Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04833621
Status:
COMPLETED
Last Update Posted:
2021-04-06
First Post:
2021-02-19
Brief Title:
Is NMES Treatment in Sepsis Septic Shock Patients Protective in Development of ICU-AW
Sponsor:
Ondokuz Mayıs University
Organization:
Ondokuz Mayıs University
Study Overview
Official Title:
Is Neuromuscular Electrical Stimulator Treatment in Sepsis Septic Shock Patients Protective in the Development of Intensive Care Unit Acquired Muscle Weakness ICU-AW
Status:
COMPLETED
Status Verified Date:
2021-03
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:
Background Sarcopenia muscle weakness characterized by a decrease in muscle mass strength and performance is a condition that increases with old age Sarcopenia can be seen in 5-13 of patients hospitalized in ICU where various treatment methods are used to prevent this weakness the rate increases in patients with sepsis septic shock Muscle treatment methods are used to prevent sarcopenia in similar patients hospitalized in ICU It is predicted that neuromuscular electrical stimulator-NMES treatment may increase muscle mass and strength in patients whos can not be exercised actively In this study the contribution of NMES treatment to prevent the development of muscle weakness in patients with a diagnosis of sepsis septic shock followed in intensive care units ICU was evaluated
Detailed Description:
Background Sarcopenia muscle weakness characterized by a decrease in muscle mass strength and performance is a condition that increases with old age Sarcopenia can be seen in 5-13 of patients hospitalized in ICU where various treatment methods are used to prevent this weakness the rate increases in patients with sepsis septic shock Muscle treatment methods are used to prevent sarcopenia in similar patients hospitalized in ICU It is predicted that neuromuscular electrical stimulator-NMES treatment may increase muscle mass and strength in patients whos can not be exercised actively In this study the contribution of NMES treatment to prevent the development of muscle weakness in patients with a diagnosis of sepsis septic shock followed in intensive care units ICU was evaluated
Patients and methods In our single-center prospective clinical study 80 patients with a diagnosis of sepsis septic shock who were hospitalized in ICU were included The effects of NMES and muscle strengthening and standard physiotherapy exercises on the development of ICU-AW were observed The day when our patients were diagnosed with sepsis was recorded as the first day of the study Anthropometric and ultrasonographic measurements of bilateral biceps brachii and bilateral rectus femoris muscles were recorded on the following days ie 3 7 14 21 and 28 Sarcopenia was defined by anthropometric and ultrasonographic measurement and all patient outcome data were recorded
Patients and methods In our single-center prospective clinical study 80 patients with a diagnosis of sepsis septic shock who were hospitalized in ICU were included The effects of NMES and muscle strengthening and standard physiotherapy exercises on the development of ICU-AW were observed The day when our patients were diagnosed with sepsis was recorded as the first day of the study Anthropometric and ultrasonographic measurements of bilateral biceps brachii and bilateral rectus femoris muscles were recorded on the following days ie 3 7 14 21 and 28 Sarcopenia was defined by anthropometric and ultrasonographic measurement and all patient outcome data were recorded
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