Ignite Creation Date:
2024-05-06 @ 7:09 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05919940
Status:
RECRUITING
Last Update Posted:
2024-02-06
First Post:
2023-06-06
Brief Title:
Improved Muscle Metabolism by Combination of Muscle Activation and Protein Substitution IMEMPRO
Sponsor:
Technical University of Munich
Organization:
Technical University of Munich
Study Overview
Official Title:
Improved Muscle Metabolism by Combination of Muscle Activation and Protein Substitution a Randomized Outcome-assessor Blinded Proof-of-concept Study IMEMPRO
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Intensive Care Unit Acquired Weakness ICUAW describes muscle weakness that occurs in around 40 of patients during an intensive care stay The morbidity and mortality of these patients is significantly increased over a 5-year period The aim of this study is to investigate the combined effect of early enteral high-protein nutrition and early muscle activation on muscle atrophy in critically ill patients
The study will include 40 patients 20 intervention 20 observation with requirement for enteral nutrition at time of inclusion In the intervention group the maximum possible level of mobilization is carried out and muscles are activated twice a day using neuromuscular electrical stimulation NMES The nutrition plan of the intervention group is based on the applicable guidelines for intensive care medicine with exception of increased protein intake The control group receives therapy without deviating from the standard according of the DGEM guideline
The study aims to show that the decrease in muscle mass is significantly less than in the control group primary hypothesis via ultrasound of the rectus femoris muscle and in case of given consent muscle biopsy As secondary hypothesis it is examined whether the combination of early high protein intake and muscle activation improves muscle strength and endurance
The study will include 40 patients 20 intervention 20 observation with requirement for enteral nutrition at time of inclusion In the intervention group the maximum possible level of mobilization is carried out and muscles are activated twice a day using neuromuscular electrical stimulation NMES The nutrition plan of the intervention group is based on the applicable guidelines for intensive care medicine with exception of increased protein intake The control group receives therapy without deviating from the standard according of the DGEM guideline
The study aims to show that the decrease in muscle mass is significantly less than in the control group primary hypothesis via ultrasound of the rectus femoris muscle and in case of given consent muscle biopsy As secondary hypothesis it is examined whether the combination of early high protein intake and muscle activation improves muscle strength and endurance
Detailed Description:
Intensive Care Unit Acquired Weakness ICUAW describes the clinically diagnosed manifestation of a neuromuscular organ dysfunction It develops in approximately 40 of all intensive care unit patients amounting to at least 12 million patients annually in Germany All these patients face a broad range of sequeleae and an increased mortality up to 5 years after ICU discharge A characteristic pathophysiological phenomenon is an early severe muscle atrophy reaching 10 during the first days after ICU admission
The current preventative and therapeutic approach for ICUAW is a combination of targeted risk factor management as well as early activation of muscles ie neuromuscular electrical stimulation NMES and early mobilization as they have been shown to counteract the muscle atrophy and mediate different outcome benefits such as shorter ICU stay
Nutrition is a key element of our daily life Protein intake has been shown to affect lean mass and muscle mass Research into specific nutritional strategies to treat or prevent ICUAW are scarce and the combination with early muscle activation has not been adequately explored
The study will include 40 patients 20 intervention 20 observation who were admitted to an intensive care unit within the last 48 hours A basic requirement for inclusion is an indication for enteral via the gastrointestinal tract nutrition at time of inclusion In the intervention group the ability to mobilize is assessed daily and the maximum possible level of mobilization is carried out and additional muscles are activated twice a day using neuromuscular electrical stimulation NMES The nutrition plan of the intervention group is based on the applicable guidelines for intensive care medicine In this study protein intake is increased in the interventional group The control group receives therapy without deviating from the standard according to the SOP and DGEM guideline Clinical nutrition in intensive care medicine 2018
The study aims to show that the decrease in muscle mass is significantly less than in the control group primary hypothesis via ultrasound of the rectus femoris muscle and muscle biopsy As a second hypothesis it is examined whether the combination of early high protein intake and muscle activation improves muscle strength and endurance compared to the control group
Further exploratory analyses will investigate changes in the skeletal muscle glycogen content skeletal muscle histology skeletal muscle gene expression skeletal muscle protein level as well as metabolomic changes in blood and urine
An additional blood sample will be taken after 90 days as part of a follow-up
The current preventative and therapeutic approach for ICUAW is a combination of targeted risk factor management as well as early activation of muscles ie neuromuscular electrical stimulation NMES and early mobilization as they have been shown to counteract the muscle atrophy and mediate different outcome benefits such as shorter ICU stay
Nutrition is a key element of our daily life Protein intake has been shown to affect lean mass and muscle mass Research into specific nutritional strategies to treat or prevent ICUAW are scarce and the combination with early muscle activation has not been adequately explored
The study will include 40 patients 20 intervention 20 observation who were admitted to an intensive care unit within the last 48 hours A basic requirement for inclusion is an indication for enteral via the gastrointestinal tract nutrition at time of inclusion In the intervention group the ability to mobilize is assessed daily and the maximum possible level of mobilization is carried out and additional muscles are activated twice a day using neuromuscular electrical stimulation NMES The nutrition plan of the intervention group is based on the applicable guidelines for intensive care medicine In this study protein intake is increased in the interventional group The control group receives therapy without deviating from the standard according to the SOP and DGEM guideline Clinical nutrition in intensive care medicine 2018
The study aims to show that the decrease in muscle mass is significantly less than in the control group primary hypothesis via ultrasound of the rectus femoris muscle and muscle biopsy As a second hypothesis it is examined whether the combination of early high protein intake and muscle activation improves muscle strength and endurance compared to the control group
Further exploratory analyses will investigate changes in the skeletal muscle glycogen content skeletal muscle histology skeletal muscle gene expression skeletal muscle protein level as well as metabolomic changes in blood and urine
An additional blood sample will be taken after 90 days as part of a follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None