Post-ICU persistent pain in survivors
The Post-ICU Pain Study: a Multicenter, Prospective, Inception Cohort Study
This study will try to find how common and what causes long-lasting pain in adults who spent at least 48 hours in an ICU in Denmark.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 800 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Zealand University Hospital Academic / other |
| Locations | 4 sites (Aalborg and 3 other locations) |
| Trial ID | NCT07180407 on ClinicalTrials.gov |
What this trial studies
This is a multicenter, prospective inception cohort of adult ICU survivors in Denmark designed to follow clinical trajectories of persistent pain and related symptoms. The study plans to enroll about 800 acute ICU patients with stays of 48 hours or more from participating hospitals. Participants will be contacted by telephone at 90 and 180 days after ICU discharge and complete standardized questionnaires on pain, sleep, mood, and quality of life. The design aims to identify risk factors and pathophysiologic signals while excluding planned postoperative admissions and patients unable to complete Danish-language questionnaires.
Who should consider this trial
Good fit: Adults aged 18 or older who were acutely admitted to a participating Danish ICU and stayed at least 48 hours and who can complete questionnaires in Danish are ideal candidates.
Not a fit: Patients admitted after planned elective surgery, those transferred from non-participating ICUs, or those unable to complete Danish questionnaires (including severe cognitive deficits) are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the findings could help clinicians identify ICU survivors at high risk for long-term pain and inform follow-up and treatment strategies.
How similar studies have performed: Previous research has documented persistent pain in ICU survivors but results have been conflicting and contemporary data from Danish ICUs are lacking.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult ICU patients ≥18 years of age * Acute admission to the ICU * ICU length of stay of at least 48 hours Exclusion Criteria: * Patients transferred from a non-participating ICU * Patients with pre-planned admission to the ICU e.g., following elective surgery * Patients unable to complete questionnaires, including those who are unable to understand or speak Danish, or patients with severe cognitive deficits.
Where this trial is running
Aalborg and 3 other locations
- Aalborg University Hospital — Aalborg, Denmark (Not_yet_recruiting)
- Zealand University Hospital — Køge, Denmark (Recruiting)
- Zealand University Hospital — Nykøbing Falster, Denmark (Recruiting)
- Zealand University Hospital — Roskilde, Denmark (Recruiting)
Study contacts
- Study coordinator: Bennedikte K Madsen, MD
- Email: bkom@regionsjaelland.dk
- Phone: 0045
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.