Respiratory Muscle Dysfunction in Critically Ill Patients

Not Applicable

• Conditions: Mechanical Ventilation; Sepsis
• Interventions: Procedure: Diaphragm muscle biopsy

• Registration Number: NCT01104857
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-12
• Study First Submitted QC: 2010-04-14
• Study First Posted: 2010-04-16
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-09
• Last Update Posted: 2015-06-10
• Primary Completion: 2016-04
• Study Completion: 2016-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diaphragm muscle biopsy	Diaphragm muscle biopsy	Patients admitted to the ICU meeting severe sepsis / septic shock criteria
Elective laparotomy	Diaphragm muscle biopsy	-

Primary Outcome Measures

Name	Time	Method
Markers for inflammation	1 day	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	1 day	Biochemical analysis is targeted towards activation of several proteolytic pathways (proteasome, lysosmal).
Diaphragm muscle myosin content	1 day

Secondary Outcome Measures

Name	Time	Method
length of ICU stay	6 months	Length of ICU stay obtained from medical record
Length of mechanical ventilation	6 months	Duration of mechanical ventilation is assesssed within 6 months after obtaining diaphragm biopsy.

Trial Locations

Locations (1)

Radboud Universtity Nijmegen Medical Centre; 🇳🇱 Nijmegen, Netherlands