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

NCT03246334 | Recruiting

• 1 other identifier: Radboudumc
• Study Type: observational
• Target: 50,000
• Locations: 1 country
• Sites: 1

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). 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

Conditions

Post-Intensive Care Syndrome (PICS)

Keywords

Cohort study; Critical Care; Follow-up study; Intensive care units; Long-term outcome; Outcome assessment; Quality of life

Outcome Measures

Primary Outcomes (1)

• Health related quality of life

  SF-12

  2-5 year post-ICU

Secondary Outcomes (8)

• Health related quality of life

  2 year post-ICU

• Frailty as part of Physical-Cognitive-Mental impairments

  2 year post-ICU

• Fatigue as part of Physical-Cognitive-Mental impairments

  2 year post-ICU

• Cognition as part of Physical-Cognitive-Mental impairments

  2-5 year post-ICU

• Anxiety and depression as part of Physical-Cognitive-Mental impairments

  2 year post-ICU

Study Arms (1)

Cohort

Critically ill patients admitted \>12 hours to the ICU

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ICU patients admitted to one of the participating centers

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboud university medical center

Nijmegen, 6500 HB, Netherlands

RECRUITING

Related Publications (8)

• Porter LL, Hazeleger L, Bos K, Simons KS, van der Hoeven JG, Yeghaian M, van der Woude MCE, van Santen S, Rettig TCD, de Vries M, van den Boogaard M, Zegers M. Identifying distinct clusters of ICU survivors by integrating demographic, pre-admission quality of life, and clinical data: a large prospective cohort study. Intensive Care Med. 2025 Sep;51(9):1603-1614. doi: 10.1007/s00134-025-08052-3. Epub 2025 Aug 7.

  PMID: 40773138 DERIVED

• Tilburgs B, Simons KS, Corsten S, Westerhof B, Rettig TCD, Ewalds E, Zegers M, van den Boogaard M. Associations Between Physical, Cognitive, and Mental Health Domains of Post-Intensive Care Syndrome and Quality of Life: A Longitudinal Multicenter Cohort Study. Crit Care Med. 2025 Jan 1;53(1):e74-e86. doi: 10.1097/CCM.0000000000006461. Epub 2024 Oct 24.

  PMID: 39445920 DERIVED

• Porter LL, Simons KS, Corsten S, Westerhof B, Rettig TCD, Ewalds E, Janssen I, Jacobs C, van Santen S, Slooter AJC, van der Woude MCE, van der Hoeven JG, Zegers M, van den Boogaard M. Changes in quality of life 1 year after intensive care: a multicenter prospective cohort of ICU survivors. Crit Care. 2024 Jul 25;28(1):255. doi: 10.1186/s13054-024-05036-5.

  PMID: 39054511 DERIVED

• van Sleeuwen D, Zegers M, Ramjith J, Cruijsberg JK, Simons KS, van Bommel D, Burgers-Bonthuis D, Koeter J, Bisschops LLA, Janssen I, Rettig TCD, van der Hoeven JG, van de Laar FA, van den Boogaard M. Prediction of Long-Term Physical, Mental, and Cognitive Problems Following Critical Illness: Development and External Validation of the PROSPECT Prediction Model. Crit Care Med. 2024 Feb 1;52(2):200-209. doi: 10.1097/CCM.0000000000006073. Epub 2023 Dec 15.

  PMID: 38099732 DERIVED

• Porter LL, Simons KS, Ramjith J, Corsten S, Westerhof B, Rettig TCD, Ewalds E, Janssen I, van der Hoeven JG, van den Boogaard M, Zegers M. Development and External Validation of a Prediction Model for Quality of Life of ICU Survivors: A Subanalysis of the MONITOR-IC Prospective Cohort Study. Crit Care Med. 2023 May 1;51(5):632-641. doi: 10.1097/CCM.0000000000005800. Epub 2023 Feb 20.

  PMID: 36825895 DERIVED

• Geense WW, de Graaf M, Vermeulen H, van der Hoeven J, Zegers M, van den Boogaard M. Reduced quality of life in ICU survivors - the story behind the numbers: A mixed methods study. J Crit Care. 2021 Oct;65:36-41. doi: 10.1016/j.jcrc.2021.05.008. Epub 2021 May 23.

  PMID: 34082253 DERIVED

• Geense W, Zegers M, Dieperink P, Vermeulen H, van der Hoeven J, van den Boogaard M. Changes in frailty among ICU survivors and associated factors: Results of a one-year prospective cohort study using the Dutch Clinical Frailty Scale. J Crit Care. 2020 Feb;55:184-193. doi: 10.1016/j.jcrc.2019.10.016. Epub 2019 Nov 5.

  PMID: 31739088 DERIVED

• Geense W, Zegers M, Vermeulen H, van den Boogaard M, van der Hoeven J. MONITOR-IC study, a mixed methods prospective multicentre controlled cohort study assessing 5-year outcomes of ICU survivors and related healthcare costs: a study protocol. BMJ Open. 2017 Nov 14;7(11):e018006. doi: 10.1136/bmjopen-2017-018006.

  PMID: 29138206 DERIVED

MeSH Terms

Conditions

postintensive care syndrome

Study Officials

• Mark van den Boogaard, RN, PhD.

  Radboud university medical center, Prof.dr. of Nursing Science in Acute and Critical Care

  PRINCIPAL INVESTIGATOR

• Marieke Zegers, PhD

  Radboud university medical center, Senior Researcher dep of Intensive Care Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark van den Boogaard, RN, PhD

CONTACT

0031-243665009; Mark.vandenBoogaard@radboudumc.nl

Marieke Zegers, PhD.

CONTACT

0031-243619269; Marieke.Zegers@radboudumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2017
• First Posted: August 11, 2017
• Study Start: July 1, 2016
• Primary Completion (Estimated): August 1, 2050
• Study Completion (Estimated): August 1, 2050
• Last Updated: December 27, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)