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Respiratory Muscle Dysfunction in Critically Ill Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2015 by Leo Heunks, University Medical Center Nijmegen.
Recruitment status was:  Active, not recruiting
Information provided by (Responsible Party):
Leo Heunks, University Medical Center Nijmegen Identifier:
First received: April 12, 2010
Last updated: June 9, 2015
Last verified: June 2015

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.

Condition Intervention
Sepsis Mechanical Ventilation Procedure: diaphragm muscle biopsy Procedure: Diaphragm muscle biopsy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science

Resource links provided by NLM:

Further study details as provided by Leo Heunks, University Medical Center Nijmegen:

Primary Outcome Measures:
  • Diaphragm muscle myosin content [ Time Frame: 1 day ]
  • 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).

Secondary Outcome Measures:
  • length of ICU stay [ Time Frame: 6 months ]
    Length of ICU stay obtained from medical record

  • Length of mechanical ventilation [ Time Frame: 6 months ]
    Duration of mechanical ventilation is assesssed within 6 months after obtaining diaphragm biopsy.

Estimated Enrollment: 30
Study Start Date: April 2010
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diaphragm muscle biopsy
Patients admitted to the ICU meeting severe sepsis / septic shock criteria
Procedure: diaphragm muscle biopsy
Biopsy is obtained for biochemical analysis
Active Comparator: Elective laparotomy Procedure: Diaphragm muscle biopsy
Biopsy is obtained for biochemical analysis


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01104857

Radboud Universtity Nijmegen Medical Centre
Nijmegen, Netherlands, 6500HB
Sponsors and Collaborators
University Medical Center Nijmegen
  More Information

Responsible Party: Leo Heunks, MD, University Medical Center Nijmegen Identifier: NCT01104857     History of Changes
Other Study ID Numbers: Diam1
Study First Received: April 12, 2010
Last Updated: June 9, 2015

Keywords provided by Leo Heunks, University Medical Center Nijmegen:
Respiratory muscle
Mechanical ventilation processed this record on September 19, 2017