Multi-intervention Trial: Improving Inhospital ENDOcarditis Treatment and CARE
NCT Number: NCT06563609
Acronym: ENDOCARE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Infective Endocarditis|Endocarditis, Bacterial|Infection; Heart|Bacteremia
Interventions: BEHAVIORAL: Intensive physical Therapy, individualised Nutritional Support|DIETARY_SUPPLEMENT: Probiotic treatment
Sponsor: Copenhagen University Hospital, Hvidovre
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 88
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-11-01
Completion Date: 2027-08-31

Summary:
Infective endocarditis (IE) is a raising public health challenge leading to high morbidity and mortality. Patients with IE are affected by a lengthy hospitalization, leading to physical deconditioning and a decline in physical fitness and strength. Moreover, prolonged antibiotic regimens frequently result in nausea, antibiotic-associated diarrhea and Clostridioides difficile (C.difficile) intestinal infections that further affect patients' health. A targeted rehabilitative strategy in the hospital setting might benefit to improve patient care including mental- and physical health and overall quality of life during their prolonged hospital stay.

The aim is to investigate the effects of two distinct interventions, each designed to decrease physical deconditioning and prevent treatment side effects for patients hospitalized with endocarditis.

Design: This is an investigator-initiated, randomized, single-center, 2-by-2 factorial clinical trial with co-enrolment into two different non-pharmacological interventions

Interventions: This study investigates the effects of two distinct interventions;

1. A combined Intensive Physical Therapy and individualized Nutritional Support intervention versus standard care (physical therapy and dietary according to hospital standards and standard hospital food).
2. Twice a day oral administration of the probiotic yeast S. boulardii at inclusion for as long as antibiotics (intravenous or orally) are given versus no probiotic treatment.

Primary Outcome Measures: Mental health (MH) measured by the standardized Short Form 36 (SF-36), MH after 30 days, 30days
Secondary Outcome Measures: Grip strength, Change in strength from baseline, 14 days, 30 days, 90 days|Quality of life from EQ-5D, Quality of life measured efte 30 days using EuroQol-5 Domain (EQ-5D) The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement., 30 days|Days alive without diarrhoea, Assessment with Bristol Stool Chart, 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|Self-rated mental health, Using 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., 14 days, 30 days, and 90 days
Other Outcome Measures: Albumin Measurement, 14 days|The occurrence of C. difficile infection, Defined as an episode of diarrhea combined with the detection of toxins A or B, or both, from a rectal swap, 14 days and 30 days|Echocardiography, Measurement of LVEF, TAPSE, TR-gradient, VCI-size and compressibility, e/é, significant valvular disease, left atrial volume (LA) volume or tricuspid regurgitation (TR) gradient, cardiac output by doppler-assessment, 14 days|Informant Questionnaire on Cognitive Decline in elderly (IQCODE), To be answered after lengthy hospitalization, 90 days|SENS motion, Number of daily steps, First 7 days