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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04615065
Acronym
Acutelines
Enrollment
35000
Registered
2020-11-04
Start date
2020-09-01
Completion date
2030-09-01
Last updated
2024-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

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 \[ICU\])

Interventions

None listed

Sponsors

University Medical Center Groningen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Length-of-stay in hospital/intensive care unit (ICU)Until hospital discharge, an average of 2 weeksLength-of-stay in hospital and on intensive care unit (ICU) in days
Patient Health Questionnaire-9 (mental health)Up to 1 yearPatient 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)Up to 1 yearGeriatric Depression scale-15 (GDS-15; 0-4 no depressive symptoms, 5-10 mild depressive symptoms, 11-15 depressive symptoms)
Patient satisfactionUp to 1 yearPatient 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)
Decision makingUp to 1 yearOutcome prioritization tool (OPT; 0-100% per domain of prioritization for (a) life extension, (b) preserving independence, (c) reducing pain and (d) reducing other symptoms)
Co-morbidityUp to 5 yearsCo-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)
Mortality (time and cause)Until the death of death from any cause, up to 50 yearsMortality 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).
Katz ADL-6 (functioning)Up to 1 yearKatz ADL-6 (0-6, fully dependent-independent)
World Health Organization (WHO) performance status (functioning)Up to 1 yearWorld Health Organization (WHO) performance status (0-4, normal performance-bedridden)
Karnofsky performance score (functioning)Up to 1 yearKarnofsky performance score (10-100, moribund-normal performance)
Utrecht Activity List (daily activities)Up to 1 yearUtrecht 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)Up to 1 yearShort 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)
Quality of Life and experienced symptomsUp to 1 yearEuroQol-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 symptomsUp to 1 yearPatient Health Questionnaire-15 (PHQ-15; 0-30, minimal-high somatic symptom severity)
FatigueUp to 1 yearPiper Fatigue Scale-12 (PFS-12; 0-10, higher scores reflect more fatigue among four subscales (a) behavior, (b) affect, (c) sensory, (d) cognition)
Patient Health Questionnaire-2 (mental health)Up to 1 yearPatient Health Questionnaire-2 (PHQ-2; 0-6, higher score corresponds to reduced mental health)

Secondary

MeasureTime frameDescription
Medication useUp to 5 yearsMedication use will be retrieved from the electronic health records (EHR) from the hospital, general practitioner and pharmacy.
Treatment (non-pharmacological, including organ support)Until hospital discharge, up to 3 monthsTreatment (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)
Sequential organ failure assessment (SOFA)Up to 72 hours after hospitalizationSOFA scores will be available for patients admitted because of an infection.
Vital parametersUntil hospital discharge, up to 3 monthsHeart 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).
BiomarkersUp to 5 yearsLaboratory 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.

Countries

Netherlands

Contacts

Primary ContactHjalmar Bouma, MD, PhD
acutelines@umcg.nl+31 50 361 6161

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026