Acute DiseaseAcutelinesNCT04615065
Acutelines: a Large Data-/Biobank of Acute and Emergency Medicine
An observational study of Acute Disease and Sepsis, run by University Medical Center Groningen at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Disease, Sepsis, Pneumonia
- How many people
- 35,000 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Sep 2020to 1 Sep 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 13Show fewer
- Syncope
- Intoxication
- Thrombosis
- Pulmonary embolism
- Bleeding while using anti-coagulant drugs
- Gastro-intestinal bleeding
- Electrolyte disturbance
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Groningen
Groningen, 9700 RB
Hjalmar Bouma, MD, PhD, 0503616161, acutelines@umcg.nl
Hjalmar Bouma, MD, PhD
About this study
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
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.
Read the 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])
- Conditions
- Acute Disease, Sepsis, Pneumonia, Frailty, Complication of Treatment, Pulmonary Embolism
- Keywords
- Acute disease, Sepsis, Emergency Medical Service (EMS), Outcome, Precision medicine, Personalized medicine, Emergency medicine, Multidisciplinary, General practitionar, Pharmacy, Hospitalization, Health insurance, Mortality, Quality of life (QoL), Overcrowding, Patient logistics, Point-of-care ultrasound (POCUS), Helicopter Emergency Medical Service (HEMS), Biobank, Databank
- Medical subject headings
- Acute Disease, Sepsis, Pneumonia, Frailty, Pulmonary Embolism, Thrombosis, Acute Kidney Injury, Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Until the death of death from any cause, up to 50 years
Katz ADL-6 (functioning)
Katz ADL-6 (0-6, fully dependent-independent)
Measured: Up to 1 year
World Health Organization (WHO) performance status (functioning)
World Health Organization (WHO) performance status (0-4, normal performance-bedridden)
Measured: Up to 1 year
Karnofsky performance score (functioning)
Karnofsky performance score (10-100, moribund-normal performance)
Measured: Up to 1 year
Utrecht Activity List (daily activities)
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 )
Measured: Up to 1 year
Short QUestionnaire to ASsess Health-enhancing physical activity (daily activities)
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)
Measured: Up to 1 year
Quality of Life and experienced symptoms
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)
Measured: Up to 1 year
Experienced somatic symptoms
Patient Health Questionnaire-15 (PHQ-15; 0-30, minimal-high somatic symptom severity)
Measured: Up to 1 year
Fatigue
Piper Fatigue Scale-12 (PFS-12; 0-10, higher scores reflect more fatigue among four subscales (a) behavior, (b) affect, (c) sensory, (d) cognition)
Measured: Up to 1 year
Patient Health Questionnaire-2 (mental health)
Patient Health Questionnaire-2 (PHQ-2; 0-6, higher score corresponds to reduced mental health)
Measured: Up to 1 year
Patient Health Questionnaire-9 (mental health)
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)
Measured: Up to 1 year
Geriatric Depression scale-15 (mental health)
Geriatric Depression scale-15 (GDS-15; 0-4 no depressive symptoms, 5-10 mild depressive symptoms, 11-15 depressive symptoms)
Measured: Up to 1 year
Patient satisfaction
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)
Measured: Up to 1 year
Decision making
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)
Measured: Up to 1 year
Co-morbidity
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)
Measured: Up to 5 years
Length-of-stay in hospital/intensive care unit (ICU)
Length-of-stay in hospital and on intensive care unit (ICU) in days
Measured: Until hospital discharge, an average of 2 weeks
Secondary outcomes (5)
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.
Measured: Up to 5 years
Medication use
Medication use will be retrieved from the electronic health records (EHR) from the hospital, general practitioner and pharmacy.
Measured: Up to 5 years
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)
Measured: Until hospital discharge, up to 3 months
Sequential organ failure assessment (SOFA)
SOFA scores will be available for patients admitted because of an infection.
Measured: Up to 72 hours after hospitalization
Vital parameters
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).
Measured: Until hospital discharge, up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start1 Sep 2020
- Primary completion1 Sep 2030 (estimated)
- Study completion1 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute DiseaseStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ewoud ter Avest, MD, PhD, Study chair, University Medical Center GroningenJan ter Maaten, MD, PhD, Study director, University Medical Center GroningenHjalmar Bouma, MD, PhD, Study director, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04615065
- Sponsor's protocol ID
- 201900635
- Acronym
- Acutelines
- Status last verified
- Jun 2024
- First submitted
- 18 Oct 2020
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
van der Aart TJ, Luxen M, Koeze J, Londen MV, Hackl M, Ter Maaten JC, van Meurs M, Bouma HR; the Acutelines research group. Validation of plasma microRNAs as biomarkers in sepsis associated acute kidney injury upon first clinical presentation reveals limited diagnostic and prognostic performance. PLoS One. 2025 Sep 4;20(9):e0331442. doi: 10.1371/journal.pone.0331442. eCollection 2025.
PubMed 40906653van der Aart TJ, Visser M, van Londen M, van de Wetering KMH, Ter Maaten JC, Bouma HR; Acutelines research group. The smell of sepsis: Electronic nose measurements improve early recognition of sepsis in the ED. Am J Emerg Med. 2025 Feb;88:126-133. doi: 10.1016/j.ajem.2024.11.045. Epub 2024 Nov 26.
PubMed 39615435Ter Avest E, van Munster BC, van Wijk RJ, Tent S, Ter Horst S, Hu TT, van Heijst LE, van der Veer FS, van Beuningen FE, Ter Maaten JC, Bouma HR. Cohort profile of Acutelines: a large data/biobank of acute and emergency medicine. BMJ Open. 2021 Jul 15;11(7):e047349. doi: 10.1136/bmjopen-2020-047349.
PubMed 34266842
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04615065
- Acronym / sponsor ID
- Acutelines / 201900635
- Conditions
- Acute Disease, Sepsis, Pneumonia, Frailty, Complication of Treatment, Pulmonary Embolism
- Keywords
- Acute disease, Sepsis, Emergency Medical Service (EMS), Outcome, Precision medicine, Personalized medicine, Emergency medicine, Multidisciplinary
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 35,000 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Sep 2030 (estimated)
- Study completion
- 1 Sep 2030 (estimated)
- First posted
- 4 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (13 listed)
- 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)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Katz ADL-6 (functioning)
Time frame: Up to 1 year
Katz ADL-6 (0-6, fully dependent-independent)
World Health Organization (WHO) performance status (functioning)
Time frame: Up to 1 year
World Health Organization (WHO) performance status (0-4, normal performance-bedridden)
Karnofsky performance score (functioning)
Time frame: Up to 1 year
Karnofsky performance score (10-100, moribund-normal performance)
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 )
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)
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)
Experienced somatic symptoms
Time frame: Up to 1 year
Patient Health Questionnaire-15 (PHQ-15; 0-30, minimal-high somatic symptom severity)
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)
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)
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)
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)
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)
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)
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)
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
5 secondary outcomes
Biomarkers
Time frame: Up to 5 years
Medication use
Time frame: Up to 5 years
Treatment (non-pharmacological, including organ support)
Time frame: Until hospital discharge, up to 3 months
Sequential organ failure assessment (SOFA)
Time frame: Up to 72 hours after hospitalization
Vital parameters
Time frame: Until hospital discharge, up to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Derived from this study: PubMed 40906653van der Aart TJ, Luxen M, Koeze J, Londen MV, Hackl M, Ter Maaten JC, van Meurs M, Bouma HR; the Acutelines research group. Validation of plasma microRNAs as biomarkers in sepsis associated acute kidney injury upon first clinical presentation reveals limited diagnostic and prognostic performance. PLoS One. 2025 Sep 4;20(9):e0331442. doi: 10.1371/journal.pone.0331442. eCollection 2025.
- Derived from this study: PubMed 39615435van der Aart TJ, Visser M, van Londen M, van de Wetering KMH, Ter Maaten JC, Bouma HR; Acutelines research group. The smell of sepsis: Electronic nose measurements improve early recognition of sepsis in the ED. Am J Emerg Med. 2025 Feb;88:126-133. doi: 10.1016/j.ajem.2024.11.045. Epub 2024 Nov 26.
- Derived from this study: PubMed 34266842Ter Avest E, van Munster BC, van Wijk RJ, Tent S, Ter Horst S, Hu TT, van Heijst LE, van der Veer FS, van Beuningen FE, Ter Maaten JC, Bouma HR. Cohort profile of Acutelines: a large data/biobank of acute and emergency medicine. BMJ Open. 2021 Jul 15;11(7):e047349. doi: 10.1136/bmjopen-2020-047349.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ewoud ter Avest, MD, PhD study chair
University Medical Center Groningen
Jan ter Maaten, MD, PhD study director
University Medical Center Groningen
Hjalmar Bouma, MD, PhD study director
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Disease and Sepsis, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hjalmar Bouma, MD, PhD (+31 50 361 6161, acutelines@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time and cause) (time frame: Until the death of death from any cause, up to 50 years). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04615065, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.