Sodium Bicarbonate in Preventing Contrast Induced Nephropathy

Study Overview
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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.

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.

Official Title
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Sodium Bicarbonate in Preventing Contrast Induced Nephropathy (SIPCIN): A Randomized Controlled Study

Conditions
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Contrast Induced Nephropathy

Intervention / Treatment
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* Other: sodium bicarbonate infusion


Participation Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>hydration with normal saline | Other: sodium bicarbonate infusion<br>* short infusion of sodium bicarbonate<br>|
| Experimental: 2<br>hydration with sodium bicarbonate | Other: sodium bicarbonate infusion<br>* short infusion of sodium bicarbonate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Contrast Induced nephropathy |  | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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contrast-induced-nephropathy,, cardiac cath, creatinine, contrast, nephropathy