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

Overview

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 \[ICU\])

Primary outcome measures

• Mortality (time and cause) [Time frame: Until the death of death from any cause, up to 50 years]
• Katz ADL-6 (functioning) [Time frame: Up to 1 year]
• World Health Organization (WHO) performance status (functioning) [Time frame: Up to 1 year]
• Karnofsky performance score (functioning) [Time frame: Up to 1 year]
• Utrecht Activity List (daily activities) [Time frame: Up to 1 year]
• Short QUestionnaire to ASsess Health-enhancing physical activity (daily activities) [Time frame: Up to 1 year]
• Quality of Life and experienced symptoms [Time frame: Up to 1 year]
• Experienced somatic symptoms [Time frame: Up to 1 year]
• Fatigue [Time frame: Up to 1 year]
• Patient Health Questionnaire-2 (mental health) [Time frame: Up to 1 year]

Secondary outcome measures (5)

• Biomarkers [Time frame: Up to 5 years]
• Medication use [Time frame: Up to 5 years]
• Treatment (non-pharmacological, including organ support) [Time frame: Until hospital discharge, up to 3 months]
• Sequential organ failure assessment (SOFA) [Time frame: Up to 72 hours after hospitalization]
• Vital parameters [Time frame: Until hospital discharge, up to 3 months]

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.

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

Netherlands · 1 center

• University Medical Center Groningen — Groningen

Publications

• van der Aart TJ, Luxen M, Koeze J, Londen MV, Hackl M, Ter Maaten JC, van Meurs M, Bouma HR; the Acutelines research group. Validation of plasma microRNAs as biomarkers in sepsis associated acute kidney injury upon first clinical presentation reveals limited diagnostic and prognostic performance. PLoS One. 2025 Sep 4;20(9):e0331442. doi: 10.1371/journal.pone.0331442. eCollection 2025. PMID 40906653
• van der Aart TJ, Visser M, van Londen M, van de Wetering KMH, Ter Maaten JC, Bouma HR; Acutelines research group. The smell of sepsis: Electronic nose measurements improve early recognition of sepsis in the ED. Am J Emerg Med. 2025 Feb;88:126-133. doi: 10.1016/j.ajem.2024.11.045. Epub 2024 Nov 26. PMID 39615435
• 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. PMID 34266842

Identifiers

NCT: NCT04615065 · 201900635

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗