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MONITOR-IC: Determining Long-term Consequences of ICU Care (MONITOR-IC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03246334
Recruitment Status : Recruiting
First Posted : August 11, 2017
Last Update Posted : August 15, 2017
Sponsor:
Information provided by (Responsible Party):
Radboud University

Brief Summary:

Due to advances in critical care medicine, more patients survive their critical illness. However, intensive care unit (ICU) survivors often experience long-term physical, cognitive and mental problems, summarized as post intensive care syndrome (PICS), impacting their health related quality of life (HRQoL). In what frequency PICS occurs, and to what extent this influences ICU survivors' HRQoL, is mostly unknown.

The aims of this study are therefore to study the: 1) five-year patient outcomes, 2) predictors for PICS, 3) ratio between HRQoL of ICU-survivors and healthcare related costs, and 4) care and support needs.


Condition or disease
Post Intensive Care Syndrome (PICS)

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Study Type : Observational
Estimated Enrollment : 12000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: MONITOR-IC: a Mixed Methods Multicenter Prospective Controlled Cohort Study Determining the Five-year Outcomes of ICU Survivors
Actual Study Start Date : July 1, 2016
Estimated Primary Completion Date : August 2026
Estimated Study Completion Date : August 2026

Group/Cohort
Cohort
Case group: critically ill patients admitted >12 hours to the ICU. Control group: critically ill patients to the ICU <12 hrs, or to Post Anaesthesia Care Unit (PACU), or Medium Care or High Dependency Unit.



Primary Outcome Measures :
  1. Health related quality of life [ Time Frame: ICU discharge - 5 year follow up ]
    SF-36


Secondary Outcome Measures :
  1. Health related quality of life [ Time Frame: ICU admission- 5 year follow up ]
    EQ5D-5L

  2. Frailty as part of Physical-Cognitive-Mental impairments [ Time Frame: ICU admission- 5 year follow up ]
    CFS (Clinical Frailty Score)

  3. Fatigue as part of Physical-Cognitive-Mental impairments [ Time Frame: ICU admission- 5 year follow up ]
    CIS-8 (Checklist Individual Strength)

  4. Cognition as part of Physical-Cognitive-Mental impairments [ Time Frame: ICU admission- 5 year follow up ]
    CFQ-14

  5. Anxiety and depression as part of Physical-Cognitive-Mental impairments [ Time Frame: ICU admission- 5 year follow up ]
    HADS (Hospital Anxiety and Depression Scale)

  6. Post traumatic stress disorder as part of Physical-Cognitive-Mental impairments [ Time Frame: ICU admission- 5 year follow up ]
    IES-R (Impact of Event Scale Revised)

  7. Patients' care and support needs and social consequences [ Time Frame: ICU admission- 5 year follow up ]
    Questionnaire regarding specific needs and supports and social impact post ICU

  8. Patients' healthcare use and related costs [ Time Frame: ICU admission- 5 year follow up ]
    Data of healthcare insurance



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
ICU patients admitted to one of the participating centers
Criteria

Inclusion Criteria:

  • ICU patients age 16 years or older;
  • admitted at least 12 hours to a trauma, medical, neurosurgery or cardiac surgery ICU;
  • gave written informed consent (or by their legal representative).
  • for the control group: admitted either to the ICU <12 hours, or to the Post Anaesthesia Care Unit (PACU), the Medium Care or High Dependency Unit for instance for monitoring during short interventions, such as bronchoalveolar lavage or insertion of a central venous catheter.

Exclusion Criteria:

  • Patients with a life expectancy of <48 hours;
  • receive palliative care;
  • are admitted for a donor procedure;
  • cannot read and speak the Dutch language;
  • or are not able to fill in the questionnaire and do not have family members/ legal representatives either.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03246334


Contacts
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Contact: Mark van den Boogaard, RN, PhD 0031-243665009 Mark.vandenBoogaard@radboudumc.nl
Contact: Marieke Zegers, PhD. 0031-243653881 Marieke.Zegers@radboudumc.nl

Locations
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Netherlands
Radboud university medical center Recruiting
Nijmegen, Netherlands, 6500 HB
Contact: Mark van den Boogaard, RN, PhD.    0031-243665009    Mark.vandenBoogaard@radboudumc.nl   
Contact: Marieke Zegers, PhD.    0031-243653881    Marieke.Zegers@radboudumc.nl   
Sponsors and Collaborators
Radboud University
Investigators
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Principal Investigator: Hans van der Hoeven, MD, PhD. Radboud university medical center, head of dep. Intensive Care Medicine
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT03246334    
Other Study ID Numbers: Radboudumc
First Posted: August 11, 2017    Key Record Dates
Last Update Posted: August 15, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Radboud University:
Cohort study
Critical Care
Follow-up study
Intensive care units
Long-term outcome
Outcome assessment
Quality of life