Clinical trial NCT04833621: Is NMES Treatment in Sepsis/ Septic Shock Patients Protective in Development of ICU-AW?
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)?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intensive Care Unit Acquired Weakness
Sepsis, Severe
Keywords: ICU-AW
NMES
sarcopenia
sepsis.
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2021-04-06
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: SINGLE CENTER, PROSPECTIVE, DOUBLE BLINDED
Primary purpose: SUPPORTIVE_CARE

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 who's 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 who's 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 i.e. 3, 7, 14, 21, and 28. Sarcopenia was defined by anthropometric and ultrasonographic measurement, and all patient outcome data were recorded.

Eligibility criteria: Inclusion Criteria:

* Being in the Intensive Care Unit
* Over the age of 18
* Diagnosed with sepsis/ septic shock

Exclusion Criteria:

* Under the age of 18
* Pregnancy
* Having a cardiac pacemaker
* Amputated lower limbs
* Having severe venous insufficiency or major injuries to their lower extremities
* Having neuromuscular disease
* Malignancy

Primary outcomes:
measure: Effects of NMES treatment on ICU-AW development, anthropometric measurement,
timeFrame: 28 DAYS
measure: Effects of NMES treatment on ICU-AW development, ultrasonographic measurement
timeFrame: on the 1st, 3rd, 7th, 14th, 21st and 28th days
measure: Effects of NMES treatment on ICU-AW development, scoring systems.
timeFrame: on the 1st, 3rd, 7th, 14th, 21st and 28th days
measure: Effects of NMES treatment on ICU-AW development, scoring systems.
timeFrame: on the 1st, 3rd, 7th, 14th, 21st and 28th days
measure: Effects of NMES treatment on ICU-AW development, scoring systems.
timeFrame: first day
measure: Effects of NMES treatment on ICU-AW development, scoring systems.
timeFrame: first day
measure: Effects of NMES treatment on ICU-AW development, scoring systems.
timeFrame: 28 days
measure: Effects of NMES treatment on ICU-AW development, scoring systems.
timeFrame: 28 days
measure: Effects of NMES treatment on ICU-AW development, nutrition.
timeFrame: 28 days
measure: height
timeFrame: first day and last day ( end of the 28th day)
measure: weight
timeFrame: first day and last day (end of the 28th day)
Secondary outcomes:
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ondokuz Mayis University Faculty of Medicine
state: Atakum
Study officials:
References: