Understanding long-term effects of ICU care on patients
MONITOR-IC: a Mixed Methods Multicenter Prospective Open Cohort Study Determining and Improving Long-term Outcomes of ICU Survivors
This study looks at the long-term effects of ICU treatment on patients to see how it impacts their physical and mental health over several years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50000 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Radboud University Medical Center Academic / other |
| Locations | 1 site (Nijmegen) |
| Trial ID | NCT03246334 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the long-term consequences of intensive care unit (ICU) treatment, specifically focusing on post-intensive care syndrome (PICS). It will assess the physical, cognitive, and mental health outcomes of ICU survivors over a period of two to five years. The study will utilize traditional statistical methods and advanced AI/ML techniques to identify predictors of PICS and evaluate the relationship between health-related quality of life (HRQoL) and healthcare costs. Patients will be recruited from various ICUs across the Netherlands, including both academic and non-academic hospitals.
Who should consider this trial
Good fit: Ideal candidates include ICU patients aged 16 years or older who are admitted for at least 12 hours to specific types of ICUs.
Not a fit: Patients with a life expectancy of less than 48 hours or those receiving palliative care may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and interventions for enhancing the long-term quality of life for ICU survivors.
How similar studies have performed: Other studies have explored similar outcomes in ICU survivors, indicating a growing interest in understanding PICS, although this specific approach may offer novel insights.
Eligibility criteria
Show full inclusion / exclusion 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). 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.
Where this trial is running
Nijmegen
- Radboud university medical center — Nijmegen, Netherlands (Recruiting)
Study contacts
- Principal investigator: Mark van den Boogaard, RN, PhD. — Radboud university medical center, Prof.dr. of Nursing Science in Acute and Critical Care
- Study coordinator: Mark van den Boogaard, RN, PhD
- Email: Mark.vandenBoogaard@radboudumc.nl
- Phone: 0031-243665009
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.