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

Study Overview
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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.

Official Title
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Evaluation of Sodium Bicarbonate to Reduce Chronic Kidney Injury in Subjects With Advanced Chronic Kidney Disease (CKD) Who Are Undergoing Angiography

Conditions
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Contrast Induced Kidney Injury.

Intervention / Treatment
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* Drug: sodium bicarbonate


Participation Criteria
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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

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Saline infusion<br>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. | Drug: sodium bicarbonate<br>* Serum creatinine will be measured on Days 3,7, 30, 90, and 180<br>|
| Experimental: Sodium Bicarbonate<br>Infusion of sodium bicarbonate will be given prior to,during and after the contrast agent for a total of 6 to 10 hours | Drug: sodium bicarbonate<br>* Serum creatinine will be measured on Days 3,7, 30, 90, and 180<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death or renal replacement therapy or sustained kidney injury | Sustained kidney injury is two sequential 20% reduction of eGFR from baseline as calculated from change in sertum creatinine at least three weeks after receiving IP. | Over six months following treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A comparison between the treatments for length of hospital stay, post contrast. |  | Over six months after the treatment | 
| A comparison between the treatments of the time to renal replacement therapy (any type) or death (whichever occurs first) over the 6-month observation period. |  | six months after receiving IP | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic kidney disease