Acutelines: a Large Biobank Aiming to Improve Early Recognition of Acute Diseases, Contribute to the Development of Personalized Medicine and Optimize Short- and Long-term Outcome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 35,000
- 试验地点
- 1
- 主要终点
- Mortality (time and cause)
研究概览
简要总结
Research in acute care faces many challenges, including enrollment challenges, legal limitations in data sharing, limited funding, and lack of singular ownership of the domain of acute care. To overcome some of these challenges, the Center of Acute Care of the University Medical Center Groningen in the Netherlands, has established a de novo data-, image- and biobank named "Acutelines". Acutelines is initiated to improve recognition and treatment of acute diseases and obtain insight in the consequences of acute diseases, including factors predicting its outcome. Thereby, Acutelines contributes to development of personalized treatment and improves prediction of patient outcomes after an acute admission.
详细描述
Acutelines is a prospective biobank including patients with a broad spectrum of acute conditions. Its aim is to facilitate interdisciplinary research on the etiology and development of acute diseases with the aid of systematically collected biomaterials and medical data over various timepoints, both during the course of the patient's disease and after recovery. Clinical data, imaging data and biomaterial (i.e. blood, urine, feces, hair) are collected for patients presenting to the Emergency Department (ED) with a broad range of acute disease presentations. A deferred consent procedure (by proxy), is in place to allow collecting data and biomaterials prior to obtaining written consent. The digital infrastructure in place and the software used ensures automated capturing of all bed-side monitoring data (i.e. electrophysiological waveforms, vital parameters), and the secure importation of data from other sources, such as the electronic health records of the hospital, ambulance and general practitioner, municipal registration, health insurance companies and pharmacy. Follow up data are collected for all included patients during the first 72-hours of their hospitalization and 3-months, 1-year, 2-years and 5 years after their ED visit.
Data and materials to be collected includes:
- Demographic and health data (i.e. [experiences] health, quality of life, functional status)
- Medical history (i.e. co-morbidity, intoxications, medication use)
- Admission reason to emergency department
- Physical examination and vital parameters
- Clinical diagnostic data (i.e. [point-of-care] ultrasound, X-ray, CT-scan, laboratory results)
- Electrophysiological waveforms (i.e. electrocardiogram [ECG], plethysmography)
- Biomaterials
- Treatment (i.e. medication use, non-pharmacological treatment, treatment decisions, length-of-stay in hospital, admission to intensive care unit [ICU])
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
- 未提供
排除标准
- •Referred for organ transplantation as recipient
- •Transfer from other hospital
- •Accidental contact patient material (i.e. internal work-related accident)
- •While data- and imaging will be collected from all these patients, biomaterials will only be collected from patients fulfilling the first criterion (i.e. triaged as one of highest two triage categories [red or orange] according to the Manchester triage system) and from patients with shock or a suspicion of sepsis.
结局指标
主要结局
Mortality (time and cause)
时间窗: Until the death of death from any cause, up to 50 years
Mortality will be retrieved from the electronic health records (EHR) from the hospital and municipal registration. The cause of death will be retrieved from the EHR from the hospital, general practitioner and Dutch statistics' office (CBS).
Utrecht Activity List (daily activities)
时间窗: Up to 1 year
Utrecht Activity List (UAL; hours/week spend on (a) paid work, (b) education, (c) household, (d) running errands, (e) unpaid work, (f) sport, (g) hobbies, (h) other use of leisure time )
Short QUestionnaire to ASsess Health-enhancing physical activity (daily activities)
时间窗: Up to 1 year
Short QUestionnaire to ASsess Health-enhancing physical activity (SQUASH; minutes/week and intensity of activity spend (a) commuting, (b) at work, (c) household activities and (d) leisure time; increased score corresponds with increased physical activity)
Patient satisfaction
时间窗: Up to 1 year
Patient Satisfaction Questionnaire Short-form (PSQ-18; measuring general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with doctor, and accessibility and convenience; scored per domain, with lower scores corresponding with higher satisfaction)
Katz ADL-6 (functioning)
时间窗: Up to 1 year
Katz ADL-6 (0-6, fully dependent-independent)
Karnofsky performance score (functioning)
时间窗: Up to 1 year
Karnofsky performance score (10-100, moribund-normal performance)
Fatigue
时间窗: Up to 1 year
Piper Fatigue Scale-12 (PFS-12; 0-10, higher scores reflect more fatigue among four subscales (a) behavior, (b) affect, (c) sensory, (d) cognition)
World Health Organization (WHO) performance status (functioning)
时间窗: Up to 1 year
World Health Organization (WHO) performance status (0-4, normal performance-bedridden)
Quality of Life and experienced symptoms
时间窗: Up to 1 year
EuroQol-5D (EQ5D; simple descriptive profile and a single index value for health status; higher values corresponding with better health) with visual analogue scale (VAS; 0-100, worse-best experienced health)
Experienced somatic symptoms
时间窗: Up to 1 year
Patient Health Questionnaire-15 (PHQ-15; 0-30, minimal-high somatic symptom severity)
Decision making
时间窗: Up to 1 year
Outcome prioritization tool (OPT; 0-100% per domain of prioritization for (a) life extension, (b) preserving independence, (c) reducing pain and (d) reducing other symptoms)
Patient Health Questionnaire-2 (mental health)
时间窗: Up to 1 year
Patient Health Questionnaire-2 (PHQ-2; 0-6, higher score corresponds to reduced mental health)
Patient Health Questionnaire-9 (mental health)
时间窗: Up to 1 year
Patient Health Questionnaire-9 (PHQ-9; 0-4 no depressive symptoms, 5-9 mild depressive symptoms, 10-14 moderate depressive symptoms, 15-19 moderately severe depressive symptoms, 20-27 severe depressive symptoms)
Geriatric Depression scale-15 (mental health)
时间窗: Up to 1 year
Geriatric Depression scale-15 (GDS-15; 0-4 no depressive symptoms, 5-10 mild depressive symptoms, 11-15 depressive symptoms)
Length-of-stay in hospital/intensive care unit (ICU)
时间窗: Until hospital discharge, an average of 2 weeks
Length-of-stay in hospital and on intensive care unit (ICU) in days
Co-morbidity
时间窗: Up to 5 years
Co-morbidity will be retrieved from the electronic health records (EHR) from the hospital, general practitioner and pharmacy. Data will be registered according to the Charlson' co-morbidity index (CCI; 1-2 mild co-morbidity, 3-4 moderate co-morbidity, 5 severe co-morbidity)
次要结局
- Sequential organ failure assessment (SOFA)(Up to 72 hours after hospitalization)
- Medication use(Up to 5 years)
- Vital parameters(Until hospital discharge, up to 3 months)
- Biomarkers(Up to 5 years)
- Treatment (non-pharmacological, including organ support)(Until hospital discharge, up to 3 months)