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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

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])

Eligibility

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 details
    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

NCT04615065

University Medical Center Groningen

23 June 2024

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