Above-Knee-High Application of Lower Limb Compression and Its Impact on Clinical Outcome in Patients Hospitalized With Heart Failure Exacerbation.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Length of stay in the hospital
研究概览
简要总结
Heart failure (HF) remains one of the most common causes of hospitalization with high morbidity and mortality, and its worldwide prevalence is increasing. Despite notable progress in outcomes for HF the rate of early rehospitalization for HF (re-HHF) remains high, especially in the first 30 days. The rate of 30-day HF rehospitalization in the claims databases of the USA and in worldwide randomized clinical trials is 20-25% and 5-10% respectively.
In patients with bilateral leg edema, the presence of CHF (congestive heart failure) as the factor causing or worsening local leg swelling should be evaluated. Application of local leg compression can be considered in stable CHF patients without decompensated heart function (NYHA Class I and II) for both CHF-related edema treatment and for treatment of concomitant diseases leading to leg swelling occurrence. Current literature does not have recommendations on the routine use of lower limb compression in leg swelling related to end stage heart disease and advanced, decompensated heart failure. Potential benefits of applying medical compression in more severe classes of CHF (NYHA Class III and IV) would need to be evaluated by further randomized clinical studies to determine which cohort of patients would benefit most from lower limb compression, as well as to choose the safest and most efficient compression protocol for these patients.
The AIM of this study is to improve the clinical outcome of patients admitted with exacerbation of heart failure with associated volume overload.
The primary objectives are: 1) diminish the duration of hospitalization of CHF patients; 2) decrease the incidence of rehospitalization from CHF exacerbation and 3) prevent local complications associated with prolonged lower extremity edema.
The investigators hypothesize that the application of local compression to bilateral lower extremities, when added to guideline-based therapy for CHF exacerbation, will improve overall clinical outcome in patients at the University of Texas Medical Branch (UTMB). If our intervention is proven to be beneficial, it could lead to a significant reduction in nationwide hospitalization costs associated with heart failure.
详细描述
The growing number of patients with potentially heart-affecting diseases, including arterial hypertension, diabetes, and heart ischemic disease, as well as the ageing of the population, has resulted in a growing number of patients with advanced stages of CHF. The average number of days for an HF-related hospitalization in the United States is about 6 to 8 days. Hospitalization costs associated with heart failure averaged $23,077 and were higher when heart failure was a secondary rather than the primary diagnosis.
The presence of CHF results in a significant risk of leg oedema. Medical compression (MC) treatment is one of the basic methods of leg oedema elimination in patients with chronic venous disease and lymphedema, but it is not routinely considered in subjects with CHF-related swelling. In addition to chronic venous disease, bilateral leg swelling can also occur in other pathological conditions, including occupational leg oedema, lymphedema, obesity, or hypoalbuminemia. Lower extremity edema can significantly affect the patient's general condition and quality of life. The symptoms of leg heaviness, cramps & mobility limitations could be accompanied by signs of local skin injuries, transcutaneous migration of fluid, skin discoloration or stasis dermatitis and skin induration. In more advanced and permanent swelling, the sequence of fluid transudation and epithelial maceration can lead to the development of large skin and subcutaneous tissue defects, with formation of chronic lower extremity ulcers. In cases where lower extremity lesions or wounds are already present, the presence of heart failure with volume overload can significantly impair the healing process of the local pathology.
Despite the common use of compression therapy in the treatment of leg swelling of venous and lymphatic origin, guidelines regarding its potential use in HF-related edema have not been specified. This is due to lack of sufficient number of properly performed studies in this field as well as a heterogenous population of heart failure patients with several classes of disease severity. As documented in the available literature, compression treatment can potentially be used in selected HF patients.
Patients who are admitted with heart failure exacerbation with clinical evidence of volume overload in the form of lower extremity edema will be randomly assigned in a 1:1 ratio to either the Control group or Compression group.
Patients, care providers (Heart failure specialist) and outcome-assessing physicians would be blinded to arm assignment.
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
- Triple (Participant, Care Provider, 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
- •Patients who are admitted with heart failure exacerbation with clinical evidence of volume overload in the form of lower extremity pitting edema.
- •Patients who are not yet recruited for other pharmacological or medical device clinical trials.
排除标准
- •Age <18 years.
- •Patient on hemodialysis or peritoneal dialysis.
- •Simultaneous participation in another interventional study.
- •Impossibility to perform lower extremity compression, caused by pathology in either or both lower limbs (e.g. amputation, chronic wounds).
- •No written informed consent.
- •Patient who are on invasive or non-invasive positive pressure ventilation (including BiPAP) or who are requiring >15L of oxygen.
- •Cardiogenic shock requiring catecholamine infusion.
- •Systolic blood pressure <80 mmHg.
- •Patients requiring mechanical circulatory support including intra-aortic balloon counter-pulsation or impella.
- •Patients on VAD (Ventricular Assist Device).
- •Severe peripheral artery disease
- •Diagnosis of lower extremity deep venous thrombosis or pulmonary embolism in the last 3 months
- •Expected impossibility to obtain follow-up data at 12-week follow-up.
- •Pregnant women.
结局指标
主要结局
Length of stay in the hospital
时间窗: up to 60 days
Calculated by subtracting the day of admission from day of discharge.
次要结局
- Death from all causes(Death from all causes within the first 30 days as well as within the first 90 days after discharge from index hospitalization)
- Incidence of 30-day rehospitalization(The incidence of rehospitalization or readmission within the first 30 days after discharge)
- Cardiovascular deaths(Cardiovascular deaths within the first 30 days as well as within the first 90 days after discharge from index hospitalization)
- Duration of IV diuretics therapy(up to 30 days)
- Incidence of 90-day rehospitalization(The incidence of rehospitalization or readmission within the first 90 days after discharge)
- Incidence of AKI(Up to 60 days)
- Major adverse cardiac event within 30 days of discharge from index hospitalization(Major adverse cardiac event within the first 30 days as well as within the first 90 days after discharge from index hospitalization)
- Incidence of orthostatic hypotension(after 48 hours but before 72 hours after application of compression stocking)
- Change in serum BNP level at discharge in comparison to admission(up to 60 days)
- Incidence of cutaneous lesions following application of compression stockings.(up to 60 days)