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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 is a Phase 2 study that was terminated before completion, run by Barnes-Jewish Hospital. The registered enrollment target is 11 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00575484
The ClinicalTrials.gov registry entry for NCT00575484 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Barnes-Jewish Hospital, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Hypertonic saline, then oral sodium chloride is the first listed.
NCT00575484 reports 0 study locations.
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.
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