Combined Physical Rehabilitation and Individualized Nutritional Support Versus Standard of Care During In-hospital Endocarditis Treatment
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Mental health (MH) measured by the standardized Short Form 36 (SF-36)
研究概览
简要总结
Infective endocarditis (IE) is associated with high morbidity and mortality. Patients with IE are affected by a lengthy hospitalization, leading to physical deconditioning and a rapid decline in physical fitness, muscle mass and strength. Moreover, prolonged antibiotic regimens frequently result in nausea, antibiotic-associated diarrhea and Clostridioides difficile (C.difficile) intestinal infections that further negatively affect patient health. These physical challenges are further exacerbated by the negative impact on mental health, increasing the overall burden of the illness. Implementing a targeted rehabilitative strategy in the hospital setting may therefore improve patient care including physical health and overall quality of life during hospitalization.
详细描述
BACKGROUND:
Infective endocarditis (IE) is a severe infection of the heart's inner lining, typically the valves, carrying high risks of acute heart failure and death. Patients often face extended hospitalizations (up to six weeks or longer) for intravenous antibiotic treatments, with 30-50% requiring urgent valve surgery. The incidence of IE is 8-10 per 100,000 person-years and rising due to aging populations and increased use of cardiac implantable devices, accounting for 650-700 cases annually in Denmark. Without treatment, mortality is nearly 100%, and with treatment, it ranges from 5-30% during the initial hospitalization, influenced by factors such as infection site, causative agent, age, and comorbidities.
IE significantly impacts patients' health due to prolonged hospitalization. Many experience rapid physical decline, including reduced cardiorespiratory fitness, strength, and overall fitness, caused by bed rest, malnutrition, and limited activity. Recovery is often difficult, with worsening physical, mental, and emotional states. The POET trial found poor self-rated health triples mortality risk. Up to 35% of patients do not return to work, and 65% face readmission within a year. Long hospital stays also increase the need for nursing home care.
Malnutrition is common in IE patients, raising risks of death, illness, and impairment. Acute illness amplifies nutritional deficits, worsening muscle wasting and overall health. The EFFORT trial showed early nutritional support reduces mortality and complications, yet no randomized studies have addressed nutrition in IE patients.
Intravenous antibiotics add distress, often causing nausea, diarrhea, and C. difficile infections. Probiotics like S. boulardii show promise in preventing these side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
There are none apart from listen above
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
- •Clinical diagnosis of left-sided (native, prosthetic, or culture-negative) bacterial infective endocarditis mandating iv antibiotic treatment, including Cardiac Implantable Electronic Devices infections, irrespective of cause and location as defined by the ESC modified Duke Criteria
- •Age ≥ 18 years
排除标准
- •Hemodynamic instability (defined as a systolic blood pressure <90 mmHg and lactate >2.2 mmol/l measured in an arterial blood gas.
- •Expected to be discharged within 3 days
- •Immunocompromised due to severe combined immunodeficiency, HIV, or hematological malignancy
- •Fungal endocarditis
- •Pregnancy
- •Unwilling or unable to sign or understand informed consent
结局指标
主要结局
Mental health (MH) measured by the standardized Short Form 36 (SF-36)
时间窗: 30 days
Mental Component Summary (MCS) of the Medical Outcome Study Short Form 36 version 2 (SF-36) which has been validated in Danish and in cardiac populations and is widely used in controlled clinical trials. Scores range from 0 to 100, with higher scores indicating better-perceived health
次要结局
- Change in number of sit and stand in 30 seconds from baseline to 14 days(14 days)
- Quality of life from EQ-5D(14, 30, and 90 days follow-up)
- Days alive without diarrhea(30 days in hospital and 90 days out of hospital)
- Days alive and out of hospital(30 day in hospital, and 90 day out-of-hospital)
- All-cause mortality(30 days)
研究者
Johannes Grand
MD, PhD
Copenhagen University Hospital, Hvidovre