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

June 12, 2024 updated by: University Medical Center Groningen

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9700 RB
        • Recruiting
        • University Medical Center Groningen
        • Contact:
        • Principal Investigator:
          • Hjalmar Bouma, MD, PhD
        • Sub-Investigator:
          • Ewoud ter Avest, MD, PhD
        • Sub-Investigator:
          • Jan ter Maaten, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Until the death of death from any cause, up to 50 years
Katz ADL-6 (functioning)
Time Frame: Up to 1 year
Katz ADL-6 (0-6, fully dependent-independent)
Up to 1 year
World Health Organization (WHO) performance status (functioning)
Time Frame: Up to 1 year
World Health Organization (WHO) performance status (0-4, normal performance-bedridden)
Up to 1 year
Karnofsky performance score (functioning)
Time Frame: Up to 1 year
Karnofsky performance score (10-100, moribund-normal performance)
Up to 1 year
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 )
Up to 1 year
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)
Up to 1 year
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)
Up to 1 year
Experienced somatic symptoms
Time Frame: Up to 1 year
Patient Health Questionnaire-15 (PHQ-15; 0-30, minimal-high somatic symptom severity)
Up to 1 year
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)
Up to 1 year
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)
Up to 1 year
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)
Up to 1 year
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)
Up to 1 year
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)
Up to 1 year
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)
Up to 1 year
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)
Up to 5 years
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
Until hospital discharge, an average of 2 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Up to 5 years
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.
Up to 5 years
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)
Until hospital discharge, up to 3 months
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.
Up to 72 hours after hospitalization
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).
Until hospital discharge, up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Medical Center Groningen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Jan ter Maaten, MD, PhD, University Medical Center Groningen
  • Study Chair: Ewoud ter Avest, MD, PhD, University Medical Center Groningen
  • Study Director: Hjalmar Bouma, MD, PhD, University Medical Center Groningen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 18, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 4, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 13, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 201900635

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data (IPD) may be available to other researchers if needed for their specific research purposes, which amongst others must be in line with the study protocol, the informed consent form and the general data protection regulations (GDPR). Each request for re-use of data will be reviewed by Acutelines' steering group, manager and local review board (LRb), prior to establishing a material and data transfer agreement (MDTA). No IPD will be shared if not required to answer research question.

IPD Sharing Time Frame

Supporting information will become available short after initiation of the study and will remain available until the end of the study (undetermined).

IPD Sharing Access Criteria

Supporting information will either be made available through the website (http://acutelines.umcg.nl), LinkedIn (https://www.linkedin.com/company/acutelines) and/or upon reasonable request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings