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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Medical Center Groningen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Referred for organ transplantation as recipient

Transfer from other hospital

Accidental contact patient material (i.e. internal work-related accident)

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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
2

Katz ADL-6 (functioning)

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

Time frame
Up to 1 year
3

World Health Organization (WHO) performance status (functioning)

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

Time frame
Up to 1 year
4

Karnofsky performance score (functioning)

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

Time frame
Up to 1 year

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.