MONITOR-IC: Determining and Improving Long-term Consequences of ICU Care

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16+
SponsorRadboud University Medical Center

About this trial

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).

The aims of this study are to study the: 1) long-term outcomes, 2) predictors for PICS, 3) prediction of long-term HRQoL, 4) ratio between HRQoL of ICU-survivors and healthcare related costs, and 5) effects on the long-term of interventions

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

Patients with a life expectancy of <48 hours;

receive palliative care;

are admitted for a donor procedure;

cannot read and speak the Dutch language;

Trial population

ICU patients admitted to one of the participating centers

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

50,000 Participants
are grouped into 1 trial group
Group A: Cohort

Trial outcomes

Primary outcomes

1

Health related quality of life

SF-12

Time frame
2-5 year post-ICU

Secondary outcomes

1

Health related quality of life

EQ5D-5L

Time frame
2 year post-ICU
2

Frailty as part of Physical-Cognitive-Mental impairments

CFS (Clinical Frailty Score)

Time frame
2 year post-ICU
3

Fatigue as part of Physical-Cognitive-Mental impairments

CIS-8 (Checklist Individual Strength)

Time frame
2 year post-ICU
4

Cognition as part of Physical-Cognitive-Mental impairments

CFQ-14

Time frame
2-5 year post-ICU

Other outcomes

Sponsors and contacts

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