Preoperative Nutritional Optimization and Physical Exercise for Patients Scheduled for Elective Implantation for a Left-Ventricular Assist Device
- Conditions
- End-stage Heart FailureCardiac SurgeryLeft Ventricular Assist Device
- Interventions
- Combination Product: Nutrition + exercise
- Registration Number
- NCT04205760
- Lead Sponsor
- RWTH Aachen University
- Brief Summary
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.
- Detailed Description
The oral nutrition supplementation will be started immediately after randomization and will be continued until surgery. The patients will receive a dosage of ONS adjusted to their nutritional risk. Regular monitoring of blood sugars, electrolytes, phosphate, and triglycerides will occur twice per week, as per standard protocol.
In-bed cycling will be started as soon as possible after randomization. Cycling sessions will be performed daily for 50 minutes, at least 5 times a week until surgery. Standard safety criteria will be assessed prior to initiating cycling treatments. The in-bed cycling will be performed passively or actively with graded increasing resistance. All cycling interventions will be performed under 1:1 supervision of medically trained study personnel while monitoring patient's heart rate, systolic and diastolic blood pressure and transcutaneous oxygen saturation of blood.
When evaluating the effect of a combined nutritional and exercise intervention, other important co-interventions should be standardized to reduce potential confounding of trial outcomes. All study patients should be fed with an oral diet that is in accordance to local standards, whereas it is strongly recommended to adhere to current clinical practice guidelines. Besides, the investigators highly encourage daily respiratory therapy in both groups plus mobilization as much as feasible.
All other key interventions during preoperative treatment will be standardized in accordance to the local clinical practice. Study teams will follow up on the patients on a daily base, documenting adherence with study interventions and key co-interventions.
Patients in the control group will not receive preoperative ONS. No bed cycling will be allowed from admission until surgery. Neither of these practices are the current standard of care in the participating unit.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
- Given informed consent
- Adult patients (≥18 years)
- Patients undergoing elective LVAD implantation Additional cardiac surgery, such as bypass grafting, or valve repair is permitted
- Hospital admission <5 days prior to planned LVAD implantation
- Patients on ECMO or INTERMACS<1
- Patients already receiving nutrition support on hospital admission
- Enteral nutrition is contraindicated.
- Pregnant or lactating patients
- Patients with clinical fulminant hepatic failure
- Patients with cirrhosis Child's Class C Liver Disease
- Patients with clinical kidney failure or requiring hemodialysis
- Known allergy or intolerance to study nutrients
- Intracranial or spinal process affecting motor function
- Lower extremity impairments that prevent cycling
- Disabling neuropsychiatric disorders or language barriers
- Weight > 150 kg
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Nutrition + exercise Oral nutrition support (ONS) and bed-cycling before surgery
- Primary Outcome Measures
Name Time Method Rate of patients recruited per month up to 18 months Target: 1.5 patients per month
Separation of caloric supplementation up to 2 weeks before surgery Separation between groups on prescribed caloric targets
Separation of protein supplementation up to 2 weeks before surgery Separation between groups on prescribed protein targets
Proportion of interventions received as prescribed up to 2 weeks before surgery Proportion of interventions received as prescribed
Comparison of adverse events up to 2 weeks before surgery adverse events between groups related to cycling and nutritional complications
Ratio of control patients received physiotherapy up to 2 weeks before surgery Ratio of control patients received physiotherapy
Ratio of control patients received nutritional support up to 2 weeks before surgery Ratio of control patients received nutritional support
- Secondary Outcome Measures
Name Time Method Mean duration of mechanical ventilation up to 3 months Mean duration of mechanical ventilation
mortality rates at day 30 day 30 after randomization mortality rates at day 30
Quality of life - Short Form 36 (SF-36) up to 6 months baseline values versus follow-up values,(Score: 0-100; 100=no limitation in daily life and 0=completely limited)
rates of ICU length of stay up to 3 months rates of ICU length of stay
Incidence of complications up to 3 months Incidence of complications
Incidence of infections up to 3 months Incidence of infections
Change in Muscle strength - Handgrip strength up to 6 months Dynamometry, baseline values versus follow-up values
Change in Physical function - Functional Status Score for the ICU up to 6 months baseline values versus follow-up values,(Score 0-35; the higher the score, the better physical functioning)
rates of hospital length of stay up to 3 months rates of hospital length of stay
Change in Mid-arm circumference up to 6 months baseline values versus follow-up values
Change in Muscle mass - Quadriceps thickness up to 6 months ultrasound, baseline values versus follow-up values
Change in Physical function - Short Physical Performance Battery up to 6 months baseline values versus follow-up values,(Score: 0-12; 0=worst performance and 12=best performance)
Change in Muscle mass - Quadriceps cross sectional area up to 6 months ultrasound, baseline values versus follow-up values
Change in Muscle strength - Quadriceps strength up to 6 months Dynamometry, baseline values versus follow-up values
Change of Clinical Frailty score (CFS) up to 6 months baseline values versus follow-up values; Score: 1-9 (very fit: 1, terminally ill: 9)
Change in Physical function - 6-Minute Walk Test up to 6 months baseline values versus follow-up values, 6-minute walking distance
Change in quality of life - Lawton Instrumental Activities of Daily Living (IADL) up to 6 months baseline values versus follow-up values, (score 0-8; the higher the more independent)
Change in quality of life - Katz Activities of Daily Living (ADL) up to 6 months baseline values versus follow-up values,(Score: 0-100; the higher the more independent)
Change in neurological function - Mini Mental State Examination up to 6 months baseline values versus follow-up values, (score: 0-30; the higher the less cognitively impaired)
Trial Locations
- Locations (5)
Heart Center Bad Oeynhausen
🇩🇪Bad Oeynhausen, NRW, Germany
RWTH Aachen University
🇩🇪Aachen, Germany
University Hospital Justus-Liebig University Giessen
🇩🇪Giessen, Germany
Heart Center Dresden
🇩🇪Dresden, Germany
University Medical Center Schleswig-Holstein, Campus Kiel
🇩🇪Kiel, Germany