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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04205760
Other study ID # 19-136
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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)

Study Design


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
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