Clinical Trial Details
| Trial ID: | L1114 |
| Source ID: | NCT00930436 |
| Associated Drug: | Sodium Bicarbonate |
| Title: | Evaluation of Sodium Bicarbonate to Reduce the Incidence of Contrast Induced Chronic Kidney Injury in Patients With Kidney Disease |
| Acronym: | BOSS |
| Status: | TERMINATED |
| Study Results: | NO |
| Results: | |
| Conditions: | Contrast Induced Kidney Injury. |
| Interventions: | DRUG: sodium bicarbonate |
| Outcome Measures: | 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 | Secondary: 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 |
| Sponsor/Collaborators: | Sponsor: MD Scientific |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 391 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION |
| Start Date: | 2010-01 |
| Completion Date: | 2012-09 |
| Results First Posted: | |
| Last Update Posted: | 2012-08-23 |
| Locations: | Osceola Regional Medical Center, Kissimmee, Florida, 34741, United States|Northside Hospital, St Petersburg, Florida, 33709, United States|Redmond Regional Medical Center, Rome, Georgia, 30165, United States|St. Johns Hospital, Springfield, Illinois, 62701, United States|Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States|St Luke's Health System, Kansas City, Missouri, 64111, United States|Hackensack University Medical Center, Hackensack, New Jersey, 07601, United States|Mt Sinai School of Medcine, New York, New York, 10029, United States|Stony Brook University Medical Center, Stony Brook, New York, United States|The Christ Hospital, Cincinnati, Ohio, United States|St Luke's Heart and Vascular Center, Bethlehem, Pennsylvania, 18015, United States|Geisinger Medical Center, Danville, Pennsylvania, 17822, United States|Rhode Island Hospital, Providence, Rhode Island, 02903, United States|The Miriam Hospital (Lifespan), Providence, Rhode Island, 02906, United States|Centennial Medical Center, Nashville, Tennessee, 37203, United States|Baylor Heart and Vascular Hospital, Dallas, Texas, 75227, United States|Fletcher Allen Hospital, Burlington, Vermont, 05401, United States |
| URL: | https://clinicaltrials.gov/show/NCT00930436 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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