Respiratory Muscle Dysfunction in Critically Ill Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by University Medical Center Nijmegen.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University Medical Center Nijmegen
ClinicalTrials.gov Identifier:
NCT01104857
First received: April 12, 2010
Last updated: April 16, 2010
Last verified: April 2010
  Purpose

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: Open Label
Primary Purpose: Basic Science

Resource links provided by NLM:


Further study details as provided by University Medical Center Nijmegen:

Primary Outcome Measures:
  • Diaphragm muscle myosin content [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Markers for inflammation [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Biochemical analysis is targeted towards activation of several proteolytic pathways (proteasome, lysosmal).


Secondary Outcome Measures:
  • length of ICU stay [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Length of ICU stay obtained from medical record

  • Length of mechanical ventilation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 2011
Estimated Primary Completion Date: April 2011 (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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01104857

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

No publications provided

Responsible Party: Leo Heunks, Radboud University Medical Centre Nijmegen
ClinicalTrials.gov Identifier: NCT01104857     History of Changes
Other Study ID Numbers: Diam1
Study First Received: April 12, 2010
Last Updated: April 16, 2010
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by University Medical Center Nijmegen:
Respiratory muscle
Myosin
Mechanical ventilation

Additional relevant MeSH terms:
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on April 15, 2014