Efficacy and Safety of Ambulatory Hypertonic Saline Therapy in Outpatient Heart Failure Units.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 167
- 试验地点
- 14
- 主要终点
- Diuresis volume (ml)
研究概览
简要总结
The purpose of this study is to compare intravenous furosemide (125 to 250 mg), isolated or in combination with hypertonic saline solution (2.6% to 3.4%) in the outpatient heart failure patient. The hypothesis is that the combination therapy will increase the diuresis volume at 3 hours and improve congestion parameters at 7 days.
详细描述
This is a randomized, double-blind, multicenter study of all consecutive patients with decompensated heart failure and signs of volume overload who do not require hospital admission but require intravenous diuretic for relief of congestion.
Patients meeting the inclusion criteria, with prior informed consent, will be randomized to treatment with furosemide with hypertonic saline versus isolated furosemide (control group).
Complete clinical evaluation, echocardiography, and blood and urinary tests will be performed before the treatment. After 3 hours, diuresis volume, weight and urinary parameters will be evaluated. Efficacy and safety visits will be performed at 7 and 30 days.
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)
盲法说明
Based on an automated online system, blinded to the physicians who evaluated the patient.
Randomization was performed by a trained nurse in a separate room
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
- •Previous heart failure diagnosis (according to current European Guidelines)
- •Stable treatment in the previous 4 weeks (except diuretic).
- •Home oral treatment of ≥80 mg of furosemide/day or equivalent (40 mg furosemide = 20 mg of torasemide).
- •Transthoracic echocardiogram performed in the last year.
- •Congestive signs.The presence of two of the following congestion criteria will be required: jugular pressure> 10 cm, lower limb edema, ascites, or pleural effusion
- •Elevation of natriuretic peptides (NTproBNP> 1000 pg / mL or B-type natriuretic peptide> 250 pg / ml) performed in a previous period of no more than 24 hours.
- •Need for intravenous diuretic therapy to relieve congestion according to the responsible physician.
排除标准
- •Hospital admission criteria in the opinion of the responsible physician.
- •Systolic blood pressure <90 mmHg or> 180 mmHg.
- •Heart rate> 150 bpm or < 40 bpm
- •Basal oxygen saturation less than 90%.
- •Cardiogenic shock.
- •Acute Pulmonary Edema.
- •Clinically significant arrhythmia.
- •Acute myocardial ischemia.
- •Patients in hemodialysis or peritoneal dialysis program.
- •Serum sodium <125 milliequivalent / L or> 145 milliequivalent / L.
- •Serum potassium < 3.5 milliequivalent/ L.
- •Hemoglobin < 9 g / dL
- •Acute coronary syndrome or cardiological procedure in the previous 2 weeks.
- •Severe uncorrected valve disease except tricuspid regurgitation.
- •Moderate or severe dementia, active delirium or psychiatric problems.
- •Patients in whom cardiac surgery or device implantation is planned in the following 30 days.
- •Pregnancy or breastfeeding.
- •Inability to give informed consent in the absence of a legal officer.
- •Patients on tolvaptan.
- •Inability to collect the urine.
研究组 & 干预措施
Intravenous furosemide
干预措施: Intravenous furosemide (Drug)
Hypertonic saline solution plus intravenous furosemide
干预措施: Hypertonic saline solution plus intravenous furosemide (Drug)
结局指标
主要结局
Diuresis volume (ml)
时间窗: 3 hours after treatment
Total diuresis volume after 3 hours of therapy administration
次要结局
- Weight difference (kg)(7 days)
- Change in composite congestion score(7 days)
- Change in Inferior cava vein diameter (mm)(7 days)
- Change in Number of fields with more than 3 B-lines in lung ultrasound(7 days)
- Change in New York Heart Association and Visual Analogue Scale(7 days)
- Change in NTproBNP and Cancer Antigen 125 levels(7 days)
- Change in Hemoconcentration Parameters(7 days)
- Change in Urinary Sodium(7 days)
- Adverse Events(30 days)
研究者
Marta Cobo Marcos
Cardiologist
Puerta de Hierro University Hospital