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Concentrated Saline Infusions and Increased Dietary Sodium With Diuretics for Heart Failure With Kidney Dysfunction
This study has been terminated.
Study NCT00575484   Information provided by Barnes-Jewish Hospital Foundation
First Received: December 17, 2007   Last Updated: September 2, 2009   History of Changes

December 17, 2007
September 2, 2009
November 2007
July 2010   (final data collection date for primary outcome measure)
  • duration of hospitalization [ Time Frame: duration of hospitalization ] [ Designated as safety issue: No ]
  • weight loss at discharge [ Time Frame: duration of hospitalization ] [ Designated as safety issue: No ]
  • weight loss at 60 days [ Time Frame: 60 days after discharge ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00575484 on ClinicalTrials.gov Archive Site
  • number of readmissions [ Time Frame: 60 days after discharge ] [ Designated as safety issue: No ]
  • GFR by creatinine clearance at discharge [ Time Frame: duration of hospitalization ] [ Designated as safety issue: No ]
  • estimated GFR at 60 days after discharge [ Time Frame: 60 days after discharge ] [ Designated as safety issue: No ]
  • 24hr urine output at discharge [ Time Frame: last 24hrs of hospitalization ] [ Designated as safety issue: No ]
  • need for inotrope or extracorporeal volume removal [ Time Frame: 60 days after discharge ] [ Designated as safety issue: No ]
Same as current
 
Concentrated Saline Infusions and Increased Dietary Sodium With Diuretics for Heart Failure With Kidney Dysfunction
Hypertonic Saline With Furosemide and a Normosodic Diet for the Treatment of Decompensated Congestive Heart Failure With Prerenal Physiology

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.

 
Phase II
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
  • Congestive Heart Failure
  • Renal Insufficiency
  • Drug: Hypertonic saline, then oral sodium chloride
  • Drug: Normal saline, then oral placebo capsule
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Terminated
60
July 2010
July 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients (age ≥18) admitted with CHF exacerbation with NYHA Class III-IV symptoms at screening.
  • Left ventricular ejection fraction </= 45%, as determined by previous echocardiogram, left ventricular angiogram, or thallium myocardial imaging.
  • Estimated GFR <60 ml/min/1.7m² with significant prerenal physiology as judged by prior documented volume mediated changes in renal function, a fractional excretion of urea <35%, or a fractional excretion of sodium <1%. For GFR 30-60: must have serum sodium </= 135 mEq/L OR large home diuretic dose (total daily loop diuretic dose >/= 120 mg/d in furosemide equivalents OR concomitant thiazide use). For GFR <30: no additional criteria needed.

Exclusion Criteria:

  • Admit estimated GFR < 15mL/min or predicted need for chronic hemodialysis within the next 60 days.
  • Cause of acute kidney injury other than prerenal physiology.
  • No loop diuretic prior to admission or loop diuretic initiated within the 2 wks prior to admission.
  • Medicine or dietary noncompliance expected to prevent successful study participation.
  • > 36hrs since presentation to screening.
  • Serum Na > 145 mEq/L OR < 120 mEq/L at screening.
  • Systolic blood pressure > 180 mmHg at screening.
  • Presentation with acute coronary syndrome OR left heart catheterization planned at screening.
  • Current or impending respiratory failure at screening.
  • Current calcineurin inhibitor or nesiritide use.
  • Nephrotic-range proteinuria.
  • Clinical evidence for the presence of cirrhosis with bilirubin >/= 2mg/dL or international normalized ratio (not on coumadin) >/= 1.7.
  • Presence of another active medical issue which may prolong hospital admission or delay aggressive CHF therapy.
  • Participation in another interventional study.
  • Pregnancy.
  • Prisoners.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00575484
Anitha Vijayan, Associate Professor of Medicine, Washington University School of Medicine
00904-0407-01
Barnes-Jewish Hospital Foundation
National Kidney Foundation
Principal Investigator: Anitha Vijayan, M.D. Renal Division, Washington University School of Medicine
Principal Investigator: Kamalanathan K Sambandam, M.D. Renal Division, Washington University School of Medicine
Principal Investigator: Gregory A Ewald, M.D. Cardiovascular Division, Washington University School of Medicine
Barnes-Jewish Hospital Foundation
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP