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NCT00575484 · ClinicalTrials.gov registry record · Phase 2
Concentrated Saline Infusions and Increased Dietary Sodium With Diuretics for Heart Failure With Kidney Dysfunction
A Phase 2 study, sponsored by Barnes-Jewish Hospital.
- Terminated
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
NCT00575484: Clinical Trial Phase 2 study, sponsored by Barnes-Jewish Hospital.
NCT00575484 is a Phase 2 study that was terminated before completion, run by Barnes-Jewish Hospital. The registered enrollment target is 11 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00575484, a Phase 2 study, was terminated before completion, sponsored by Barnes-Jewish Hospital.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 11 participants
- Enrollment target
Study Summary
At present the standard management of fluid overload in patients with congestive heart failure (CHF) involves limiting the intake of salt and water while administering high dose diuretics, often at the cost of deteriorating kidney function. However, another group of researchers has previously shown that intravenously infusing small volumes of concentrated saline during diuretic dosing and liberalizing dietary salt intake while continuing to limit water consumption resulted in improved fluid removal in CHF patients. Furthermore, less deterioration in kidney function, shorter hospitalizations, reduced readmission rates, and even reduced mortality were observed. The present study will examine this novel therapy in a population of 60 patients with underlying severe CHF and kidney dysfunction hospitalized for the management of fluid overload. Half of these patients will receive investigational treatment with concentrated salt infusions and liberalized salt consumption during diuretic therapy. All patients will otherwise receive the standard therapies for heart failure, including restrictions on water consumption. This study will attempt to verify the improvements in clinical endpoints previously described and define the mechanisms of enhanced fluid removal.
Interventions
- DRUG Hypertonic saline, then oral sodium chloride
- DRUG Normal saline, then oral placebo capsule
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2007-11 |
| Est. Completion | 2008-07 |
| Phase | Phase 2 |
Why NCT00575484 stopped before completion
NCT00575484 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Hypertonic saline, then oral sodium chloride is the first listed.
NCT00575484 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00575484 about?
NCT00575484 is a clinical study titled "Concentrated Saline Infusions and Increased Dietary Sodium With Diuretics for Heart Failure With Kidney Dysfunction". At present the standard management of fluid overload in patients with congestive heart failure (CHF) involves limiting the intake of salt and water while administering high dose diuretics, often at the cost of deteriorating kidney function. However, another group of researchers has previously shown ...
What is the current status of trial NCT00575484?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2007-11. Estimated completion is 2008-07.
What interventions are being tested in trial NCT00575484?
The interventions under investigation include: Hypertonic saline, then oral sodium chloride (DRUG), Normal saline, then oral placebo capsule (DRUG).
Who is sponsoring clinical trial NCT00575484?
This trial is sponsored by Barnes-Jewish Hospital, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00575484's enrollment target sits among peer trials
11 1967th of 2000 higher than 33 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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