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

Recruiting

• Conditions: Pneumonia; Pulmonary Embolism; Electrolyte Disturbance; Emergencies; Syncope; Acute Disease; Anaphylaxis; Frailty; Complication of Treatment; Thrombosis

• Registration Number: NCT04615065
• Lead Sponsor: University Medical Center Groningen

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 \[ICU\])

Study Timeline

• Study Start: 2020-09-01
• Study First Submitted: 2020-10-18
• Study First Submitted QC: 2020-11-03
• Study First Posted: 2020-11-04
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-12
• Last Update Posted: 2024-06-13
• Primary Completion: 2030-09-01
• Study Completion: 2030-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 35000

Inclusion Criteria

Not provided

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Experienced somatic symptoms	Up to 1 year	Patient Health Questionnaire-15 (PHQ-15; 0-30, minimal-high somatic symptom severity)
Mortality (time and cause)	Until the death of death from any cause, up to 50 years	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).
Utrecht Activity List (daily activities)	Up to 1 year	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 )
Short QUestionnaire to ASsess Health-enhancing physical activity (daily activities)	Up to 1 year	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)
Patient satisfaction	Up to 1 year	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)
Katz ADL-6 (functioning)	Up to 1 year	Katz ADL-6 (0-6, fully dependent-independent)
Karnofsky performance score (functioning)	Up to 1 year	Karnofsky performance score (10-100, moribund-normal performance)
Fatigue	Up to 1 year	Piper Fatigue Scale-12 (PFS-12; 0-10, higher scores reflect more fatigue among four subscales (a) behavior, (b) affect, (c) sensory, (d) cognition)
World Health Organization (WHO) performance status (functioning)	Up to 1 year	World Health Organization (WHO) performance status (0-4, normal performance-bedridden)
Quality of Life and experienced symptoms	Up to 1 year	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)
Decision making	Up to 1 year	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)
Patient Health Questionnaire-2 (mental health)	Up to 1 year	Patient Health Questionnaire-2 (PHQ-2; 0-6, higher score corresponds to reduced mental health)
Patient Health Questionnaire-9 (mental health)	Up to 1 year	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)
Geriatric Depression scale-15 (mental health)	Up to 1 year	Geriatric Depression scale-15 (GDS-15; 0-4 no depressive symptoms, 5-10 mild depressive symptoms, 11-15 depressive symptoms)
Length-of-stay in hospital/intensive care unit (ICU)	Until hospital discharge, an average of 2 weeks	Length-of-stay in hospital and on intensive care unit (ICU) in days
Co-morbidity	Up to 5 years	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)

Secondary Outcome Measures

Name	Time	Method
Sequential organ failure assessment (SOFA)	Up to 72 hours after hospitalization	SOFA scores will be available for patients admitted because of an infection.
Medication use	Up to 5 years	Medication use will be retrieved from the electronic health records (EHR) from the hospital, general practitioner and pharmacy.
Vital parameters	Until hospital discharge, up to 3 months	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).
Biomarkers	Up to 5 years	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.
Treatment (non-pharmacological, including organ support)	Until hospital discharge, up to 3 months	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)

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands