A Phase 2 interventional study of Hypertonic saline, then oral sodium chloride and Normal saline, then oral placebo capsule in Congestive Heart Failure and Renal Insufficiency, sponsored by Barnes-Jewish Hospital. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-01-24.
Sponsored by Barnes-Jewish Hospital · Phase 2, Interventional, and Treatment
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.
1,994 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.
This study's enrollment of 11 is below the median of 43 across 1,503 interventional studies indexed under Renal Insufficiency.
Browse Renal Insufficiency studies →Barnes-Jewish Hospital is the lead sponsor of 6 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Drug: Normal saline, then oral placebo capsule
Drug: Hypertonic saline, then oral sodium chloride
2mL/kg hypertonic saline (4.4% NaCl if serum sodium \</=135, else 2.8% NaCl) infused over 30min BID and dosed simultaneously with IV bolus furosemide BID (latter dose per treating physician) until patient is switched to oral loop diuretic. After switch to oral diuretic, subject will receive oral 0.75gm sodium (NaCL) capsule dosed BID with loop diuretic (latter dose per treating physician) until 60d after discharge.
20mL normal saline infusion X 30min BID dosed simultaneously with IV bolus furosemide BID (latter dose per treating physician) PLUS 2gm sodium diet PLUS 1.5L fluid restriction. After switch to oral diuretic, begin oral placebo capsule BID, dosed with loop diuretic (dose per treating physician) PLUS 2gm sodium diet PLUS 1.5L fluid restriction.
duration of hospitalization
Time frame: duration of hospitalization
weight loss at discharge
Time frame: duration of hospitalization
weight loss at 60 days
Time frame: 60 days after discharge
number of readmissions
Time frame: 60 days after discharge
GFR by creatinine clearance at discharge
Time frame: duration of hospitalization
estimated GFR at 60 days after discharge
Time frame: 60 days after discharge
24hr urine output at discharge
Time frame: last 24hrs of hospitalization
need for inotrope or extracorporeal volume removal
Time frame: 60 days after discharge
This study is terminated, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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Barnes-Jewish Hospital