Respiratory Muscle Dysfunction in Critically Ill Patients

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01104857

Enrollment

Registered

2010-04-16

Start date

2010-04-30

Completion date

2016-04-30

Last updated

2015-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mechanical Ventilation, Sepsis

Keywords

Respiratory muscle, Myosin, Mechanical ventilation

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.

Interventions

PROCEDUREdiaphragm muscle biopsy

Biopsy is obtained for biochemical analysis

PROCEDUREDiaphragm muscle biopsy

Biopsy is obtained for biochemical analysis

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Diaphragm muscle myosin content	1 day	—
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).

Secondary

Measure	Time frame	Description
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.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026