The Post-ICU Pain Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Chronic Pain, Post Intensive Care Unit Syndrome, Quality of Life, Pain Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Post-ICU Pain Study: a Multicenter, Prospective, Inception Cohort Study
Overview
BACKGROUND: ICU survivors may experience serious psychological, physical and cognitive impairments following ICU admission, collectively termed Post Intensive Care Syndrome (PICS). Persistent pain is an underrecognized component of PICS. Previous research has shown that persistent pain is a profound clinical challenge in ICU survivors, however, research demonstrates conflicting results. Furthermore, no studies have examined the prevalence of persistent pain in ICU survivors in a contemporary Danish ICU setting. OBJECTIVES: We aim to examine the clinical trajectory, risk factors, and pathophysiology of persistent pain in ICU survivors in Denmark. DESIGN AND SAMPLE SIZE: The study is designed as a multicenter, prospective, inception cohort study with clinical follow-up. Based on the pre-study sample size calculation, 800 patients will be included. Patients will be contacted by telephone 90 days and 180 days after ICU discharge, and a series of questionnaires regarding pain, sleep quality, affective state and quality of life will be completed. A subgroup of patients will undergo a detailed clinical examination including quantitative sensory testing between 180-365 days after ICU discharge. POPULATION: Patients will be recruited from 4 Danish ICU departments. Inclusion criteria include adult patients (18 years of age), acute admission to the ICU, and an ICU admission of a minimum of 48 hours. OUTCOMES: The primary outcome is the prevalence of pain assessed by the Brief Pain Inventory (BPI) at 90 and 180 days after ICU discharge. Secondary outcomes include additional detailed descriptions of pain and daily activity, sleep quality, affective state, quality of life, treatment- and patient-related risk factors, and biomarkers associated with development of persistent pain. Substudies: \- QST substudy: 80 participants (40 with pain and 40 without pain) recruited from the main cohort will undergo Quantative Somatosensory Testing (QST). The objectives are first, to delineate somatosensory profiles of ICU survivors with and without pain, and second, to examine the presence of neuropathic pain in ICU survivors.
Primary outcome measures
- Prevalence of pain [Time frame: 180 day follow-up]
Secondary outcome measures (9)
- Brief Pain Inventory - Short Form (BPI-SF) [Time frame: At follow-up at 90 and 180 days]
- Incidence of new-onset persistent pain after ICU discharge [Time frame: at 90 and 180 days follow-up]
- Quality of life measured by EuroQol-5-domain 5-level (EQ-5D-5L) [Time frame: at 90 and 180 days]
- The Single Item Sleep Quality Scale (SQS) [Time frame: at 90 and 180 days]
- Hospital Anxiety and Depression Scale (HADS) [Time frame: at 90 and 180 days]
- Self-Reported Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) [Time frame: 90 and 180 days]
- 30-day mortality [Time frame: 30 days]
- 90-day mortality [Time frame: 90 days]
- 180 days mortality [Time frame: 180 days]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Denmark · 4 centers
- Aalborg University Hospital — Aalborg
- Zealand University Hospital — Køge
- Zealand University Hospital — Nykøbing Falster
- Zealand University Hospital — Roskilde
Identifiers
NCT: NCT07180407 · PIP-study