Prospective Analysis Between Acetazolamide vs Placebo in Patients With Acute Heart Failure
试验速览
- 阶段
- 3 期
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- diuresis and negative water balance
研究概览
简要总结
Introduction: Recent studies have suggested that the use of acetazolamide may assist in the vol- ume management of patients with decompensated heart failure (HF). However, prospective and randomized comparison in patients with HF and optimized diuretic therapy has not been described. Objective: The aim of this study was to evaluate the effectiveness and safety of the use of acetazolamide versus placebo in volume control in patients with decompensated HF. Methodology: For this, a unicentric, randomized, double blind and prospective study will be performed in a comparative manner. Hospital data (test results, medical outcomes, drug dose, complications) of patients will be analyzed for safety and effectiveness. Expected results: The use of acetazolamide as an adjuvant treatment is superior to the standard strategy for volume control in patients with decompensated HF.
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 men and women aged> 18 years.
- •Patients with LVEF ≤ 40% documented on echocardiography
- •BNP> 500 pg / mL
- •Signed consent form.
排除标准
- •Pregnancy
- •Hepatical cirrhosis
- •Known allergy to acetazolamide
- •2nd or 3rd degree atrioventricular block.
- •SBP <90 mmHg or need for vasopressor / inotropic use.
- •Body mass index greater than 40 kg / m
- •Acute coronary syndrome.
- •Orotracheal intubation.
- •Presence of significant pericardial effusion.
- •Left ventricular outflow tract obstruction.
- •Serum creatinine> 5.0 mg / dL, creatinine clearance <10 mL / min or hemodialysis.
- •Presence of 2 or more clinical / laboratory / radiological criteria of infection defined by:
- •Leukocyte> 12,000 / mm3 or> 10% of young forms,
- •Productive cough
- •Bacteremia
- •Inflammatory / infectious skin lesions
- •Abdominal pain with signs of peritonitis
- •Radiological image of pneumonia.
研究组 & 干预措施
Acetazolamide
All patients will receive an initial dose of intravenous furosemide of 1mg / kg, subsequently descaled to 0.5mg / kg of 6 / 6h, associated with oral hydrochlorothiazide 25mg / day and spironolactone 25mg / day orally. When the patient is randomized to the acetazolamide group, he / she will start using the adjuvant medication as acetazolamide drug capsule at the daily dose of 250 mg / day (oral) during the first three days of treatment.
干预措施: Acetazolamide (Drug)
Placebo
All patients will receive an initial dose of intravenous furosemide of 1mg / kg, subsequently descaled to 0.5mg / kg of 6 / 6h, associated with oral hydrochlorothiazide 25mg / day and spironolactone 25mg / day orally. When the patient is randomized to the placebo group, he / she will start using the placebo drug capsule during the first three days of treatment.
干预措施: Placebo (Drug)
结局指标
主要结局
diuresis and negative water balance
时间窗: 72 hours
The comparison between groups for diuresis and negative water balance
次要结局
- Number of cases with acetazolamide side effects(72 hours)
- Level of bicarbonate(30 days)
- Level of BNP(30 days)
- Number of cases with arrhythmia(72 hours)
- Number of cases with circulatory assistance(72 hours)
- Number of cases with worsening of renal function(72 hours)
- Number of cases with lowering of consciousness level(72 hours)
- Number of cases with vasopressor(72 hours)
- Number of cases with orotracheal intubation(72 hours)
- Number of cases of death(72 hours)
- Level of Base excess(30 days)
- Level of cardiac output(30 days)
- Level of systolic volume(30 days)
- Level of arterial lactate(30 days)
- Rate of systolic and diastolic blood pressure(30 days)
- Level of troponin(30 days)
- heart rate(30 days)
- Level of potassium(30 days)
- Level of sodium(30 days)
- Level of creatinine(30 days)
- Level of urea(30 days)