Rehabilitation and nutritional support for patients with infective endocarditis
Combined Physical Rehabilitation and Individualized Nutritional Support Versus Standard of Care During In-hospital Endocarditis Treatment
NA · Copenhagen University Hospital, Hvidovre · NCT06563609
This study tests whether adding rehabilitation and nutritional support to standard care can help hospitalized patients with infective endocarditis feel better and improve their health while they recover.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 92 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Copenhagen University Hospital, Hvidovre (other) |
| Locations | 1 site (Hvidovre) |
| Trial ID | NCT06563609 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of combined rehabilitation and nutritional support compared to standard care for patients hospitalized with infective endocarditis. It aims to address the physical and nutritional decline experienced during prolonged hospital stays due to this severe infection. The intervention includes intensive physical therapy, individualized nutritional support, and probiotic treatment to improve overall health outcomes. The study will assess the impact of these interventions on physical fitness, muscle mass, and quality of life during hospitalization.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with left-sided bacterial infective endocarditis requiring intravenous antibiotic treatment.
Not a fit: Patients who are hemodynamically unstable, expected to be discharged within three days, or have fungal endocarditis will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance recovery and quality of life for patients suffering from infective endocarditis.
How similar studies have performed: Previous studies have shown promising results with rehabilitation and nutritional support in similar patient populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
INCLUSION CRITERIA * 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 EXCLUSION CRITERIA * 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
Where this trial is running
Hvidovre
- Hvidovre Hospital — Hvidovre, Denmark (RECRUITING)
Study contacts
- Principal investigator: Johannes Grand, MD, PhD — Copenhagen University Hospital Amager-Hvidovre, Department of Cardiology
- Study coordinator: Johannes Grand, MD PhD MPH
- Email: johannes.grand@regionh.dk
- Phone: 35452121
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Infective Endocarditis, Endocarditis, Bacterial, Infection, Heart, Bacteremia, Cardiac Rehabilitation, Nutrition Intervention, Physical Therapy