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

NCT04205760 | Unknown Phase 3

• 1 other identifier: 19-136
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 5

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.

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

Outcome Measures

Primary Outcomes (7)

• Comparison of adverse events

  adverse events between groups related to cycling and nutritional complications

  up to 2 weeks before surgery

• Separation of caloric supplementation

  Separation between groups on prescribed caloric targets

  up to 2 weeks before surgery

• Separation of protein supplementation

  Separation between groups on prescribed protein targets

  up to 2 weeks before surgery

• Proportion of interventions received as prescribed

  Proportion of interventions received as prescribed

  up to 2 weeks before surgery

• Rate of patients recruited per month

  Target: 1.5 patients per month

  up to 18 months

• Ratio of control patients received physiotherapy

  Ratio of control patients received physiotherapy

  up to 2 weeks before surgery

• Ratio of control patients received nutritional support

  Ratio of control patients received nutritional support

  up to 2 weeks before surgery

Secondary Outcomes (19)

• mortality rates at day 30

  day 30 after randomization

• rates of ICU length of stay

  up to 3 months

• rates of hospital length of stay

  up to 3 months

• Mean duration of mechanical ventilation

  up to 3 months

• Incidence of complications

  up to 3 months

Study Arms (2)

Control group

NO INTERVENTION

Standard Care as per local guidelines

Intervention

EXPERIMENTAL

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

Combination Product: Nutrition + exercise

Interventions

Nutrition + exercise 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.

Also known as: bed cycling, ONS

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (5)

Heart Center Bad Oeynhausen

Bad Oeynhausen, North Rhine-Westphalia, Germany

RECRUITING

RWTH Aachen University

Aachen, Germany

RECRUITING

Heart Center Dresden

Dresden, Germany

NOT YET RECRUITING

University Hospital Justus-Liebig University Giessen

Giessen, Germany

NOT YET RECRUITING

University Medical Center Schleswig-Holstein, Campus Kiel

Kiel, Germany

NOT YET RECRUITING

MeSH Terms

Conditions

Motor Activity

Interventions

Nutritional Status; Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Christian Stoppe, Prof. Dr. med.

  RWTH Aachen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aileen Hill, Dr. med.

CONTACT

+49 241 80; ahill@ukaachen.de

Elena Laaf, MSc

CONTACT

+49 241 80; elaaf@ukaachen.de

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: functional outcome assessor will be blinded to study group allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Model Details: National multicenter two-group randomized-controlled, blinded to assessor clinical pilot trial

Study Record Dates

• First Submitted: December 18, 2019
• First Posted: December 19, 2019
• Study Start: January 2, 2022
• Primary Completion: July 2, 2023
• Study Completion: December 2, 2023
• Last Updated: May 26, 2022

Record last verified: 2022-05

Locations

DE (5)