An observational study in Acute Disease, Sepsis and Pneumonia, sponsored by University Medical Center Groningen. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-13.
Sponsored by University Medical Center Groningen · Observational
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.
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:
57 studies on the registry are indexed under Acute Disease; 12 are open to participants now.
This study's planned enrollment of 35,000 is above the median of 900 across 22 observational studies indexed under Acute Disease.
Browse Acute Disease studies →University Medical Center Groningen is the lead sponsor of 627 studies on the registry; 176 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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).
Time frame: Until the death of death from any cause, up to 50 years
Katz ADL-6 (functioning)
Katz ADL-6 (0-6, fully dependent-independent)
Time frame: Up to 1 year
World Health Organization (WHO) performance status (functioning)
World Health Organization (WHO) performance status (0-4, normal performance-bedridden)
Time frame: Up to 1 year
Karnofsky performance score (functioning)
Karnofsky performance score (10-100, moribund-normal performance)
Time frame: 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 )
Time frame: 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)
Time frame: 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)
Time frame: Up to 1 year
Experienced somatic symptoms
Patient Health Questionnaire-15 (PHQ-15; 0-30, minimal-high somatic symptom severity)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: Until hospital discharge, an average of 2 weeks
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.
Time frame: Up to 5 years
Medication use
Medication use will be retrieved from the electronic health records (EHR) from the hospital, general practitioner and pharmacy.
Time frame: 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)
Time frame: Until hospital discharge, up to 3 months
Sequential organ failure assessment (SOFA)
SOFA scores will be available for patients admitted because of an infection.
Time frame: 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).
Time frame: Until hospital discharge, up to 3 months
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
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.
Data sharing details ↗ · acutelines.umcg.nl
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