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

NCT ID: NCT04205760

Last Updated: 2022-05-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-02
• Study Completion Date: 2023-12-02

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.

Conditions

Left Ventricular Assist Device; End-stage Heart Failure; Cardiac Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control group

Standard Care as per local guidelines

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

Oral nutrition support (ONS) and bed-cycling before surgery

Group Type: EXPERIMENTAL

Nutrition + exercise

Intervention Type: COMBINATION_PRODUCT

Patients will receive preoperative optimization consisting of oral nutrition support (Fresubin 3.2 kcal) and bed-cycling (50 minutes per day) for 5-14 days before surgery.

Interventions

Nutrition + exercise

Patients will receive preoperative optimization consisting of oral nutrition support (Fresubin 3.2 kcal) and bed-cycling (50 minutes per day) for 5-14 days before surgery.

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

bed cycling; ONS

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RWTH Aachen University

OTHER

Sponsor Role: lead

Responsible Party

Christian Stoppe

Prof. Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christian Stoppe, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

RWTH Aachen University

Locations

Heart Center Bad Oeynhausen

Bad Oeynhausen, North Rhine-Westphalia, Germany

Site Status: RECRUITING

RWTH Aachen University

Aachen, , Germany

Site Status: RECRUITING

Heart Center Dresden

Dresden, , Germany

Site Status: NOT_YET_RECRUITING

University Hospital Justus-Liebig University Giessen

Giessen, , Germany

Site Status: NOT_YET_RECRUITING

University Medical Center Schleswig-Holstein, Campus Kiel

Kiel, , Germany

Site Status: NOT_YET_RECRUITING

Countries

Germany

Central Contacts

Aileen Hill, Dr. med.

Role: CONTACT

ahill@ukaachen.de

+49 241 80 ext. 38166

Elena Laaf, MSc

Role: CONTACT

elaaf@ukaachen.de

+49 241 80 ext. 89021

Facility Contacts

Vera von Dossow

Role: primary

Aileen Hill, Dr. med.

Role: primary

Elena Laaf, MSc

Role: backup

Klaus Matschke, Univ.-Prof. Dr. med. habil.

Role: primary

Bernd Niemann, PD Dr. med.

Role: primary

Bernd Panholzer, Dr. med.

Role: primary

Other Identifiers

19-136

Identifier Type: -

Identifier Source: org_study_id