Clinical trial NCT04615065: Acutelines: a Large Data-/Biobank of Acute and Emergency Medicine
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Disease
Sepsis
Pneumonia
Frailty
Complication of Treatment
Pulmonary Embolism
Thrombosis
Acute Kidney Injury
Electrolyte Disturbance
Hemorrhage
Shock
Polypharmacy
Intoxication by Drug
Emergencies
Urinary Tract Infections
Skin Infection
Syncope
Anaphylaxis
Dyspnea
Keywords: Acute disease
Sepsis
Emergency Medical Service (EMS)
Outcome
Precision medicine
Personalized medicine
Emergency medicine
Multidisciplinary
General practitionar
Pharmacy
Hospitalization
Health insurance
Mortality
Quality of life (QoL)
Overcrowding
Patient logistics
Point-of-care ultrasound (POCUS)
Helicopter Emergency Medical Service (HEMS)
Biobank
Databank
Electrophysiological waveforms
Electrocardiogram (ECG)
Plethysmogram
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2020-11-04
Enrollment: 35000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients admitted to the emergency room for emergency medicine, internal medicine \[including sub-specializations as allergology, acute medicine, oncology, hematology, infectiology, nephrology, vascular medicine, geriatric medicine\], pulmonology, gastro-enterology and rheumatology.

Brief summary: 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.

Detailed description: 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 \[ICU\])

Eligibility criteria: Inclusion Criteria, at least one of the following:

* Triaged as one of highest two triage categories (red or orange) according to the Manchester triage system;
* Triaged as the third highest triage category (yellow) and arrival by EMS of Helicopter Emergency Medical Service (HEMS;
* Shock
* Suspicion of sepsis (based on either physicians' suspicion, Sepsis-2 or Sepsis-3 criteria)
* Acute kidney injury (AKI)
* Anaphylactic reaction
* Syncope
* Intoxication
* Thrombosis
* Pulmonary embolism
* Bleeding while using anti-coagulant drugs
* Gastro-intestinal bleeding
* Electrolyte disturbance

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Mortality (time and cause)
timeFrame: Until the death of death from any cause, up to 50 years
measure: Katz ADL-6 (functioning)
timeFrame: Up to 1 year
measure: World Health Organization (WHO) performance status (functioning)
timeFrame: Up to 1 year
measure: Karnofsky performance score (functioning)
timeFrame: Up to 1 year
measure: Utrecht Activity List (daily activities)
timeFrame: Up to 1 year
measure: Short QUestionnaire to ASsess Health-enhancing physical activity (daily activities)
timeFrame: Up to 1 year
measure: Quality of Life and experienced symptoms
timeFrame: Up to 1 year
measure: Experienced somatic symptoms
timeFrame: Up to 1 year
measure: Fatigue
timeFrame: Up to 1 year
measure: Patient Health Questionnaire-2 (mental health)
timeFrame: Up to 1 year
measure: Patient Health Questionnaire-9 (mental health)
timeFrame: Up to 1 year
measure: Geriatric Depression scale-15 (mental health)
timeFrame: Up to 1 year
measure: Patient satisfaction
timeFrame: Up to 1 year
measure: Decision making
timeFrame: Up to 1 year
measure: Co-morbidity
timeFrame: Up to 5 years
measure: Length-of-stay in hospital/intensive care unit (ICU)
timeFrame: Until hospital discharge, an average of 2 weeks
Secondary outcomes:
measure: Biomarkers
timeFrame: Up to 5 years
measure: Medication use
timeFrame: Up to 5 years
measure: Treatment (non-pharmacological, including organ support)
timeFrame: Until hospital discharge, up to 3 months
measure: Sequential organ failure assessment (SOFA)
timeFrame: Up to 72 hours after hospitalization
measure: Vital parameters
timeFrame: Until hospital discharge, up to 3 months
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen
name: Ewoud ter Avest, MD, PhD
role: STUDY_CHAIR
affiliation: University Medical Center Groningen
name: Jan ter Maaten, MD, PhD
role: STUDY_DIRECTOR
affiliation: University Medical Center Groningen
name: Hjalmar Bouma, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Ter Avest E, van Munster BC, van Wijk RJ, Tent S, Ter Horst S, Hu TT, van Heijst LE, van der Veer FS, van Beuningen FE, Ter Maaten JC, Bouma HR. Cohort profile of Acutelines: a large data/biobank of acute and emergency medicine. BMJ Open. 2021 Jul 15;11(7):e047349. doi: 10.1136/bmjopen-2020-047349.