A Randomized Trial of Protocolized Diuretic Therapy Compared to Standard Care in Emergency Department Patients With Acute Heart Failure
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 474
- 试验地点
- 4
- 主要终点
- Clinical Status Score
研究概览
简要总结
This is a randomized trial of protocolized diuretic therapy guided by urinary sodium compared to structured usual care in ED patients with AHF. Participants will be recruited following an initial standard evaluation in the ED and randomized in a 1:1 fashion to structured usual care or protocolized diuretic therapy guided by urinary sodium.
详细描述
A standardized protocol driven treatment pathway for hospitalized patients started in the first few hours of ED evaluation and utilizing objective measures of diuretic response is needed. The investigators believe this would maximize diuretic efficiency, facilitate quicker resolution of congestion, avoid WHF and prolonged LOS, and reduce AHF readmissions. Propr data suggests low urine sodium predicts length of stay and outcomes after initial diuretic dosing in the outpatient and inpatient setting. Further, use of our pathway using spot urine sodium to titrate subsequent loop diuretic doses and maximize response in inpatients with AHF has shown compelling improvements in congestion and weight loss. However, a randomized trial is necessary to determine if initiating this protocol ,started in the ED, will improve AHF outcomes relative to structured usual care. Specifically, the investigators hypothesize use of spot urine sodium guided diuretic therapy will result in significant improvement in days of benefit over the 14 days after randomization. Days of benefit combines patient symptoms captured by global clinical status with clinical state quantifying the need for hospitalization and IV diuresis.
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
Triple blinded study of guideline-based care compared with a protocolized diuretic strategy using urinary sodium
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18
- •Emergency Department diagnosis of Acute Heart Failure (AHF)
- •Any one of the following:
- •i. Chest radiograph or lung ultrasound consistent with AHF ii. Jugular venous distension iii. Pulmonary rales on auscultation iv. Lower extremity edema v. S3 gallop
- •> 10 pounds of volume overload physician estimate or historical dry weight
- •IV diuretic ordered or planned to be during first 24 hours of ED or inpatient stay
排除标准
- •End Stage Renal Disease (ESRD) requiring dialysis
- •Need for immediate intubation
- •Acute Coronary Syndrome - presentation consistent with myocardial ischemia AND new ST-Segment elevation/depression
- •Temperature > 100.5ºF
- •End Stage Heart Failure: transplant list or ventricular assist device
- •Concurrent use of ototoxic medications including intravenous aminoglycosides and cisplatin
- •Systolic Blood Pressure < 90 mmHg at time of consent
- •LV outflow obstruction, severe uncorrected stenotic valvular disease or severe restrictive cardiomyopathy
- •Greater than 2 doses of IV diuretic administered at the time of screening from the time of the hospital presentation leading to this admission (outside hospital time is included)
- •Severe, uncorrected serum electrolyte abnormalities at the time of consent (serum potassium <3.0 mEq/L, magnesium <1.0 mEq/L or sodium <125 or >150 mEq/l)
- •Lack of informed consent
研究组 & 干预措施
Protocolized spot urine sodium guided diuretic therapy
Patients will have a spot urine sodium and urine creatinine obtained. The urine and creatinine results will be input into the diuretic calculator and the diuretic dose will be chosen based on daily goals for urine output and net negative fluid balance. Performed 3 times per day, diuretic dosing will be individualized based on the proportion of 24-hour diuresis achieved since the prior IV diuretic dose. Every 24 hours new goals for urine output and net negative fluid balance are established based on the study and treatment team's assessment of residual congestion until protocol completion.
干预措施: Protocolized diuretic therapy (Drug)
Guideline-based care
Patients will be placed on guideline-based diuretic dosing consistent with usual practice. The initial dose will be two times their home dose and will be subsequently adjusted by the treating team based on renal function and symptom severity. The treating team can increase or decrease the frequency and dose of diuretic based on urine output and clinical assessment. Patients in this arm also have urine collected 3 times per day by the bedside nurse to mirror the intervention arm.
结局指标
主要结局
Clinical Status Score
时间窗: From the time of randomization through day 14
Daily composite of the clinical state and global clinical status (GCS), expressed as an integer ranging in value from 0 (deceased) to 15 (outpatient; best possible GCS).
次要结局
- Home days(within 30 days from randomization)
- Inpatient clinical congestion(from the time of randomization through the end of protocolized IV diuretics, approximately 14 days)
- Cardiorenal Death and AHF Readmission(within 30 days of hospital discharge)
- Change in natriuretic peptides(from the time of randomization through the end of protocolized IV diuretics, approximately 14 days)
- Net fluid loss(from the time of randomization through the end of protocolized IV diuretics, approximately 14 days)
- Total urine output(from the time of randomization through the end of protocolized IV diuretics, approximately 14 days)
- Weight Loss(from the time of randomization through the end of protocolized IV diuretics, approximately 14 days)
- Home days(within 30 days from randomization)
- Global clinical status (GCS)(from the time of randomization through 14 days after randomization)
- Subclinical ototoxicity(at two time points: 1) the day of randomization and 2) the next calendar day after protocolized IV diuretics are stopped)
- Cumulative natriuresis(from the time of randomization through the end of protocolized diuretics, approximately 14 days)
- Average daily natriuresis(from the time of randomization through the end of protocolized diuretics, approximately 14 days)
研究者
Sean Collins
Professor
Vanderbilt University Medical Center