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NCT00312117 · ClinicalTrials.gov registry record · Phase 3
Trial for Prevention of Contrast Nephropathy With Sodium Bicarbonate
A Phase 3 study, sponsored by Kaiser Permanente.
- Completed
- Registry status
- Phase 3
- Development phase
- 300
- Enrollment target
NCT00312117 is a Phase 3 study that has completed, run by Kaiser Permanente. The registered enrollment target is 300 participants.
The verdict
NCT00312117, a Phase 3 study, has completed, sponsored by Kaiser Permanente.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 300 participants
- Enrollment target
Study Summary
Contrast nephropathy (CN) is a common cause of renal failure associated with prolonged hospitalization, significant morbidity/mortality, and cost. In addition, these patients may require temporary or permanent hemodialysis which, in turn, is associated with further morbidity, mortality, and cost. CN has been reported to account for 10% of hospital acquired renal failure. In recent years, studies have investigated preventive therapies with mixed results. Fenoldopam was found to be ineffective in a large randomized trial. Dopamine has been shown to be ineffective as a preventive strategy. Hemofiltration has been shown to be beneficial (New England Journal of Medicine \[NEJM\] 2003) but is costly and not practical. Mucomyst has shown mixed results. The single strategy which most would agree as being beneficial remains hydration, most commonly with intravenous 0.9% normal saline. Most recently, sodium bicarbonate has been shown to be beneficial in a small randomized trial (n=119). It is clear that the most cost effective strategies for treatment of CN should be aimed at prevention. The general question is: "Is a sodium bicarbonate solution more efficacious in preventing contrast nephropathy compared to normal saline?" The general hypothesis is that sodium bicarbonate will be more efficacious.
Interventions
- DRUG Sodium bicarbonate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2006-01 |
| Est. Completion | 2006-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00312117
The ClinicalTrials.gov registry entry for NCT00312117 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kaiser Permanente, which has 294 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Sodium bicarbonate is the first listed.
NCT00312117 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00312117 about?
NCT00312117 is a clinical study titled "Trial for Prevention of Contrast Nephropathy With Sodium Bicarbonate". Contrast nephropathy (CN) is a common cause of renal failure associated with prolonged hospitalization, significant morbidity/mortality, and cost. In addition, these patients may require temporary or permanent hemodialysis which, in turn, is associated with further morbidity, mortality, and cost. CN...
What is the current status of trial NCT00312117?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 300 participants. The study started on 2006-01. Estimated completion is 2006-02.
What interventions are being tested in trial NCT00312117?
The interventions under investigation include: Sodium bicarbonate (DRUG).
Who is sponsoring clinical trial NCT00312117?
This trial is sponsored by Kaiser Permanente, which has 294 total clinical trials registered on ClinicalTrials.gov.
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