Sodium Bicarbonate in Preventing Contrast Induced Nephropathy

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

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2010-05-31

Brief Summary

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We plan to conduct an open-label, randomized, stratified, parallel-group study to compare normal saline infusion to sodium bicarbonate infusion.

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Detailed Description

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We plan to conduct an open-label, randomized, stratified, parallel-group study to compare normal saline infusion to sodium bicarbonate infusion. 220 adult patients scheduled for routine cardiac catheterization will be enrolled. They will stratified according to the presence or absence of DM, or an estimated GER of less than 60 ml/hr before being block-randomized to the two groups. The incidence of CIN will be determined based on the average of two measurements of creatinine level before and 48 hours after the procedure, and an increase of 25% or 0.5 mg/dL (44.2 umol/L) or more.

Conditions

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Contrast Induced Nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

hydration with normal saline

Group Type ACTIVE_COMPARATOR

sodium bicarbonate infusion

Intervention Type OTHER

short infusion of sodium bicarbonate

2

hydration with sodium bicarbonate

Group Type EXPERIMENTAL

sodium bicarbonate infusion

Intervention Type OTHER

short infusion of sodium bicarbonate

Interventions

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sodium bicarbonate infusion

short infusion of sodium bicarbonate

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

All adult patients (18 years and above) who are scheduled for cardiac catechization and have abnormal but stable renal function will be eligible for enrollment. Abnormal renal function is defined as a creatinine level exceeding the normal range (more than 115 or 96 um/L in males and females, respectively, in KFSH\&RC laboratories) or eGFR less than 60 ml/min

Exclusion Criteria

Patients who fall under any of the following categories will be excluded:

* Acute renal failure
* Cardiogenic shock
* Emergency cardiac catheterization
* Preexisting peritoneal or hemodialysis
* Pregnancy
* Recent exposure to contrast agent within the last 3 days
* Allergy to contrast or any of the above treatment
* Renal transplant,
* Patients who received dopamine, mannitol, theophyllin or other medications known to affect renal function within one week from cardiac cath
* Pulmonary edema / congestive heart failure
* Use of N-acetylcystein
* Patents on NSAIDS who can not stop using them for 48 hrs before and 48 hrs after procedure (except Aspirin).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No