Acutelines: a Large Data-/Biobank of Acute and Emergency Medicine

NCT04615065 | Recruiting

• 1 other identifier: 201900635
• Study Type: observational
• Target: 35,000
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (16)

• Mortality (time and cause)

  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).

  Until the death of death from any cause, up to 50 years

• Katz ADL-6 (functioning)

  Katz ADL-6 (0-6, fully dependent-independent)

  Up to 1 year

• World Health Organization (WHO) performance status (functioning)

  World Health Organization (WHO) performance status (0-4, normal performance-bedridden)

  Up to 1 year

• Karnofsky performance score (functioning)

  Karnofsky performance score (10-100, moribund-normal performance)

  Up to 1 year

• Utrecht Activity List (daily activities)

  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 )

  Up to 1 year

• Short QUestionnaire to ASsess Health-enhancing physical activity (daily activities)

  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)

  Up to 1 year

• Quality of Life and experienced symptoms

  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)

  Up to 1 year

• Experienced somatic symptoms

  Patient Health Questionnaire-15 (PHQ-15; 0-30, minimal-high somatic symptom severity)

  Up to 1 year

• Fatigue

  Piper Fatigue Scale-12 (PFS-12; 0-10, higher scores reflect more fatigue among four subscales (a) behavior, (b) affect, (c) sensory, (d) cognition)

  Up to 1 year

• Patient Health Questionnaire-2 (mental health)

  Patient Health Questionnaire-2 (PHQ-2; 0-6, higher score corresponds to reduced mental health)

  Up to 1 year

• Patient Health Questionnaire-9 (mental health)

  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)

  Up to 1 year

• Geriatric Depression scale-15 (mental health)

  Geriatric Depression scale-15 (GDS-15; 0-4 no depressive symptoms, 5-10 mild depressive symptoms, 11-15 depressive symptoms)

  Up to 1 year

• Patient satisfaction

  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)

  Up to 1 year

• Decision making

  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)

  Up to 1 year

• Co-morbidity

  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)

  Up to 5 years

• Length-of-stay in hospital/intensive care unit (ICU)

  Length-of-stay in hospital and on intensive care unit (ICU) in days

  Until hospital discharge, an average of 2 weeks

Secondary Outcomes (5)

• Biomarkers

  Up to 5 years

• Medication use

  Up to 5 years

• Treatment (non-pharmacological, including organ support)

  Until hospital discharge, up to 3 months

• Sequential organ failure assessment (SOFA)

  Up to 72 hours after hospitalization

• Vital parameters

  Until hospital discharge, up to 3 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

RECRUITING

Related Publications (3)

• 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 DERIVED

• 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 DERIVED

• 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 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Biomaterials will be collected from: * Patients triaged as one of highest two triage categories (red or orange) according to the Manchester triage system; * Patients with shock; * Patients with a suspicion of sepsis (based on physicians' judgement, Sepsis-2 or Sepsis-3 criteria). Biomaterials to be collected are serum, plasma (EDTA), plasma (Lithium heparin), PAXGene RNA, buffy coat (from EDTA), urine, feces, hair

MeSH Terms

Conditions

Acute Disease; Sepsis; Pneumonia; Frailty; Pulmonary Embolism; Thrombosis; Acute Kidney Injury; Hemorrhage; Shock; Emergencies; Urinary Tract Infections; Cellulitis; Syncope; Anaphylaxis; Dyspnea; Crowding

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Skin Diseases, Infectious; Suppuration; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Spatial Behavior; Behavior

Study Officials

• Ewoud ter Avest, MD, PhD

  University Medical Center Groningen

  STUDY CHAIR

• Jan ter Maaten, MD, PhD

  University Medical Center Groningen

  STUDY DIRECTOR

• Hjalmar Bouma, MD, PhD

  University Medical Center Groningen

  STUDY DIRECTOR

Central Study Contacts

Hjalmar Bouma, MD, PhD

CONTACT

+31 50 361 6161; acutelines@umcg.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2020
• First Posted: November 4, 2020
• Study Start: September 1, 2020
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2030
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Supporting information will become available short after initiation of the study and will remain available until the end of the study (undetermined).
• Access Criteria: Supporting information will either be made available through the website (http://acutelines.umcg.nl), LinkedIn (https://www.linkedin.com/company/acutelines) and/or upon reasonable request.

Locations

NL (1)