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

Sponsor

Hjalmar Bouma (Other)

Overall Status

Recruiting

CT.gov ID

NCT04615065

Collaborator

(none)

35,000

Enrollment

Location

120

Anticipated Duration (Months)

291.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

35000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 1, 2020

Anticipated Primary Completion Date :

Sep 1, 2030

Anticipated Study Completion Date :

Sep 1, 2030

Outcome Measures

Primary Outcome Measures

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).
Katz ADL-6 (functioning) [Up to 1 year]
Katz ADL-6 (0-6, fully dependent-independent)
World Health Organization (WHO) performance status (functioning) [Up to 1 year]
World Health Organization (WHO) performance status (0-4, normal performance-bedridden)
Karnofsky performance score (functioning) [Up to 1 year]
Karnofsky performance score (10-100, moribund-normal performance)
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)
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)
Experienced somatic symptoms [Up to 1 year]
Patient Health Questionnaire-15 (PHQ-15; 0-30, minimal-high somatic symptom severity)
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)
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)
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)
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)
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)
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

Secondary Outcome Measures

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.
Medication use [Up to 5 years]
Medication 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 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)
Sequential organ failure assessment (SOFA) [Up to 72 hours after hospitalization]
SOFA scores will be available for patients admitted because of an infection.
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Medical Center Groningen	Groningen		Netherlands	9700 RB

Sponsors and Collaborators

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