Contrast Induced Kidney Injury. Clinical Trial
— BOSSOfficial title:
Evaluation of Sodium Bicarbonate to Reduce Chronic Kidney Injury in Subjects With Advanced Chronic Kidney Disease (CKD) Who Are Undergoing Angiography
| Verified date | February 2012 |
| Source | MD Scientific |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 391 |
| Est. completion date | September 2012 |
| Est. primary completion date | August 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| United States | St Luke's Heart and Vascular Center | Bethlehem | Pennsylvania |
| United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
| United States | Fletcher Allen Hospital | Burlington | Vermont |
| United States | The Christ Hospital | Cincinnati | Ohio |
| United States | Baylor Heart and Vascular Hospital | Dallas | Texas |
| United States | Geisinger Medical Center | Danville | Pennsylvania |
| United States | Hackensack University Medical Center | Hackensack | New Jersey |
| United States | St Luke's Health System | Kansas City | Missouri |
| United States | Osceola Regional Medical Center | Kissimmee | Florida |
| United States | Centennial Medical Center | Nashville | Tennessee |
| United States | Mt Sinai School of Medcine | New York | New York |
| United States | Rhode Island Hospital | Providence | Rhode Island |
| United States | The Miriam Hospital (Lifespan) | Providence | Rhode Island |
| United States | Redmond Regional Medical Center | Rome | Georgia |
| United States | St. Johns Hospital | Springfield | Illinois |
| United States | Northside Hospital | St Petersburg | Florida |
| United States | Stony Brook University Medical Center | Stony Brook | New York |
| Lead Sponsor | Collaborator |
|---|---|
| MD Scientific |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Yes |
| Secondary | A comparison between the treatments for length of hospital stay, post contrast. | Over six months after the treatment | No | |
| Secondary | 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 | Yes |