NCT03184623

Brief Summary

ICUacquired weakness is a common complication of critical illness, particularly in patients receiving mechanical ventilation and/or suffering from conditions leading to the systemic inflammatory response syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

June 9, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

June 9, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 12, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2017

Completed
Last Updated

September 8, 2017

Status Verified

September 1, 2017

Enrollment Period

3 months

First QC Date

June 9, 2017

Last Update Submit

September 5, 2017

Conditions

Muscle Loss

Outcome Measures

Primary Outcomes (1)

  • change in muscle mass measurements during ICU stay

    measurement by echography

    baseline, day 2 and day 5

Interventions

muscle mass measurementOTHER

measurement of muscle mass by echocardiography

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients admitted to the ICU with an expected lenght of stay \> 48 hours

You may qualify if:

  • all acute admitted patients in ICU

You may not qualify if:

  • age \< 18
  • stay on ICU \< 48 hours
  • use of corticosteroids
  • neurological diseases
  • acute kidney injure / nead of CVVH

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Center Leeuwarden

Leeuwarden, 8934AD, Netherlands

Location

MeSH Terms

Conditions

Muscular Atrophy

Condition Hierarchy (Ancestors)

Neuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Matty Koopmans, MSc

    MCL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research coordinator

Study Record Dates

First Submitted

June 9, 2017

First Posted

June 12, 2017

Study Start

June 9, 2017

Primary Completion

September 5, 2017

Study Completion

September 5, 2017

Last Updated

September 8, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)