who meet inclusion criteria and agree to participate in the study will be assigned by a random number table to saline or bicarbonate, using closed envelopes and stratifying according to history of diabetes and type of procedure (cardiac catheterism or others).

Condition: Contrast Induced Nephropathy

Intervention: 75 cc of sodium bicarbonate (8.4%) mixed in 425 cc of D5W

Gender: both Age: 18+ years of age Recruitment Status: participants are currently being recruited

Facility location:

Universidad de Antioquia, Internal Medicine Department; Hospital Universitario San Vicente de Paul. Medellin, Colombia.

Conditions

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Acute Kidney Failure

Keywords

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bicarbonate nephropathy contrast

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Interventions

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Bicarbinate 150 mEq/L

75 cc of sodium bicarbonate (8.4%) mixed in 425 cc of D5W

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 18+ years of age
* Inpatient at Hospital Universitario San Vicente de Paúl scheduled to undergo diagnostic CT scan using contrast or angiography and either

* Serum creatinine 1.2 mg/dl or more, or
* Type 2 Diabetes Mellitus

Exclusion Criteria

* Current clinical diagnosis of exacerbated congestive heart failure
* Exposure to contrast 30 days prior to study
* Allergy to contrast dye
* Chronic renal disease with dialysis therapy
* Acute renal failure with dialytic urgency
* Urgency procedure needed
* Systolic blood pressure \< 90 or vasopressor support
* No authorization by patient or physician in charge
* Serum potassium \< 3 mEq/L
* Ejection fraction \< 35% by previous echocardiography
* Acute pulmonary edema in previous 48 hours
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad de Antioquia

OTHER

Sponsor Role lead

Principal Investigators

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Wilmar A Maya Salazar, MD

Role: PRINCIPAL_INVESTIGATOR

Universidad de Antioquia

Julián M Aristizábal, MD

Role: STUDY_CHAIR

Universidad de Antioquia

Oscar M Santos, MD

Role: STUDY_CHAIR

Universidad de Antioquia

John F Nieto, MD

Role: STUDY_CHAIR

Universidad de Antioquia

Liliana Jaramillo, MD

Role: STUDY_CHAIR

Universidad de Antioquia

Jorge I García, MD

Role: STUDY_CHAIR

Universidad de Antioquia

Fabian A Jaimes, MD

Role: STUDY_DIRECTOR

Universidad de Antioquia

Alvaro García, MD

Role: STUDY_CHAIR

Universidad de Antioquia

Locations

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Hospital Universitario San Vicente Paúl

Medellín, Antioquia, Colombia

Site Status

Countries

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Colombia

Other Identifiers

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065-120606

Identifier Type: -

Identifier Source: org_study_id