Respiratory Muscle Dysfunction in Critically Ill Patients

NCT ID: NCT01104857

Last Updated: 2015-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2016-04-30

Brief Summary

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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

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Conditions

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Sepsis Mechanical Ventilation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Diaphragm muscle biopsy

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

Group Type EXPERIMENTAL

diaphragm muscle biopsy

Intervention Type PROCEDURE

Biopsy is obtained for biochemical analysis

Elective laparotomy

Group Type ACTIVE_COMPARATOR

Diaphragm muscle biopsy

Intervention Type PROCEDURE

Biopsy is obtained for biochemical analysis

Interventions

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diaphragm muscle biopsy

Biopsy is obtained for biochemical analysis

Intervention Type PROCEDURE

Diaphragm muscle biopsy

Biopsy is obtained for biochemical analysis

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Center Nijmegen

OTHER

Sponsor Role lead

Responsible Party

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Leo Heunks

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Radboud Universtity Nijmegen Medical Centre

Nijmegen, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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Diam1

Identifier Type: -

Identifier Source: org_study_id

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