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Clinical Trials/NCT01104857
NCT01104857
Unknown
Not Applicable

Respiratory Muscle Dysfunction in Critically Ill Patients

University Medical Center Nijmegen1 site in 1 country30 target enrollmentApril 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sepsis
Sponsor
University Medical Center Nijmegen
Enrollment
30
Locations
1
Primary Endpoint
Markers for inflammation
Last Updated
10 years ago

Overview

Brief Summary

Respiratory muscle dysfunction in critically ill patients is associated with elevated morbidity, including prolonged weaning from mechanical ventilation. The causes for respiratory muscle dysfunction in these patients is poorly understood and no effective treatment is available.

The general hypothesis of the present study is that in critically ill mechanically ventilated subjects respiratory muscle dysfunctions results from loss of myosin induced by activation of proteolytic cascades.

Registry
clinicaltrials.gov
Start Date
April 2010
End Date
April 2016
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Medical Center Nijmegen
Responsible Party
Principal Investigator
Principal Investigator

Leo Heunks

MD

University Medical Center Nijmegen

Eligibility Criteria

Inclusion Criteria

  • Severe sepsis / septic shock
  • Clinical reason for laparotomy
  • \> 18 years

Exclusion Criteria

  • No informed consent
  • Medical history of myopathy
  • Unintended weight loss before ICU admission
  • Pregnancy
  • Chronic use of corticosteroids

Outcomes

Primary Outcomes

Markers for inflammation

Time Frame: 1 day

Inflammatory mediators are measured in plasma and diaphragm at the moment the diaphragm biopsy is obtained.

Markers for activation of proteolytic pathway in the diaphragm

Time Frame: 1 day

Biochemical analysis is targeted towards activation of several proteolytic pathways (proteasome, lysosmal).

Diaphragm muscle myosin content

Time Frame: 1 day

Secondary Outcomes

  • length of ICU stay(6 months)
  • Length of mechanical ventilation(6 months)

Study Sites (1)

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