Cardiac Surgery Clinical Trial
— PROPER-LVADOfficial title:
Preoperative Nutritional Optimization and Physical Exercise for Patients Scheduled for Elective Implantation for a Left-Ventricular Assist Device
This is a pilot, randomized, multicenter interventional trial of a combined preoperative oral nutritional support (ONS) and physical exercise therapy in patients planned for elective implantation of a left-ventricular assist device (LVAD). This pilot study pursues to demonstrate the feasibility and safety of a study protocol to optimize the patients' nutritional and physical state to reduce the number of postoperative complications and consequently to ameliorate the patients' outcome.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | December 2, 2023 |
Est. primary completion date | July 2, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Given informed consent 2. Adult patients (=18 years) 3. Patients undergoing elective LVAD implantation Additional cardiac surgery, such as bypass grafting, or valve repair is permitted Exclusion Criteria: 1. Hospital admission <5 days prior to planned LVAD implantation 2. Patients on ECMO or INTERMACS<1 3. Patients already receiving nutrition support on hospital admission 4. Enteral nutrition is contraindicated. 5. Pregnant or lactating patients 6. Patients with clinical fulminant hepatic failure 7. Patients with cirrhosis Child's Class C Liver Disease 8. Patients with clinical kidney failure or requiring hemodialysis 9. Known allergy or intolerance to study nutrients 10. Intracranial or spinal process affecting motor function 11. Lower extremity impairments that prevent cycling 12. Disabling neuropsychiatric disorders or language barriers 13. Weight > 150 kg 14. Enrolment in an industry sponsored randomized trial within the last 30 days (co-enrolment in academic randomized trials will be considered on a case by case basis) |
Country | Name | City | State |
---|---|---|---|
Germany | RWTH Aachen University | Aachen | |
Germany | Heart Center Bad Oeynhausen | Bad Oeynhausen | NRW |
Germany | Heart Center Dresden | Dresden | |
Germany | University Hospital Justus-Liebig University Giessen | Giessen | |
Germany | University Medical Center Schleswig-Holstein, Campus Kiel | Kiel |
Lead Sponsor | Collaborator |
---|---|
RWTH Aachen University |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of adverse events | adverse events between groups related to cycling and nutritional complications | up to 2 weeks before surgery | |
Primary | Separation of caloric supplementation | Separation between groups on prescribed caloric targets | up to 2 weeks before surgery | |
Primary | Separation of protein supplementation | Separation between groups on prescribed protein targets | up to 2 weeks before surgery | |
Primary | Proportion of interventions received as prescribed | Proportion of interventions received as prescribed | up to 2 weeks before surgery | |
Primary | Rate of patients recruited per month | Target: 1.5 patients per month | up to 18 months | |
Primary | Ratio of control patients received physiotherapy | Ratio of control patients received physiotherapy | up to 2 weeks before surgery | |
Primary | Ratio of control patients received nutritional support | Ratio of control patients received nutritional support | up to 2 weeks before surgery | |
Secondary | mortality rates at day 30 | mortality rates at day 30 | day 30 after randomization | |
Secondary | rates of ICU length of stay | rates of ICU length of stay | up to 3 months | |
Secondary | rates of hospital length of stay | rates of hospital length of stay | up to 3 months | |
Secondary | Mean duration of mechanical ventilation | Mean duration of mechanical ventilation | up to 3 months | |
Secondary | Incidence of complications | Incidence of complications | up to 3 months | |
Secondary | Incidence of infections | Incidence of infections | up to 3 months | |
Secondary | Change in Mid-arm circumference | baseline values versus follow-up values | up to 6 months | |
Secondary | Change in Muscle mass - Quadriceps thickness | ultrasound, baseline values versus follow-up values | up to 6 months | |
Secondary | Change in Muscle mass - Quadriceps cross sectional area | ultrasound, baseline values versus follow-up values | up to 6 months | |
Secondary | Change in Muscle strength - Handgrip strength | Dynamometry, baseline values versus follow-up values | up to 6 months | |
Secondary | Change in Muscle strength - Quadriceps strength | Dynamometry, baseline values versus follow-up values | up to 6 months | |
Secondary | Change of Clinical Frailty score (CFS) | baseline values versus follow-up values; Score: 1-9 (very fit: 1, terminally ill: 9) | up to 6 months | |
Secondary | Change in Physical function - 6-Minute Walk Test | baseline values versus follow-up values, 6-minute walking distance | up to 6 months | |
Secondary | Change in Physical function - Short Physical Performance Battery | baseline values versus follow-up values,(Score: 0-12; 0=worst performance and 12=best performance) | up to 6 months | |
Secondary | Change in Physical function - Functional Status Score for the ICU | baseline values versus follow-up values,(Score 0-35; the higher the score, the better physical functioning) | up to 6 months | |
Secondary | Change in quality of life - Lawton Instrumental Activities of Daily Living (IADL) | baseline values versus follow-up values, (score 0-8; the higher the more independent) | up to 6 months | |
Secondary | Change in quality of life - Katz Activities of Daily Living (ADL) | baseline values versus follow-up values,(Score: 0-100; the higher the more independent) | up to 6 months | |
Secondary | Quality of life - Short Form 36 (SF-36) | baseline values versus follow-up values,(Score: 0-100; 100=no limitation in daily life and 0=completely limited) | up to 6 months | |
Secondary | Change in neurological function - Mini Mental State Examination | baseline values versus follow-up values, (score: 0-30; the higher the less cognitively impaired) | up to 6 months |
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