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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00930436

Acronym

BOSS

Enrollment

391

Registered

2009-06-30

Start date

2010-01-31

Completion date

2012-09-30

Last updated

2012-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contrast Induced Kidney Injury.

Keywords

chronic kidney disease

Brief summary

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.

Interventions

DRUGsodium bicarbonate

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Death or renal replacement therapy or sustained kidney injury	Over six months following treatment	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.

Secondary

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026