The Post-ICU Pain Study: a Multicenter, Prospective, Inception Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 2
- 主要终点
- Prevalence of pain
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult ICU patients ≥18 years of age
- •Acute admission to the ICU
- •ICU length of stay of at least 48 hours
排除标准
- •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.
结局指标
主要结局
Prevalence of pain
时间窗: 180 day follow-up
Patients are defined as having pain if they answer "yes" to question number 1 in the Brief Pain Inventory - Short Form
次要结局
- Brief Pain Inventory - Short Form (BPI-SF)(At follow-up at 90 and 180 days)
- Incidence of new-onset persistent pain after ICU discharge(at 90 and 180 days follow-up)
- Quality of life measured by EuroQol-5-domain 5-level (EQ-5D-5L)(at 90 and 180 days)
- The Single Item Sleep Quality Scale (SQS)(at 90 and 180 days)
- Hospital Anxiety and Depression Scale (HADS)(at 90 and 180 days)
- Self-Reported Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS)(90 and 180 days)
- 30-day mortality(30 days)
- 90-day mortality(90 days)
- 180 days mortality(180 days)