Respiratory Muscle Dysfunction in Critically Ill Patients

Sepsis Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01104857
• Other study ID #: Diam1
• Status: Active, not recruiting
• Phase: N/A
• First received: April 12, 2010
• Last updated: June 9, 2015
• Start date: April 2010
• Est. completion date: April 2016

Study information

• Verified date: June 2015
• Source: University Medical Center Nijmegen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Mechanical Ventilation
• Sepsis

Intervention

Procedure:
• diaphragm muscle biopsy
Biopsy is obtained for biochemical analysis
• Diaphragm muscle biopsy
Biopsy is obtained for biochemical analysis

Locations

Country	Name	City	State
Netherlands	Radboud Universtity Nijmegen Medical Centre	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Nijmegen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diaphragm muscle myosin content		1 day	No
Primary	Markers for inflammation	Inflammatory mediators are measured in plasma and diaphragm at the moment the diaphragm biopsy is obtained.	1 day	No
Primary	Markers for activation of proteolytic pathway in the diaphragm	Biochemical analysis is targeted towards activation of several proteolytic pathways (proteasome, lysosmal).	1 day	No
Secondary	length of ICU stay	Length of ICU stay obtained from medical record	6 months	No
Secondary	Length of mechanical ventilation	Duration of mechanical ventilation is assesssed within 6 months after obtaining diaphragm biopsy.	6 months	No