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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pneumonia; Sepsis; Shock; Hemorrhage; Emergencies; Thrombosis; Frailty; Syncope; Urinary Tract Infections; Acute Kidney Injury; Acute Disease; Pulmonary Embolism; Dyspnea; Anaphylaxis; Polypharmacy; Complication of Treatment; Electrolyte Disturbance; Skin Infection; Intoxication by Drug

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])

• Study Type: Observational
• Enrollment (Anticipated): 35000

Contacts and Locations

• Study Contact: Name: Hjalmar Bouma, MD, PhD; Phone Number: +31 50 361 6161; Email: acutelines@umcg.nl

Study Locations

• Netherlands
  • Groningen, Netherlands, 9700 RB
    • Recruiting
    • University Medical Center Groningen
    • Contact: Hjalmar Bouma, MD, PhD; Phone Number: 0503616161; Email: acutelines@umcg.nl
    • Principal Investigator: Hjalmar Bouma, MD, PhD
    • Sub-Investigator: Ewoud ter Avest, MD, PhD
    • Sub-Investigator: Jan ter Maaten, MD, PhD
    • Sub-Investigator: Barbara van Munster, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomarkers	Laboratory values (Hb [mmol/L], leukocytes [/mL), trombocytes [/ml], creatinine [mmol/L], urea [mmol/L], CRP [mg/L], LDL cholesterol [mmol/L], HDL cholesterol [mmol/L], total cholesterol [mmol/L], AST [U/L], ALT [U/L], gGT [U/L], AF [U/L], bilirubin [microl/L], NTproBNP [pg/mL], troponin [microg/L]) will be retrieved from the electronic health records (EHR) from the hospital, general practitioner and pharmacy.	Up to 5 years
Medication use	Medication use will be retrieved from the electronic health records (EHR) from the hospital, general practitioner and pharmacy.	Up to 5 years
Treatment (non-pharmacological, including organ support)	Treatment (non-pharmacological) will be retrieved from the electronic health records (EHR) from the hospital, general practitioner and (helicopter) emergency medical service. Data will include intravenous fluid resuscitation, vasopressors, mechanical ventilation/non-invasive ventilation, oxygen supply, acute dialysis and extra-corporeal membrane oxygenation (ECMO)	Until hospital discharge, up to 3 months
Sequential organ failure assessment (SOFA)	SOFA scores will be available for patients admitted because of an infection.	Up to 72 hours after hospitalization
Vital parameters	Heart rate (bpm), blood pressure (mmHg), oxygen saturation (SpO2, SaO2, PaO2), breathing frequency (per min), consciousness (Glasgow coma scale), pain score (VAS), nausea/vomiting (y/n), defecation (y/n), urination (y/n), body weight (kg), length (cm), fluid balance (ml/day).	Until hospital discharge, up to 3 months

Collaborators and Investigators

• Sponsor: Hjalmar Bouma
• Investigators: Study Director: Ewoud ter Avest, MD, PhD, University Medical Center Groningen; Study Director: Jan ter Maaten, MD, PhD, University Medical Center Groningen; Study Chair: Barbara van Munster, MD, PhD, University Medical Center Groningen; Principal Investigator: Hjalmar Bouma, MD, PhD, University Medical Center Groningen

Publications and helpful links

General Publications

• 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.

Helpful Links

• Acutelines website UMCG

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2020
• Primary Completion (ANTICIPATED): September 1, 2030
• Study Completion (ANTICIPATED): September 1, 2030

Study Registration Dates

• First Submitted: October 18, 2020
• First Submitted That Met QC Criteria: November 3, 2020
• First Posted (ACTUAL): November 4, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 20, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Overcrowding; Biobank; Sepsis; Mortality; Outcome; Personalized medicine; Precision medicine; Acute disease; Hospitalization; Pharmacy; Emergency medicine; Multidisciplinary; Health insurance; Emergency Medical Service (EMS); General practitionar; Quality of life (QoL); Patient logistics; Point-of-care ultrasound (POCUS); Helicopter Emergency Medical Service (HEMS); Databank; Electrophysiological waveforms; Electrocardiogram (ECG); Plethysmogram
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Respiratory Tract Diseases; Immune System Diseases; Respiration Disorders; Lung Diseases; Kidney Diseases; Urologic Diseases; Hypersensitivity, Immediate; Neurologic Manifestations; Neurobehavioral Manifestations; Disease Attributes; Renal Insufficiency; Embolism and Thrombosis; Signs and Symptoms, Respiratory; Hypersensitivity; Unconsciousness; Consciousness Disorders; Emergencies; Embolism; Infections; Communicable Diseases; Hemorrhage; Frailty; Urinary Tract Infections; Acute Kidney Injury; Thrombosis; Syncope; Acute Disease; Pulmonary Embolism; Dyspnea; Anaphylaxis
• Other Study ID Numbers: 201900635

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data (IPD) may be available to other researchers if needed for their specific research purposes, which amongst others must be in line with the study protocol, the informed consent form and the general data protection regulations (GDPR). Each request for re-use of data will be reviewed by Acutelines' steering group, manager and local review board (LRb), prior to establishing a material and data transfer agreement (MDTA). No IPD will be shared if not required to answer research question.
• IPD Sharing Time Frame: Supporting information will become available short after initiation of the study and will remain available until the end of the study (undetermined).
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No