NCT01104857

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable sepsis

Timeline
Completed

Started Apr 2010

Longer than P75 for not_applicable sepsis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

April 12, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 16, 2010

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

June 10, 2015

Status Verified

June 1, 2015

Enrollment Period

6 years

First QC Date

April 12, 2010

Last Update Submit

June 9, 2015

Conditions

SepsisMechanical Ventilation

Keywords

Respiratory muscleMyosinMechanical ventilation

Outcome Measures

Primary Outcomes (3)

  • Diaphragm muscle myosin content

    1 day

  • Markers for inflammation

    Inflammatory mediators are measured in plasma and diaphragm at the moment the diaphragm biopsy is obtained.

    1 day

  • Markers for activation of proteolytic pathway in the diaphragm

    Biochemical analysis is targeted towards activation of several proteolytic pathways (proteasome, lysosmal).

    1 day

Secondary Outcomes (2)

  • length of ICU stay

    6 months

  • Length of mechanical ventilation

    6 months

Study Arms (2)

Diaphragm muscle biopsy

EXPERIMENTAL

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

Procedure: diaphragm muscle biopsy

Elective laparotomy

ACTIVE COMPARATOR
Procedure: Diaphragm muscle biopsy

Interventions

Diaphragm muscle biopsyPROCEDURE

Biopsy is obtained for biochemical analysis

Diaphragm muscle biopsy

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Severe sepsis / septic shock
  • Clinical reason for laparotomy
  • \> 18 years

You may not qualify if:

  • No informed consent
  • Medical history of myopathy
  • Unintended weight loss before ICU admission
  • Pregnancy
  • Chronic use of corticosteroids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud Universtity Nijmegen Medical Centre

Nijmegen, 6500HB, Netherlands

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 12, 2010

First Posted

April 16, 2010

Study Start

April 1, 2010

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

June 10, 2015

Record last verified: 2015-06

Locations

NL(1)