NCT00893633

Brief Summary

The aim of this research is to investigate critical illness neuromuscular abnormalities in neurocritical care patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
135

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2004

Typical duration 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

Study Start

First participant enrolled

March 1, 2004

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

May 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 6, 2009

Completed
Last Updated

July 10, 2009

Status Verified

July 1, 2009

Enrollment Period

2.8 years

First QC Date

May 5, 2009

Last Update Submit

July 9, 2009

Conditions

Muscle WeaknessCritical Illness

Keywords

neuromuscular diseasescritical illnessmechanical ventilationphrenic nervenerve conduction studies

Outcome Measures

Primary Outcomes (1)

  • incidence of critical illness neuromuscular abnormalities (CINMAs)

    within the first week of mechanical ventilation

Secondary Outcomes (3)

  • clinical and neurophysiological characteristics of CINMAs

    within the first week of mechanical ventilation

  • influence оf phrenic nerve pathology on weaning from mechanical ventilation

    during weaning period

  • dynamics of the neurophysiological characteristics of CINMAs

    during stay in ICU

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients from neurosurgical ICU in city clinical hospital

You may qualify if:

  • Age: 16 years and older
  • Acute primary cerebral pathology
  • Mechanical ventilation
  • Signs of systemic inflammatory response

You may not qualify if:

  • Brain stem or bilateral hemispheric lesions with tetraparesis at the onset of illness
  • Inability to perform high-grade nerve conduction studies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Institute of the Brain

Yekaterinburg, 620026, Russia

Location

MeSH Terms

Conditions

Muscle WeaknessCritical IllnessNeuromuscular Diseases

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsDisease Attributes

Study Officials

  • Andrey M Alasheev, MD, PhD

    Clinical Institute of the Brain, Russia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 5, 2009

First Posted

May 6, 2009

Study Start

March 1, 2004

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

July 10, 2009

Record last verified: 2009-07

Locations

RU(1)