Is NMES Treatment in Sepsis/ Septic Shock Patients Protective in Development of ICU-AW?
Primary Purpose
Intensive Care Unit Acquired Weakness, Sepsis, Severe
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
NMES GROUP
Sponsored by
About this trial
This is an interventional supportive care trial for Intensive Care Unit Acquired Weakness focused on measuring ICU-AW, NMES, sarcopenia, sepsis.
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
Sites / Locations
- Ondokuz Mayis University Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
NMES GROUP
CONTROL GROUP
Arm Description
NMES TREATMENT AND PHYSICAL TREATMENT
JUST PHYSICAL TREATMENT
Outcomes
Primary Outcome Measures
Effects of NMES treatment on ICU-AW development, anthropometric measurement,
The measurements of the patients were recorded as anthropometric (arm circumference and thigh circumference) on the 1st, 3rd, 7th, 14th, 21st and 28th days. Arm circumference(centimeter) measurement was measured from the thickest part of the biceps muscle(centimeter) when the elbow was flexed and thigh circumference (centimeter) was measured anthropometrically with a tape measure (centimeter), 15 centimeter above the patella with the leg in extension.
Effects of NMES treatment on ICU-AW development, ultrasonographic measurement
Using an ultrasound imaging device, the thickness of biceps brachii (cm^2) and rectus femoris muscles (cm^2) were measured ultrasonographically (at the same points of anthropometric measurements) with the linear probe.
Effects of NMES treatment on ICU-AW development, scoring systems.
The muscle strength of the patients were evaluated according to the Medical Research Council (MRC) scoring.
Effects of NMES treatment on ICU-AW development, scoring systems.
On the first day of the study, SOFA (Sequential Organ Failure Assessment) score,scoring systems were calculated for each patients.
Effects of NMES treatment on ICU-AW development, scoring systems.
On the first day of the study, qSOFA (quick Sequential Organ Failure Assessment) score scoring systems were calculated for each patients.
Effects of NMES treatment on ICU-AW development, scoring systems.
On the first day of the study, APACHE-II (Acute Physiology And Chronic Health Evaluation II) scoring systems were calculated for each patients.
Effects of NMES treatment on ICU-AW development, scoring systems.
When the follow-up was completed, duration of the ICU stay, intubated and/ or extubated days.
Effects of NMES treatment on ICU-AW development, scoring systems.
When the follow-up was completed, duration of the ICU stay, , last BMI (body mass index)(kg/m^2) were recorded.
Effects of NMES treatment on ICU-AW development, nutrition.
The diet of the patients were standardized by the dietitian.
height
The height of the patients was calculated by measuring the knee height from many alternative height measurement methods. The measurement includes the length from the base of the foot to the anterior surface of the thigh while the lower extremity is flexed and is easily taken Chumlea et al. The equation created by the Chumlea method, known as the Chumlea method, is the most accurate equation used to estimate standing height from knee height. This method has been cross-validated for use in ICU patients. The original estimated equations are given.
White Male Estimated height (cm) = (knee height (cm) × 1.88) + 71.85 White Female Estimated height (cm) = (knee height (cm) × 1.87) - (0.06 × age (y)) + 70.25
weight
We calculated the body weight of our patients by indirectly using the method of calculating body weight in bedridden patients.
Age (Year) 6-18 Male : (Knee length (cm) x 0.68) + (Arm circumference (cm)x 2.64) -50.08 Female : (Knee (cm) x 0.77) + (Arm (cm) x 2.47) - 50.16
19-59 Male : (Knee (cm) x 1.19) + (Arm (cm) x 3.21) -86.82 Female : (Knee (cm) x 1.01) + (Arm (cm) x 2.81) - 66.04
60-80 Male : (Knee (cm) x 1.10) + (Arm (cm) x 3.07) -75.81 Female : (Knee (cm) x 1.09) + (Arm circumference(cm) x 2.68) - 65.51
Secondary Outcome Measures
Full Information
NCT ID
NCT04833621
First Posted
February 19, 2021
Last Updated
April 4, 2021
Sponsor
Ondokuz Mayıs University
1. Study Identification
Unique Protocol Identification Number
NCT04833621
Brief Title
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
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
October 23, 2018 (Actual)
Primary Completion Date
October 1, 2020 (Actual)
Study Completion Date
October 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ondokuz Mayıs University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intensive Care Unit Acquired Weakness, Sepsis, Severe
Keywords
ICU-AW, NMES, sarcopenia, sepsis.
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
SINGLE CENTER, PROSPECTIVE, DOUBLE BLINDED
Masking
Investigator
Allocation
Randomized
Enrollment
148 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NMES GROUP
Arm Type
Active Comparator
Arm Description
NMES TREATMENT AND PHYSICAL TREATMENT
Arm Title
CONTROL GROUP
Arm Type
Active Comparator
Arm Description
JUST PHYSICAL TREATMENT
Intervention Type
Device
Intervention Name(s)
NMES GROUP
Intervention Description
The effects of NMES and muscle strengthening and standard physiotherapy exercises on the development of ICU-AW were observed
Primary Outcome Measure Information:
Title
Effects of NMES treatment on ICU-AW development, anthropometric measurement,
Description
The measurements of the patients were recorded as anthropometric (arm circumference and thigh circumference) on the 1st, 3rd, 7th, 14th, 21st and 28th days. Arm circumference(centimeter) measurement was measured from the thickest part of the biceps muscle(centimeter) when the elbow was flexed and thigh circumference (centimeter) was measured anthropometrically with a tape measure (centimeter), 15 centimeter above the patella with the leg in extension.
Time Frame
28 DAYS
Title
Effects of NMES treatment on ICU-AW development, ultrasonographic measurement
Description
Using an ultrasound imaging device, the thickness of biceps brachii (cm^2) and rectus femoris muscles (cm^2) were measured ultrasonographically (at the same points of anthropometric measurements) with the linear probe.
Time Frame
on the 1st, 3rd, 7th, 14th, 21st and 28th days
Title
Effects of NMES treatment on ICU-AW development, scoring systems.
Description
The muscle strength of the patients were evaluated according to the Medical Research Council (MRC) scoring.
Time Frame
on the 1st, 3rd, 7th, 14th, 21st and 28th days
Title
Effects of NMES treatment on ICU-AW development, scoring systems.
Description
On the first day of the study, SOFA (Sequential Organ Failure Assessment) score,scoring systems were calculated for each patients.
Time Frame
on the 1st, 3rd, 7th, 14th, 21st and 28th days
Title
Effects of NMES treatment on ICU-AW development, scoring systems.
Description
On the first day of the study, qSOFA (quick Sequential Organ Failure Assessment) score scoring systems were calculated for each patients.
Time Frame
first day
Title
Effects of NMES treatment on ICU-AW development, scoring systems.
Description
On the first day of the study, APACHE-II (Acute Physiology And Chronic Health Evaluation II) scoring systems were calculated for each patients.
Time Frame
first day
Title
Effects of NMES treatment on ICU-AW development, scoring systems.
Description
When the follow-up was completed, duration of the ICU stay, intubated and/ or extubated days.
Time Frame
28 days
Title
Effects of NMES treatment on ICU-AW development, scoring systems.
Description
When the follow-up was completed, duration of the ICU stay, , last BMI (body mass index)(kg/m^2) were recorded.
Time Frame
28 days
Title
Effects of NMES treatment on ICU-AW development, nutrition.
Description
The diet of the patients were standardized by the dietitian.
Time Frame
28 days
Title
height
Description
The height of the patients was calculated by measuring the knee height from many alternative height measurement methods. The measurement includes the length from the base of the foot to the anterior surface of the thigh while the lower extremity is flexed and is easily taken Chumlea et al. The equation created by the Chumlea method, known as the Chumlea method, is the most accurate equation used to estimate standing height from knee height. This method has been cross-validated for use in ICU patients. The original estimated equations are given.
White Male Estimated height (cm) = (knee height (cm) × 1.88) + 71.85 White Female Estimated height (cm) = (knee height (cm) × 1.87) - (0.06 × age (y)) + 70.25
Time Frame
first day and last day ( end of the 28th day)
Title
weight
Description
We calculated the body weight of our patients by indirectly using the method of calculating body weight in bedridden patients.
Age (Year) 6-18 Male : (Knee length (cm) x 0.68) + (Arm circumference (cm)x 2.64) -50.08 Female : (Knee (cm) x 0.77) + (Arm (cm) x 2.47) - 50.16
19-59 Male : (Knee (cm) x 1.19) + (Arm (cm) x 3.21) -86.82 Female : (Knee (cm) x 1.01) + (Arm (cm) x 2.81) - 66.04
60-80 Male : (Knee (cm) x 1.10) + (Arm (cm) x 3.07) -75.81 Female : (Knee (cm) x 1.09) + (Arm circumference(cm) x 2.68) - 65.51
Time Frame
first day and last day (end of the 28th day)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Ondokuz Mayis University Faculty of Medicine
City
Samsun
State/Province
Atakum
ZIP/Postal Code
55200
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Is NMES Treatment in Sepsis/ Septic Shock Patients Protective in Development of ICU-AW?
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