Respiratory Muscle Dysfunction in Critically Ill Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01104857
Recruitment Status : Unknown
Verified June 2015 by Leo Heunks, University Medical Center Nijmegen.
Recruitment status was:  Active, not recruiting
First Posted : April 16, 2010
Last Update Posted : June 10, 2015
Information provided by (Responsible Party):
Leo Heunks, University Medical Center Nijmegen

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.

Condition or disease Intervention/treatment Phase
Sepsis Mechanical Ventilation Procedure: diaphragm muscle biopsy Procedure: Diaphragm muscle biopsy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Study Start Date : April 2010
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Diaphragm muscle myosin content [ Time Frame: 1 day ]
  2. Markers for inflammation [ Time Frame: 1 day ]
    Inflammatory mediators are measured in plasma and diaphragm at the moment the diaphragm biopsy is obtained.

  3. 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 :
  1. length of ICU stay [ Time Frame: 6 months ]
    Length of ICU stay obtained from medical record

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

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01104857

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

Responsible Party: Leo Heunks, MD, University Medical Center Nijmegen Identifier: NCT01104857     History of Changes
Other Study ID Numbers: Diam1
First Posted: April 16, 2010    Key Record Dates
Last Update Posted: June 10, 2015
Last Verified: June 2015

Keywords provided by Leo Heunks, University Medical Center Nijmegen:
Respiratory muscle
Mechanical ventilation