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Clinical Trials/NCT05572138
NCT05572138
Completed
Not Applicable

Body Impedance Analysis to Detect Muscle Strength Associated With ICU Acquired Weakness

Charite University, Berlin, Germany1 site in 1 country62 target enrollmentFebruary 8, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Critical Illness
Sponsor
Charite University, Berlin, Germany
Enrollment
62
Locations
1
Primary Endpoint
Correlation: Skeletal muscle mass and MRC-Score
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The aim of the study is to detect a value of muscle and organ mass measured by body impedance analysis and its correlation with the Medical Research Council (MRC) score. An MRC score ≤ 48 is defined as a diagnosis of ICU acquired weakness. The correlation of the values detected by BIA and their transfer to an MRC Score ≤ 48 will be investigated.

The knowledge gained will be used for early detection of ICUAW in order to reduce the consequences of the same.

Detailed Description

Intensive Care Unit Acquired Weakness (ICUAW) describes the clinically diagnosed manifestation of neuromuscular organ dysfunction. It develops in approximately 40% of all ICU patients, which corresponds to at least 1.2 million patients annually in Germany. All these patients face a wide spectrum of sequelae and increased mortality up to 5 years after ICU discharge. A characteristic pathophysiological phenomenon is early severe muscle atrophy, which is as high as 17% in the first days after ICU admission. ICUAW is currently diagnosed by the MRC score, which is assessed by the sum of manual muscle strength test results in 12 muscle groups (sum score). Manual muscle testing (MMT) is not possible during the early phase in critical illness in most patients due to coma, delirium, and/or injury. In addition, there is a possible discrepancy by different observers. As a result, early detection of ICUAW may be inadequate in most patients and unreliable during critical illness. Measurement by BIA is reproducible, so differences in measurement can be attributed to changes in clinical condition. Body impedance analysis thus demonstrates a means of objective measurement. Thus, the study aims to counteract the long-term consequences of ICUAW through early detection of ICUAW by allowing countermeasures to be taken earlier.

Registry
clinicaltrials.gov
Start Date
February 8, 2023
End Date
January 28, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Stefan J Schaller

Deputy Clinical Director

Charite University, Berlin, Germany

Eligibility Criteria

Inclusion Criteria

  • Patients aged ≥ 18 years with ventilatory support within 36 hours from ICU admission.

Exclusion Criteria

  • With a language barrier
  • Patients with pacemaker or other electronic implant
  • Expected death or discontinuation of life-sustaining measures.
  • Not walking independently before hospitalization (gait aids allowed)
  • Allergy to electrode gel
  • BIA or ultrasound not technically feasible due to e.g. extensive wounds, skin rash or bandages

Outcomes

Primary Outcomes

Correlation: Skeletal muscle mass and MRC-Score

Time Frame: till Day 30

The primary endpoint is the correlation between Skeletal muscle mass (SMM) measured by BIA and MRC score.

Secondary Outcomes

  • Correlation CSA and Skeletal muscle mass(till Day 30)
  • ICU-LOS(till Day 30 (till ICU discharge))
  • Kreatinin : MRC correlation(till Day 30)
  • IMS during the ICU stay(till Day 30 or ICU discharge)
  • UCR : MRC correlation(till Day 30)
  • ICU mortality(till Day 30)
  • Hospital mortality(till Day 30)
  • in-hospital mortality(till Day 30 (till hospital discharge))
  • Duration of Mechanical ventilation(till Day 30)
  • Hospital LOS(till Day 30 (till hospital discharge))

Study Sites (1)

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