Assessing the Renal Consequences and Functional Efficacy of Low Dose Hypertonic Saline Solution and Furosemide for the Treatment of Congestive Heart Failure in a Randomized, Double Blind, Prospective Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Renal function (GFR)
研究概览
简要总结
The purpose of this study is to compare high dose furosemide in combination with low volume hypertonic saline solution (2.4%) with intermittent pulse dose furosemide in patients with pre treatment kidney function impairment. The hypothesis is that it will provide effective diuretic response and have a beneficial effect on preservation of renal function as compared to pulse furosemide in patients with pre-treatment renal impairment (GFR < 60 mL/min).
详细描述
Currently, congestive heart failure (CHF) is the fastest growing heart-related diagnosis in North America, with the chance of a person experiencing it during their lifetime around 20%. In patients with CHF, acute decompensation requiring hospitalizations are common. Patients with renal insufficiency are more susceptible to worsening of renal function or overt renal failure in relation to an episode of decompensated heart failure. Thus, there is a great need for treatment to help patients with renal dysfunction that can simultaneously protect them from further renal deterioration. Preliminary evidence indicates that hypertonic saline solution (HSS) combined with high dose loop diuretics may improve the prognosis for patients with CHF. In two separate studies, this treatment was found to alleviate symptoms of CHF, and significantly reduce hospital length of stay, as well as reduce morbidity and mortality subsequent to hospital stay. So far, available studies have demonstrated that renal function is not compromised when using HSS and high dose furosemide as a treatment for CHF. Preliminary data from our institution suggests that low volume HSS combined with high dose furosemide may be beneficial for patients with renal insufficiency.
Hypothesis
High dose furosemide in combination with low volume HSS provides effective diuretic response and has a beneficial effect on preservation of renal function while in hospital as compared to pulse furosemide in patients with pre-treatment renal impairment (GFR < 60 mL/min).
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
- •Uncompensated CHF
- •Framingham Criteria for HF
- •2 Major or
- •1 Major 2 minor
- •Major criteria:
- •Paroxysmal nocturnal dyspnea
- •Neck vein distention
- •Radiographic cardiomegaly (increasing heart size on chest radiography)
- •Acute pulmonary edema
- •S3 gallop
- •Increased central venous pressure (>16 cm H2O at right atrium)
- •Hepatojugular reflux
- •Weight loss > 4.5 kg in 5 days in response to treatment
- •Minor criteria:
- •Bilateral ankle edema
- •Nocturnal cough
- •Dyspnea on ordinary exertion
- •Hepatomegaly
- •Pleural effusion
- •Decrease in vital capacity by one third from maximum recorded
- •Tachycardia (heart rate>120 beats/min.)
- •No Ejection Fraction Inclusion Criteria
- •GFR £ 60 mL/min
- •GFR (mL/min/1.73 m2) = 186 x (Scr)-1.154 x (Age)-0.203 x (0.742 if female) x (1.212 if African American) (conventional units).
- •Informed consent
排除标准
- •Patients with Acute Coronary Syndrome
- •Post -op patients within 90 days of previous surgery
- •Patients currently on dialysis
- •Hospice patients
- •Patients < 18 years of age.
研究组 & 干预措施
Furosemide with Hypertonic Saline
Furosemide with 150 mL of 2.4% NaCl
干预措施: furosemide and hypertonic saline solution (Drug)
Pulse Furosemide
80-160 mg furosemide (Given over 5 min IV twice a day)
干预措施: furosemide (Drug)
结局指标
主要结局
Renal function (GFR)
时间窗: 30 days
次要结局
- BNP Levels(discharge, 30 days and 6 months)
- Hospitalization cost analysis(30 days)
- Readmission rate(6 months)
- Weight loss(one week)
- Diuretic response (defined as achievement of weight within 2% of previously determined dry body weight or reaching a clinically compensated state including return of functional level to prior NYHA class as determined by the primary treating physician)(one week)
- Length of hospital stay(30 days)
研究者
Karen Olson
Research Manager
Aspirus Heart and Vascular Institute-Research and Education