Combined Rehabilitation and Nutritional Support vs. Standard Care in In-Hospital Endocarditis Treatment

NCT06563609 | Terminated

• 1 other identifier: ENDOCARE-001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bacteremia; Infective Endocarditis; Endocarditis, Bacterial; Infection; Heart; Cardiac Rehabilitation; Nutrition Intervention; Physical Therapy; Probiotic Intervention

Keywords

Infective endocarditis; Endocarditis team; Physical Therapy; Individualized Nutritional Support; Probiotic yeast Saccharomyces Boulardii; Cardiac rehabilitation

Outcome Measures

Primary Outcomes (1)

• Mental health (MH) measured by the standardized Short Form 36 (SF-36)

  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

  30 days

Secondary Outcomes (5)

• 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

Other Outcomes (12)

• Albumin Measurement

  14 days

• The occurrence of C. difficile infection

  14 days and 30 days

• NT-proBNP

  14 days after admission

Study Arms (4)

Integrated Physical Therapy and Nutritional Support with Probiotic Saccharomyces boulardii

ACTIVE COMPARATOR

Intensive physical therapy + individualised nutritional support + administration of probiotic yeast saccharomyces boulardii

Behavioral: Intensive physical Therapy; Dietary Supplement: Probiotic treatment; Behavioral: Individualised Nutritional Support

A combined Intensive physical Therapy and individualised Nutritional Support intervention

ACTIVE COMPARATOR

Intensive physical Therapy + Individualised Nutritional Support

Behavioral: Intensive physical Therapy; Behavioral: Individualised Nutritional Support

Administration of probiotic yeast Saccharomyces boulardii

ACTIVE COMPARATOR

Administration of probiotic yeast Saccharomyces boulardii

Dietary Supplement: Probiotic treatment

Control group

PLACEBO COMPARATOR

Standard hospital care

Other: Standard hospital care

Interventions

Intensive physical Therapy BEHAVIORAL

Tailored exercise programs supervised by trained physiotherapists, focusing on improving cardiorespiratory fitness, strength, and functional capacity.

A combined Intensive physical Therapy and individualised Nutritional Support intervention; Integrated Physical Therapy and Nutritional Support with Probiotic Saccharomyces boulardii

Probiotic treatment DIETARY_SUPPLEMENT

Administration of probiotic yeast Saccharomyces boulardii twice daily

Administration of probiotic yeast Saccharomyces boulardii; Integrated Physical Therapy and Nutritional Support with Probiotic Saccharomyces boulardii

Individualised Nutritional Support BEHAVIORAL

Personalized nutritional plans guided by a dietitian, addressing malnutrition and caloric/protein deficiencies with daily caloric intake adjustments and supplements if necessary based on the EFFORT trial.

A combined Intensive physical Therapy and individualised Nutritional Support intervention; Integrated Physical Therapy and Nutritional Support with Probiotic Saccharomyces boulardii

Standard hospital care OTHER

Patients will receive standard hospital care

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johannes Grand: lead

Study Sites (1)

Hvidovre Hospital

Hvidovre, 2650, Denmark

Location

MeSH Terms

Conditions

Endocarditis; Endocarditis, Bacterial; Infections; Bacteremia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Cardiovascular Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Johannes Grand, MD, PhD

  Copenhagen University Hospital Amager-Hvidovre, Department of Cardiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: There are none apart from listen above
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Model Details: Investigator-initiated, randomized, single-center, 2-by-2 factorial clinical trial with co-enrolment into two different non-pharmacological interventions. * A combined Intensive physical Therapy and individualised Nutritional Support intervention and administration of probiotic yeast Saccharomyces boulardii * A combined Intensive physical Therapy and individualised Nutritional Support intervention and NO administration of probiotic yeast Saccharomyces boulardii * Administration of probiotic yeast Saccharomyces boulardii and NO Intensive physical Therapy and individualised Nutritional Support. * NO administration of probiotic yeast Saccharomyces boulardii and NO Intensive physical Therapy and individualised Nutritional Support. Patients will receive standard hospital care

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 21, 2024
• Study Start: February 19, 2025
• Primary Completion: December 7, 2025
• Study Completion: December 7, 2025
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 1/1 2028 - 31/12 2037
• Access Criteria: Access will be granted to researchers who provide a methodologically sound proposal. All data avaiable will potentially be shared if approved be athorities. Data transfer can be made through an approoved data transfar system, which should be made available by the researcher seeking the data.

Locations

DK (1)