Hypertonic Saline With Furosemide and a Normosodic Diet for the Treatment of Decompensated Congestive Heart Failure With Prerenal Physiology
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- weight loss at 60 days
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •Presence of another active medical issue which may prolong hospital admission or delay aggressive CHF therapy.
- •Participation in another interventional study.
- •Pregnancy.
- •Prisoners.
研究组 & 干预措施
1
干预措施: Normal saline, then oral placebo capsule (Drug)
2
干预措施: Hypertonic saline, then oral sodium chloride (Drug)
结局指标
主要结局
weight loss at 60 days
时间窗: 60 days after discharge
duration of hospitalization
时间窗: duration of hospitalization
weight loss at discharge
时间窗: duration of hospitalization
次要结局
- number of readmissions(60 days after discharge)
- GFR by creatinine clearance at discharge(duration of hospitalization)
- estimated GFR at 60 days after discharge(60 days after discharge)
- 24hr urine output at discharge(last 24hrs of hospitalization)
- need for inotrope or extracorporeal volume removal(60 days after discharge)
研究者
Anitha Vijayan, MD
Professor of Medicine
Washington University School of Medicine