Is NMES Treatment in Sepsis/ Septic Shock Patients Protective in Development of ICU-AW?

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-23

Study Completion Date

2020-10-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Intensive Care Unit Acquired Weakness Sepsis, Severe

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

SINGLE CENTER, PROSPECTIVE, DOUBLE BLINDED

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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NMES GROUP

NMES TREATMENT AND PHYSICAL TREATMENT

Group Type ACTIVE_COMPARATOR

NMES GROUP

Intervention Type DEVICE

The effects of NMES and muscle strengthening and standard physiotherapy exercises on the development of ICU-AW were observed

CONTROL GROUP

JUST PHYSICAL TREATMENT

Group Type ACTIVE_COMPARATOR

NMES GROUP

Intervention Type DEVICE

The effects of NMES and muscle strengthening and standard physiotherapy exercises on the development of ICU-AW were observed

Interventions

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NMES GROUP

The effects of NMES and muscle strengthening and standard physiotherapy exercises on the development of ICU-AW were observed

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No