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

O

Ondokuz Mayıs University

Status

Completed

Conditions

Intensive Care Unit Acquired Weakness
Sepsis, Severe

Treatments

Device: NMES GROUP

Study type

Interventional

Funder types

Other

Identifiers

NCT04833621
01.02.2018 V:01

Details and patient eligibility

About

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.

Full 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.

Enrollment

148 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

148 participants in 2 patient groups

NMES GROUP
Active Comparator group
Description:
NMES TREATMENT AND PHYSICAL TREATMENT
Treatment:
Device: NMES GROUP
CONTROL GROUP
Active Comparator group
Description:
JUST PHYSICAL TREATMENT
Treatment:
Device: NMES GROUP

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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