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

Cardiac Surgery Clinical Trial

— PROPER-LVAD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04205760
• Other study ID #: 19-136
• Status: Recruiting
• Phase: Phase 3
• Start date: January 2, 2022
• Est. completion date: December 2, 2023

Study information

• Verified date: May 2022
• Source: RWTH Aachen University
• Contact: Aileen Hill, Dr. med.
• Phone: +49 241 80
• Email: ahill[@]ukaachen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2, 2023
• Est. primary completion date: July 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Combination Product:
• 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.

Locations

Country	Name	City	State
Germany	RWTH Aachen University	Aachen
Germany	Heart Center Bad Oeynhausen	Bad Oeynhausen	NRW
Germany	Heart Center Dresden	Dresden
Germany	University Hospital Justus-Liebig University Giessen	Giessen
Germany	University Medical Center Schleswig-Holstein, Campus Kiel	Kiel

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of adverse events	adverse events between groups related to cycling and nutritional complications	up to 2 weeks before surgery
Primary	Separation of caloric supplementation	Separation between groups on prescribed caloric targets	up to 2 weeks before surgery
Primary	Separation of protein supplementation	Separation between groups on prescribed protein targets	up to 2 weeks before surgery
Primary	Proportion of interventions received as prescribed	Proportion of interventions received as prescribed	up to 2 weeks before surgery
Primary	Rate of patients recruited per month	Target: 1.5 patients per month	up to 18 months
Primary	Ratio of control patients received physiotherapy	Ratio of control patients received physiotherapy	up to 2 weeks before surgery
Primary	Ratio of control patients received nutritional support	Ratio of control patients received nutritional support	up to 2 weeks before surgery
Secondary	mortality rates at day 30	mortality rates at day 30	day 30 after randomization
Secondary	rates of ICU length of stay	rates of ICU length of stay	up to 3 months
Secondary	rates of hospital length of stay	rates of hospital length of stay	up to 3 months
Secondary	Mean duration of mechanical ventilation	Mean duration of mechanical ventilation	up to 3 months
Secondary	Incidence of complications	Incidence of complications	up to 3 months
Secondary	Incidence of infections	Incidence of infections	up to 3 months
Secondary	Change in Mid-arm circumference	baseline values versus follow-up values	up to 6 months
Secondary	Change in Muscle mass - Quadriceps thickness	ultrasound, baseline values versus follow-up values	up to 6 months
Secondary	Change in Muscle mass - Quadriceps cross sectional area	ultrasound, baseline values versus follow-up values	up to 6 months
Secondary	Change in Muscle strength - Handgrip strength	Dynamometry, baseline values versus follow-up values	up to 6 months
Secondary	Change in Muscle strength - Quadriceps strength	Dynamometry, baseline values versus follow-up values	up to 6 months
Secondary	Change of Clinical Frailty score (CFS)	baseline values versus follow-up values; Score: 1-9 (very fit: 1, terminally ill: 9)	up to 6 months
Secondary	Change in Physical function - 6-Minute Walk Test	baseline values versus follow-up values, 6-minute walking distance	up to 6 months
Secondary	Change in Physical function - Short Physical Performance Battery	baseline values versus follow-up values,(Score: 0-12; 0=worst performance and 12=best performance)	up to 6 months
Secondary	Change in Physical function - Functional Status Score for the ICU	baseline values versus follow-up values,(Score 0-35; the higher the score, the better physical functioning)	up to 6 months
Secondary	Change in quality of life - Lawton Instrumental Activities of Daily Living (IADL)	baseline values versus follow-up values, (score 0-8; the higher the more independent)	up to 6 months
Secondary	Change in quality of life - Katz Activities of Daily Living (ADL)	baseline values versus follow-up values,(Score: 0-100; the higher the more independent)	up to 6 months
Secondary	Quality of life - Short Form 36 (SF-36)	baseline values versus follow-up values,(Score: 0-100; 100=no limitation in daily life and 0=completely limited)	up to 6 months
Secondary	Change in neurological function - Mini Mental State Examination	baseline values versus follow-up values, (score: 0-30; the higher the less cognitively impaired)	up to 6 months