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

MD Scientific

Status and phase: Terminated; Phase 3

Conditions: Contrast Induced Kidney Injury.

Treatments: Drug: sodium bicarbonate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00930436

MDS001

Details and patient eligibility

About

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.

Enrollment: 391 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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391 participants in 2 patient groups

Saline infusion

Active Comparator group

Description:

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.

Treatment:

Drug: sodium bicarbonate

Sodium Bicarbonate

Experimental group

Description:

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

Treatment:

Drug: sodium bicarbonate