Respiratory Muscle Dysfunction in Critically Ill Patients

University Medical Center Nijmegen

Status: Unknown

Conditions: Mechanical Ventilation; Sepsis

Treatments: Procedure: Diaphragm muscle biopsy; Procedure: diaphragm muscle biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT01104857

Diam1

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Diaphragm muscle biopsy

Experimental group

Description:

Patients admitted to the ICU meeting severe sepsis / septic shock criteria

Treatment:

Procedure: diaphragm muscle biopsy

Elective laparotomy

Active Comparator group

Treatment:

Procedure: Diaphragm muscle biopsy