Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06563609
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
Multi-intervention Trial Improving Inhospital ENDOcarditis Treatment and CARE
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Improving Inhospital ENDOcarditis Treatment and CARE Through a Comprehensive Multi-intervention Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENDOCARE
Brief 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 Cdifficile 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
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
Detailed Description:
INDIVIDUALIZED NUTRITIONAL SUPPORT
Patients receive individualized nutritional support to meet their protein and caloric goals in accordance with a previously published consensus protocol that aligns with the 2018 international guidelines A dietician dietary trained nurse or investigator trained in dietary needs defines personalized nutritional goals for each patient using the weight-adjusted Harris-Benedict equation for predicting caloric requirements The daily protein intake is set between 12 and 15 gkg of body weight to account for increased protein breakdown during acute illness with lower targets for patients suffering from acute renal failure 08 gkg of body weight To achieve these goals a unique nutritional plan is crafted for each patient Additionally patients will be screened for refeeding syndrome Trained registered dieticians are consulted and will conduct the dietary protocol
If a patient cannot meet at least 75 of the daily caloric and protein targets for three consecutive days an escalation in nutritional support to enteral tube feeding or parenteral feeding is recommended Escalation in nutritional support to enteral tube feeding or parenteral feeding can be commenced sooner than three days if it is expected from clinical judgement that the patient will not meet the targets
In the control group patients will receive standard hospital food and protein drinks with no recommendation for nutritional support
INTENSIVE PHYSICAL THERAPY
Patients will receive Intensive Physical Therapy to reduce hospital-associated deconditioning and increase general well-being
The ENDOCARE team comprising of a cardiologist lead physician overseeing endocarditis treatment a nurse and a physiotherapist with the option for a family member to participate will convene for an interdisciplinary meeting aimed to individualize a pragmatic approach
The program will have two main modalities
1 Progressive resistance exercise of major muscle groups to mitigate loss of skeletal muscle mass
Various exercise equipment will be tested and determine patient preferences before familiarization After thorough instructions the patient is meant to be able to self-manage exercise - with spaced sessions with a physical therapist - to ensure the dosage is large enough to achieve the intended goal
2 Cardiovascular exercise andor habitual physical activity to mitigate loss of aerobic capacity or metabolic fitness
Cardiovascular exercise will use equipment if possible to ensure sufficient cardiorespiratory load if not contra-indicated We aim for 20 minutes of moderate intensity exercise BORG RPE 12-14 with three to four sessions per week either as continuous or interval exercise depending on patient preference Borg RPE will be used as a simple clinical tool to self-monitor intensity
Physical activity We will encourage daily physical activity corresponding to the Danish Health Authorities recommendation of 10000 stepsday using the accelerometer called SENS motion SENS Innovation ApS
In the control group patients will receive physical therapy in accordance with standard hospital care This includes initial assessment made by the physiotherapist and exercise sessions one to two times per week either supervised by the physiotherapist or self-manage exercise
ORAL ADMINISTRATION OF THE PROBIOTIC SACCHAROMYCES BOULARDII
In the intervention group S boulardii treatment is initiated at inclusion Patients will receive treatment with Sacchaflor capsules Pharmaforce Aps containing S boulardii and mannan oligosaccharide MOS a nutritional supplement derived from the cell wall of Saccharomyces cerevisiae 5 109 S boulardii strain of DBVPG 6763 200 mg MOS25 The capsules are administered twice daily totaling a daily dose of 1010 cells and continued until the end of the antibiotic treatment If the patient is discharged with a prescription for continued oral consumption of antibiotics within a week after being admitted the S boulardii treatment will continue as well after discharge for a maximum of 45 days
In the control group no probiotic treatment will be commenced for 45 days post inclusion
Patients receive individualized nutritional support to meet their protein and caloric goals in accordance with a previously published consensus protocol that aligns with the 2018 international guidelines A dietician dietary trained nurse or investigator trained in dietary needs defines personalized nutritional goals for each patient using the weight-adjusted Harris-Benedict equation for predicting caloric requirements The daily protein intake is set between 12 and 15 gkg of body weight to account for increased protein breakdown during acute illness with lower targets for patients suffering from acute renal failure 08 gkg of body weight To achieve these goals a unique nutritional plan is crafted for each patient Additionally patients will be screened for refeeding syndrome Trained registered dieticians are consulted and will conduct the dietary protocol
If a patient cannot meet at least 75 of the daily caloric and protein targets for three consecutive days an escalation in nutritional support to enteral tube feeding or parenteral feeding is recommended Escalation in nutritional support to enteral tube feeding or parenteral feeding can be commenced sooner than three days if it is expected from clinical judgement that the patient will not meet the targets
In the control group patients will receive standard hospital food and protein drinks with no recommendation for nutritional support
INTENSIVE PHYSICAL THERAPY
Patients will receive Intensive Physical Therapy to reduce hospital-associated deconditioning and increase general well-being
The ENDOCARE team comprising of a cardiologist lead physician overseeing endocarditis treatment a nurse and a physiotherapist with the option for a family member to participate will convene for an interdisciplinary meeting aimed to individualize a pragmatic approach
The program will have two main modalities
1 Progressive resistance exercise of major muscle groups to mitigate loss of skeletal muscle mass
Various exercise equipment will be tested and determine patient preferences before familiarization After thorough instructions the patient is meant to be able to self-manage exercise - with spaced sessions with a physical therapist - to ensure the dosage is large enough to achieve the intended goal
2 Cardiovascular exercise andor habitual physical activity to mitigate loss of aerobic capacity or metabolic fitness
Cardiovascular exercise will use equipment if possible to ensure sufficient cardiorespiratory load if not contra-indicated We aim for 20 minutes of moderate intensity exercise BORG RPE 12-14 with three to four sessions per week either as continuous or interval exercise depending on patient preference Borg RPE will be used as a simple clinical tool to self-monitor intensity
Physical activity We will encourage daily physical activity corresponding to the Danish Health Authorities recommendation of 10000 stepsday using the accelerometer called SENS motion SENS Innovation ApS
In the control group patients will receive physical therapy in accordance with standard hospital care This includes initial assessment made by the physiotherapist and exercise sessions one to two times per week either supervised by the physiotherapist or self-manage exercise
ORAL ADMINISTRATION OF THE PROBIOTIC SACCHAROMYCES BOULARDII
In the intervention group S boulardii treatment is initiated at inclusion Patients will receive treatment with Sacchaflor capsules Pharmaforce Aps containing S boulardii and mannan oligosaccharide MOS a nutritional supplement derived from the cell wall of Saccharomyces cerevisiae 5 109 S boulardii strain of DBVPG 6763 200 mg MOS25 The capsules are administered twice daily totaling a daily dose of 1010 cells and continued until the end of the antibiotic treatment If the patient is discharged with a prescription for continued oral consumption of antibiotics within a week after being admitted the S boulardii treatment will continue as well after discharge for a maximum of 45 days
In the control group no probiotic treatment will be commenced for 45 days post inclusion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None