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NCT Number: NCT04615065

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

Location status: Recruiting

Location contact

Ewoud ter Avest, MD, PhD

SUB_INVESTIGATOR

Hjalmar Bouma, MD, PhD

CONTACT

[email protected]

0503616161

Hjalmar Bouma, MD, PhD

PRINCIPAL_INVESTIGATOR

Jan ter Maaten, MD, PhD

SUB_INVESTIGATOR

About this study

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])

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Mortality (time and cause)

    Time frame: 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).

  2. Katz ADL-6 (functioning)

    Time frame: Up to 1 year

    Katz ADL-6 (0-6, fully dependent-independent)

  3. World Health Organization (WHO) performance status (functioning)

    Time frame: Up to 1 year

    World Health Organization (WHO) performance status (0-4, normal performance-bedridden)

  4. Karnofsky performance score (functioning)

    Time frame: Up to 1 year

    Karnofsky performance score (10-100, moribund-normal performance)

  5. Utrecht Activity List (daily activities)

    Time frame: 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 )

  6. Short QUestionnaire to ASsess Health-enhancing physical activity (daily activities)

    Time frame: 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)

  7. Quality of Life and experienced symptoms

    Time frame: 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)

  8. Experienced somatic symptoms

    Time frame: Up to 1 year

    Patient Health Questionnaire-15 (PHQ-15; 0-30, minimal-high somatic symptom severity)

  9. Fatigue

    Time frame: 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)

  10. Patient Health Questionnaire-2 (mental health)

    Time frame: Up to 1 year

    Patient Health Questionnaire-2 (PHQ-2; 0-6, higher score corresponds to reduced mental health)

  11. Patient Health Questionnaire-9 (mental health)

    Time frame: 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)

  12. Geriatric Depression scale-15 (mental health)

    Time frame: Up to 1 year

    Geriatric Depression scale-15 (GDS-15; 0-4 no depressive symptoms, 5-10 mild depressive symptoms, 11-15 depressive symptoms)

  13. Patient satisfaction

    Time frame: 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)

  14. Decision making

    Time frame: 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)

  15. Co-morbidity

    Time frame: 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)

  16. Length-of-stay in hospital/intensive care unit (ICU)

    Time frame: Until hospital discharge, an average of 2 weeks

    Length-of-stay in hospital and on intensive care unit (ICU) in days

Secondary outcomes

  1. Biomarkers

    Time frame: 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.

  2. Medication use

    Time frame: Up to 5 years

    Medication use will be retrieved from the electronic health records (EHR) from the hospital, general practitioner and pharmacy.

  3. Treatment (non-pharmacological, including organ support)

    Time frame: 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)

  4. Sequential organ failure assessment (SOFA)

    Time frame: Up to 72 hours after hospitalization

    SOFA scores will be available for patients admitted because of an infection.

  5. Vital parameters

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Hjalmar Bouma, MD, PhD

CONTACT

[email protected]

+31 50 361 6161

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study 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

Acronym: Acutelines

Important dates

Study start
2020
Primary completion
2030
Study completion
2030
First posted
Nov 4, 2020
Registry last updated
Jun 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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