OUTpatient Intravenous LASix Trial in Reducing Hospitalization for ADHF (OUTLAST)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 主要终点
- Re-hospitalization for Heart Failure
研究概览
简要总结
Single-center, prospective double-blinded randomized control trial to evaluate the the feasibility, efficacy and safety of outpatient IV diuretic therapy in treatment of heart failure.
详细描述
Patients were randomized by a clinical pharmacist with the ratio of 1:1:1 into 3 groups: standard of care control arm (Group 1), IV placebo infusion (Group 2), and IV furosemide infusion (Group 3).Patients in Group 2 and 3 received a comprehensive Heart Failure (HF)-care protocol that included bi-weekly clinic visits for dose-adjusted IV-diuretics, medication adjustment and education. Patients, nurses and treating physicians were blinded to the randomization. Patients in Group 1 received standard of care treatment per heart failure guidelines at the discretion of the primary cardiologist involved in the patient's care.8 Patients in Group 2 received IV saline infusion (20-40 ml) concentrated by the pharmacist to minimize fluid intake. Patients in Group 3 received IV furosemide calculated by the pharmacist to be equivalent or higher in dose compared to the patient's home oral dose. The dose assignments were categorized into low dose (20 mg bolus with 20 mg/hour infusion sessions and 2 ml saline), intermediate dose (40 mg bolus with 40 mg/hour infusion sessions and 4 ml saline) and high dose (80 mg bolus with 80 mg/hour infusion sessions). The infusions were continuous over 3 hours, biweekly over a one-month period. Infusions were held at the discretion of the physician utilizing a written protocol (creatinine 25% above baseline, Systolic Blood Pressure(SBP) <80 mmHg or symptoms of presyncope). Patients in both Groups 2 and 3 resumed all of their oral home medications for HF post infusion visits per standard of care.
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
Subjects, nurses and treating physicians will be blinded to whether the subjects are receiving continuous IV furosemide (group 2) or continuous IV placebo (group 3). The pharmacist will not be blinded to help administer the appropriate medication. Because the trial will be double-blinded, safety laboratory tests will be performed for each subject for the duration of the trial, regardless of the treatment arm, and will be monitored by the research coordinator. Similarly, monitoring of potential side effects will be continuous and irrespective of treatment assignment. Outcomes assessor will be blinded.
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
- •Patients being admitted with ADHF over 18 years old
- •Known history of systolic or diastolic dysfunction of greater than 6 weeks
- •NYHA Class II-IV
- •Heart failure as defined in [Table 1]. One symptom must be present at time of screening and one sign must be present in the last 12 months
- •Elevated pro-BNP >/= 360 pg/ml and not explained by any other etiology
- •Willing to consent and comply with scheduled visits and phone calls
- •Criteria for Diagnosing Heart Failure
- •SYMPTOMS (at least 1 must be present at time of screening):
- •Paroxysmal nocturnal dyspnea
- •Orthopnea
- •Dyspnea on mild or moderate exertion
- •SIGNS (at least 1 must be present in the last 12 months)
- •Any rales post cough
- •Jugular venous pressure >/= 10 cm H20
- •Lower extremity edema
- •Chest X-Ray (CXR) demonstrating pleural effusion, pulmonary congestion, or cardiomegaly
排除标准
- •Systolic blood pressure <85 mmHg
- •Signs of significant respiratory distress, according to the discretion of the investigator.
- •Biventricular Implantable Cardioverter-Defibrillator(ICD) placement within 15 days, cardiogenic shock or volume depletion
- •Chronic dialysis
- •Acute renal failure defined as creatinine > 2 x baseline
- •Severe systemic illness with life expectancy judged less than three years
- •Chronic pulmonary disease requiring home O2, oral steroid therapy or hospitalization for exacerbation within 12 months, or significant chronic pulmonary disease in the opinion of the investigator
- •Primary hemodynamically significant uncorrected valvular heart disease, obstructive, or regurgitant, or any valvular disease expected to lead to surgery during the trial.
- •Atrial fibrillation with resting heart rate >90 bpm
- •Myocardial infarction in past 90 days
- •Percutaneous coronary intervention in past 30 days
- •Heart transplant recipient or currently implanted left ventricular assist device
- •Stroke in past 90 days
- •No acute infection especially requiring IV antibiotics
- •Allergy to Lasix
- •Known chronic hepatic disease, defined as aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels > 3.0 times the upper limit of normal
- •Non-verbal patients, patients who cannot speak or understand English, patients with dementia and psychiatric illness, patients who are blind or deaf and patients who are transferred to different hospital will be excluded.
研究组 & 干预措施
IV Placebo Infusion
Patients in Group 2 received IV saline infusion (20-40 ml) concentrated by the pharmacist to minimize fluid intake.The infusions were continuous over 3 hours, biweekly over a one-month period.
干预措施: IV Solution (Drug)
IV Furosemide Infusion
The dose assignments were categorized into low dose (20 mg bolus with 20 mg/hour infusion sessions and 2 ml saline), intermediate dose (40 mg bolus with 40 mg/hour infusion sessions and 4 ml saline) and high dose (80 mg bolus with 80 mg/hour infusion sessions). The infusions were continuous over 3 hours, biweekly over a one-month period.Infusions were held at the discretion of the physician utilizing a written protocol (creatinine 25% above baseline, SBP <80 mmHg or symptoms of presyncope).
干预措施: Furosemide (Drug)
结局指标
主要结局
Re-hospitalization for Heart Failure
时间窗: 30 days
30-day rehospitalization for Heart Failure
次要结局
- Kansas City Cardiomyopathy Questionnaire(KCCQ) outcome measures(Change from Baseline to 30 days)
- Death, Myocardial Infarction, Stroke(30 days, 180 days)
- PHQ-2 outcome measures(Change from Baseline to 30 days)
研究者
Dr John Heitner
Co-Director of Cardiovascular Research
New York Presbyterian Brooklyn Methodist Hospital