NCT00882830

Brief Summary

The purpose of this study is to investigate the role of EMS as a preventive and therapeutic tool of CIPNM. The investigators hypothesized that EMS will prevent the development of CIPNM or have a beneficial role as a therapeutic means in case of CIPNM appearance.

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
52

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2007

Longer than P75 for phase_2

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

September 1, 2007

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 17, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
6.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

March 13, 2015

Status Verified

March 1, 2015

Enrollment Period

1.8 years

First QC Date

April 16, 2009

Last Update Submit

March 12, 2015

Conditions

Critical Illness Polyneuromyopathy (CIPNM)ICU Acquired Weakness (ICUAW)

Keywords

ICUmyopathyneuropathyEMScritical illness polyneuromyopathyNIRSmuscle biopsymicrodialysisCIPNM

Outcome Measures

Primary Outcomes (1)

  • Diagnosis of CIPNM

    June 2009

Secondary Outcomes (1)

  • Duration of weaning, time to ICU discharge, muscle mass preservation, muscle strength, muscle properties and structure.

    June 2011

Study Arms (2)

EMS group

EXPERIMENTAL
Procedure: EMS

control group

NO INTERVENTION

Interventions

EMSPROCEDURE

EMS sessions on both lower extremities (quadriceps and peroneus longus) simultaneously.

Also known as: Electrical muscle stimulation
EMS group

Eligibility Criteria

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

You may qualify if:

  • all patients admitted in ICU of Evaggelismos Hospital

You may not qualify if:

  • age \< 18 years
  • pregnancy
  • pre-existing neuromuscular disease (e.g. Gravis)
  • connective tissue disease
  • fractures or skin lesions that do not allow the implementation of EMS
  • BMI \> 35 kg/m2
  • brain death
  • terminal disease
  • length of stay \< 48 hours
  • presence of pacemaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Critical Care Unit, Evaggelismos Hospital, School of Medicine, University of Athens

Athens, 10676, Greece

Location

Related Publications (5)

  • Routsi C, Gerovasili V, Vasileiadis I, Karatzanos E, Pitsolis T, Tripodaki E, Markaki V, Zervakis D, Nanas S. Electrical muscle stimulation prevents critical illness polyneuromyopathy: a randomized parallel intervention trial. Crit Care. 2010;14(2):R74. doi: 10.1186/cc8987. Epub 2010 Apr 28.

    PMID: 20426834RESULT

  • Karatzanos E, Gerovasili V, Zervakis D, Tripodaki ES, Apostolou K, Vasileiadis I, Papadopoulos E, Mitsiou G, Tsimpouki D, Routsi C, Nanas S. Electrical muscle stimulation: an effective form of exercise and early mobilization to preserve muscle strength in critically ill patients. Crit Care Res Pract. 2012;2012:432752. doi: 10.1155/2012/432752. Epub 2012 Apr 1.

    PMID: 22545212RESULT

  • Gerovasili V, Stefanidis K, Vitzilaios K, Karatzanos E, Politis P, Koroneos A, Chatzimichail A, Routsi C, Roussos C, Nanas S. Electrical muscle stimulation preserves the muscle mass of critically ill patients: a randomized study. Crit Care. 2009;13(5):R161. doi: 10.1186/cc8123. Epub 2009 Oct 8.

    PMID: 19814793RESULT

  • Gerovasili V, Tripodaki E, Karatzanos E, Pitsolis T, Markaki V, Zervakis D, Routsi C, Roussos C, Nanas S. Short-term systemic effect of electrical muscle stimulation in critically ill patients. Chest. 2009 Nov;136(5):1249-1256. doi: 10.1378/chest.08-2888. Epub 2009 Aug 26.

    PMID: 19710290RESULT

  • Tzanis G, Vasileiadis I, Zervakis D, Karatzanos E, Dimopoulos S, Pitsolis T, Tripodaki E, Gerovasili V, Routsi C, Nanas S. Maximum inspiratory pressure, a surrogate parameter for the assessment of ICU-acquired weakness. BMC Anesthesiol. 2011 Jun 26;11:14. doi: 10.1186/1471-2253-11-14.

    PMID: 21703029RESULT

MeSH Terms

Conditions

Muscular Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Serafim Nanas, MD

    University of Athens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 16, 2009

First Posted

April 17, 2009

Study Start

September 1, 2007

Primary Completion

June 1, 2009

Study Completion

September 1, 2015

Last Updated

March 13, 2015

Record last verified: 2015-03

Locations

GR(1)