Clinical trial NCT04205760: Preoperative Nutritional Optimization and Physical Exercise for Patients Scheduled for Elective Implantation for a Left-Ventricular Assist Device
Official title: Preoperative Nutritional Optimization and Physical Exercise for Patients Scheduled for Elective Implantation for a Left-Ventricular Assist Device
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Left Ventricular Assist Device
End-stage Heart Failure
Cardiac Surgery
Keywords: LVAD
preoperative optimization
end-stage heart failure
cardiac surgery
nutrition therapy
exercise
cycling
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2019-12-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: National multicenter two-group randomized-controlled, blinded to assessor clinical pilot trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Comparison of adverse events
timeFrame: up to 2 weeks before surgery
measure: Separation of caloric supplementation
timeFrame: up to 2 weeks before surgery
measure: Separation of protein supplementation
timeFrame: up to 2 weeks before surgery
measure: Proportion of interventions received as prescribed
timeFrame: up to 2 weeks before surgery
measure: Rate of patients recruited per month
timeFrame: up to 18 months
measure: Ratio of control patients received physiotherapy
timeFrame: up to 2 weeks before surgery
measure: Ratio of control patients received nutritional support
timeFrame: up to 2 weeks before surgery
Secondary outcomes:
measure: mortality rates at day 30
timeFrame: day 30 after randomization
measure: rates of ICU length of stay
timeFrame: up to 3 months
measure: rates of hospital length of stay
timeFrame: up to 3 months
measure: Mean duration of mechanical ventilation
timeFrame: up to 3 months
measure: Incidence of complications
timeFrame: up to 3 months
measure: Incidence of infections
timeFrame: up to 3 months
measure: Change in Mid-arm circumference
timeFrame: up to 6 months
measure: Change in Muscle mass - Quadriceps thickness
timeFrame: up to 6 months
measure: Change in Muscle mass - Quadriceps cross sectional area
timeFrame: up to 6 months
measure: Change in Muscle strength - Handgrip strength
timeFrame: up to 6 months
measure: Change in Muscle strength - Quadriceps strength
timeFrame: up to 6 months
measure: Change of Clinical Frailty score (CFS)
timeFrame: up to 6 months
measure: Change in Physical function - 6-Minute Walk Test
timeFrame: up to 6 months
measure: Change in Physical function - Short Physical Performance Battery
timeFrame: up to 6 months
measure: Change in Physical function - Functional Status Score for the ICU
timeFrame: up to 6 months
measure: Change in quality of life - Lawton Instrumental Activities of Daily Living (IADL)
timeFrame: up to 6 months
measure: Change in quality of life - Katz Activities of Daily Living (ADL)
timeFrame: up to 6 months
measure: Quality of life - Short Form 36 (SF-36)
timeFrame: up to 6 months
measure: Change in neurological function - Mini Mental State Examination
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Bad Oeynhausen
country: Germany
facility: Heart Center Bad Oeynhausen
state: NRW
city: Aachen
country: Germany
facility: RWTH Aachen University
city: Dresden
country: Germany
facility: Heart Center Dresden
city: Giessen
country: Germany
facility: University Hospital Justus-Liebig University Giessen
city: Kiel
country: Germany
facility: University Medical Center Schleswig-Holstein, Campus Kiel
Study officials:
affiliation: RWTH Aachen University
name: Christian Stoppe, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: