NCT03055949

Brief Summary

The purpose of this study is to determine whether an early rehabilitation program in surgical intensive care unit is safe and effective in preventing critical care illness and intensive care unit acquired weakness.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
131

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2014

Typical duration for not_applicable

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

May 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 16, 2017

Completed
Last Updated

February 16, 2017

Status Verified

February 1, 2017

Enrollment Period

1.8 years

First QC Date

January 15, 2017

Last Update Submit

February 14, 2017

Conditions

ICU-acquired Weakness

Keywords

early rehabilitationearly mobilizationsurgical intensive care unit

Outcome Measures

Primary Outcomes (2)

  • 28-day Ventilator-free days (days)

    Patients who died during the study were assigned scores of 0 for 28-day ventilator-free days.

    up to 28-day

  • 28-day ICU-free days (days)

    Patients who died during the study were assigned scores of 0 for 28-day ICU-free days

    up to 28-day

Secondary Outcomes (7)

  • Time to start rehabilitation from ICU admission (days)

    up to 2 weeks

  • ICU delirium days (days)

    up to 4 weeks

  • Total rehabilitation days within ICU days (days)

    up to 4 weeks

  • ICU readmission rate (%)

    up to 24 weeks

  • ICU mortality rate (%)

    up to 24 weeks

  • +2 more secondary outcomes

Study Arms (2)

pre-ERP

NO INTERVENTION

A group of the surgical ICU patients who had standard care before Asan medical center developed an early rehabilitation program (ERP)

post-ERP

EXPERIMENTAL

A group of the surgical ICU patients who had an early rehabilitation program (ERP) within SICU care

Behavioral: Early rehabilitation program

Interventions

Early rehabilitation programBEHAVIORAL

The investigators evaluated patients who were admitted SICU for more than 3 days for an early rehabilitation program and delivered one of 5-stepped rehabilitation program if the patient was eligible.

post-ERP

Eligibility Criteria

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

You may qualify if:

  • patients who were admitted in SICU for at least 3 days

You may not qualify if:

  • readmission to SICU within current hospitalization open abdomen wound patients major bone fracture patients brain death patients active bleeding patients increased intra-cranial pressure patients paraplegic patients patients or their guardians did not agree with the ERP doctor's decision (Deconditioning patients, Procedure)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Bailey P, Thomsen GE, Spuhler VJ, Blair R, Jewkes J, Bezdjian L, Veale K, Rodriquez L, Hopkins RO. Early activity is feasible and safe in respiratory failure patients. Crit Care Med. 2007 Jan;35(1):139-45. doi: 10.1097/01.CCM.0000251130.69568.87.

    PMID: 17133183RESULT

  • McWilliams D, Weblin J, Atkins G, Bion J, Williams J, Elliott C, Whitehouse T, Snelson C. Enhancing rehabilitation of mechanically ventilated patients in the intensive care unit: a quality improvement project. J Crit Care. 2015 Feb;30(1):13-8. doi: 10.1016/j.jcrc.2014.09.018. Epub 2014 Oct 2.

    PMID: 25316527RESULT

  • Morris PE, Goad A, Thompson C, Taylor K, Harry B, Passmore L, Ross A, Anderson L, Baker S, Sanchez M, Penley L, Howard A, Dixon L, Leach S, Small R, Hite RD, Haponik E. Early intensive care unit mobility therapy in the treatment of acute respiratory failure. Crit Care Med. 2008 Aug;36(8):2238-43. doi: 10.1097/CCM.0b013e318180b90e.

    PMID: 18596631RESULT

  • Schweickert WD, Pohlman MC, Pohlman AS, Nigos C, Pawlik AJ, Esbrook CL, Spears L, Miller M, Franczyk M, Deprizio D, Schmidt GA, Bowman A, Barr R, McCallister KE, Hall JB, Kress JP. Early physical and occupational therapy in mechanically ventilated, critically ill patients: a randomised controlled trial. Lancet. 2009 May 30;373(9678):1874-82. doi: 10.1016/S0140-6736(09)60658-9. Epub 2009 May 14.

    PMID: 19446324RESULT

Study Officials

  • Suk-kyung Hong, Ph.D.

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

January 15, 2017

First Posted

February 16, 2017

Study Start

May 1, 2014

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

February 16, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share