Compression Wraps as Adjuvant Therapy in the Management of Acute Systolic Heart Failure (CATAS-HF)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Days on IV Diuretic Therapy
研究概览
简要总结
There will be two populations in this study: control group, and intervention group. These groups will undergo propensity matching to account for confounders and minimize selection bias. 120 patients will be enrolled, 60 to each population. The objective of this study is: assess the utility of lower extremity compression wraps as adjuvant therapy in inpatient management of acute systolic heart failure
The control group will consist of patients admitted to I5 Cardiology for management of acute systolic heart failure with intravenous diuresis and standard medical therapy, meeting inclusion criteria. Information will be gathered through observational prospective data analysis from Epic EMR, and will include daily diuretic type and dose required, daily urine output, daily creatinine, total days of admission, daily and pre-discharge weight, admission BNP, and pre-discharge BNP.
The intervention group will consist of patients admitted to I5 Cardiology meeting inclusion criteria and being managed with standard medical therapy. This group will receive additional therapy using bilateral lower extremity compression wraps applied by nursing staff per pre-set protocol, and will receive education on the use of compression wraps. Patients will be instructed to wear the compression wraps for the entirety of the time they are undergoing intravenous diuresis, with pauses in care as needed for hygiene and symptom relief purposes. During the time of compression wrap application, the following data will be collected: urine output, daily weights, daily creatinine, daily and total dose and type of intravenous diuretic used. Prior to discharge, a BNP will be obtained.
Endpoints (including percentage of weight reduction, total urine output achieved with diuresis, total dose requirement and type of intravenous diuresis, total days of intravenous diuresis, days to discharge, discharge BNP, and percent reduction from admission BNP) will then be compared to assess the utility of adding lower extremity compression wraps to inpatient management of acute systolic heart failure.
详细描述
There will be two populations in this study: control group, and intervention group. 120 patients will be enrolled, 60 to group, randomized in 1:1 fashion. The control group will consist of patients admitted to I5 Cardiology for management of acute systolic heart failure with intravenous diuresis and standard medical therapy, meeting inclusion criteria. Information will be gathered through observational prospective data analysis from Epic EMR, and will include daily diuretic type and dose required, daily urine output, daily creatinine, total days of admission, daily and pre-discharge weight, admission BNP, and pre-discharge BNP. The intervention group will consist of patients admitted to I5 Cardiology meeting inclusion criteria and being managed with standard medical therapy. This group will receive additional therapy using bilateral lower extremity compression wraps applied by nursing staff per pre-set protocol, and will receive education on the use of compression wraps. Patients will be instructed to wear the compression wraps for the entirety of the time they are undergoing intravenous diuresis, with pauses in care as needed for hygiene and symptom relief purposes. During the time of compression wrap application, the following data will be collected: urine output, daily weights, daily creatinine, daily and total dose and type of intravenous diuretic used. Prior to discharge, a BNP will be obtained. Endpoints (including percentage of weight reduction, total urine output achieved with diuresis, total dose requirement and type of intravenous diuresis, total days of intravenous diuresis, days to discharge, discharge BNP, and percent reduction from admission BNP) will then be compared to assess the utility of adding lower extremity compression wraps to inpatient management of acute systolic heart failure.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age greater than 18 and less than 85 years of age
- •admitted to I5 with Acute Systolic Heart Failure with an ejection fraction of less than 50% as determined by echocardiogram within 6 months
- •requiring inpatient management with intravenous diuresis.
- •diagnosis of acute systolic heart failure, of any underlying etiology
- •at least 2+ pitting edema (or documented lower extremity pitting edema of at least moderate or significant severity) on primary assessment.
排除标准
- •cannot tolerate IV diuresis
- •who cannot wear or tolerate lower extremity compression stockings or wraps
- •peripheral neuropathy
- •ejection fraction greater than 50% as evaluated by echocardiogram within 6 months
结局指标
主要结局
Days on IV Diuretic Therapy
时间窗: From admission to hospital discharge, up to 30 days
Assess the number of days from start of IV diuresis to transition to PO diuresis
Number of Participants With Readmission Within 30-days
时间窗: 30 days from hospital discharge
Assess rate of 30-day readmission of patients enrolled in study
Total Length of Hospital Stay
时间窗: From admission to hospital discharge, up to 30 days
Assess the length of hospitalization, controlling for variables
次要结局
- Average Percentage of BNP Change(From admission to hospital discharge, up to 30 days)
- Net Intake/Output of Fluids During Hospitalization(From admission to hospital discharge, up to 30 days)
- Average Percentage of Weight Change During Hospitalization(From admission to hospital discharge, up to 30 days)
- IV Diuretic Infusion Used(From admission to hospital discharge, up to 30 days)
- AKI During Hospitalization(From admission to hospital discharge, up to 30 days)
- Average Pre-discharge BNP(From admission to hospital discharge, up to 30 days)
研究者
Joseph Miller, MD
Emergency Medicine, Internal Medicine Physician
Henry Ford Health System