Clinical trial NCT00930436: Evaluation of Sodium Bicarbonate to Reduce the Incidence of Contrast Induced Chronic Kidney Injury in Patients With Kidney Disease
Official title: Evaluation of Sodium Bicarbonate to Reduce Chronic Kidney Injury in Subjects With Advanced Chronic Kidney Disease (CKD) Who Are Undergoing Angiography
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Contrast Induced Kidney Injury.
Keywords: chronic kidney disease
Lead sponsor: MD Scientific
Sponsor class: INDUSTRY
First posted: 2009-06-30
Enrollment: 391
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Death or renal replacement therapy or sustained kidney injury
timeFrame: Over six months following treatment
Secondary outcomes:
measure: A comparison between the treatments for length of hospital stay, post contrast.
timeFrame: Over six months after the treatment
measure: 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.
timeFrame: six months after receiving IP
Other outcomes:
Locations:
city: Kissimmee
country: United States
facility: Osceola Regional Medical Center
state: Florida
city: St Petersburg
country: United States
facility: Northside Hospital
state: Florida
city: Rome
country: United States
facility: Redmond Regional Medical Center
state: Georgia
city: Springfield
country: United States
facility: St. Johns Hospital
state: Illinois
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Kansas City
country: United States
facility: St Luke's Health System
state: Missouri
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New York
country: United States
facility: Mt Sinai School of Medcine
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Bethlehem
country: United States
facility: St Luke's Heart and Vascular Center
state: Pennsylvania
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Providence
country: United States
facility: The Miriam Hospital (Lifespan)
state: Rhode Island
city: Nashville
country: United States
facility: Centennial Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Baylor Heart and Vascular Hospital
state: Texas
city: Burlington
country: United States
facility: Fletcher Allen Hospital
state: Vermont
Study officials:
References: