This trial is active, not recruiting.

Conditions sepsis, mechanical ventilation
Treatments diaphragm muscle biopsy
Sponsor University Medical Center Nijmegen
Start date April 2010
End date April 2016
Trial size 30 participants
Trial identifier NCT01104857, Diam1


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose basic science
Patients admitted to the ICU meeting severe sepsis / septic shock criteria
diaphragm muscle biopsy
Biopsy is obtained for biochemical analysis
(Active Comparator)
diaphragm muscle biopsy
Biopsy is obtained for biochemical analysis

Primary Outcomes

Diaphragm muscle myosin content
time frame: 1 day
Markers for inflammation
time frame: 1 day
Markers for activation of proteolytic pathway in the diaphragm
time frame: 1 day

Secondary Outcomes

length of ICU stay
time frame: 6 months
Length of mechanical ventilation
time frame: 6 months

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

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

Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by University Medical Center Nijmegen.