Trial | NCT00930436  Report issue

Title

Evaluation of Sodium Bicarbonate to Reduce the Incidence of Contrast Induced Chronic Kidney Injury in Patients With Kidney Disease
Evaluation of Sodium Bicarbonate to Reduce Chronic Kidney Injury in Subjects With Advanced Chronic Kidney Disease (CKD) Who Are Undergoing Angiography

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    391
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.
Study Started
Jan 31
2010
Primary Completion
Aug 31
2012
Study Completion
Sep 30
2012
Anticipated
Last Update
Aug 23
2012
Estimate

Drug sodium bicarbonate

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

Saline infusion Active Comparator

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.

Sodium Bicarbonate Experimental

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

Criteria 

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
No Results Posted