Preoperative Nutritional Optimization and Physical Exercise for Patients Scheduled for Elective Implantation for a Left-Ventricular Assist Device (PROPER-LVAD)

RWTH Aachen University

Status and phase

Unknown

Phase 3

Conditions

Cardiac Surgery

End-stage Heart Failure

Left Ventricular Assist Device

Treatments

Combination Product: Nutrition + exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT04205760

19-136

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Given informed consent
Adult patients (≥18 years)
Patients undergoing elective LVAD implantation Additional cardiac surgery, such as bypass grafting, or valve repair is permitted

Exclusion criteria

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)