Critically IllNCT02837419
Cost-effectiveness of Extracorporeal Life Support Treatment
An observational study of Critically Ill, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
This study evaluates patients on ECLS treatment as considered appropriate with mortality and health related Quality of life and costs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill
- What is being tested?
- Health related Quality of life EQ-5D
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Dec 2017to 1 Jan 2020
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Critically ill patients on the ICU treated with extracorporeal life support
Who may be able to join
- Admitted to intensive care
- Treated with extracorporeal life support
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Groningen
Groningen, 9700 RB
Wim Dieperink, PhD, +31503619838, w.dieperink@umcg.nl
Walter m van den Bergh, MD, PhD
About this study
Official title: A Multicenter Prospective Observational Cohort Study Determining the Cost-effectiveness of Extracorporal Life Support (ECLS) Treatment
This study evaluates patients on ECLS treatment as considered appropriate with mortality and health related Quality of life and costs.
Read the detailed description
A direct comparison between usual care and ECLS treatment is difficult. Alternatively we compare predicted mortality for every patient based on validated scoring systems at the initiation of ECLS treatment with the actual outcome, so every patient is his own control.
Primary outcome is HRQoL assessed with the EQ-5D questionnaire at 1 year. Healthcare costs and costs from a societal perspective are prospectively measured.
- Conditions
- Critically Ill
- Being tested
- Health related Quality of life EQ-5D
- Keywords
- extracorporeal life support, health related quality of life
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health related Quality of life EQ-5DBehavioural
Quality of Care
What is being measured
The primary outcome is the main question the study is designed to answer.
health related quality of life
health related quality of life with EQ-5D questionnaire at 6 and 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study start1 Dec 2017
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Critically IllStudies 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
- 200 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Willem Dieperink, University Medical Center Groningen
- Investigators
- walter m van den Bergh, MD, PhD, Principal investigator, department of critical care, UMCG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02837419
- Sponsor's protocol ID
- Dutch ECLS/2014/QoL
- Status last verified
- Sep 2019
- First submitted
- 15 Jul 2016
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Jolink FEJ, Onrust M, Dos Reis Miranda D, Mandigers L, Delnoij T, Maas JJ, Raasveld SJ, Vlaar APJ, Donker DW, Scholten E, de Metz J, van den Brule J, Kuijpers M, Vermeulen KM, van der Voort PHJ, van den Bergh WM, Oude Lansink-Hartgring A; Dutch Extracorporeal Life Support (ECLS) Study Group. Five Years After Extracorporeal Membrane Oxygenation: A Prospective Cohort Study of Health-Related Quality of Life and Patient Outcomes. Crit Care Med. 2025 Dec 1;53(12):e2487-e2496. doi: 10.1097/CCM.0000000000006900. Epub 2025 Oct 15.
PubMed 41091003Oude Lansink-Hartgring A, Dos Reis Miranda D, Donker DW, Maas JJ, Delnoij T, Kuijpers M, van den Brule J, Scholten E, Endeman H, Vlaar APJ, van den Bergh WM; Dutch ECLS study group. Cost-effectiveness in extracorporeal life support in critically ill adults in the Netherlands. BMC Health Serv Res. 2018 Mar 9;18(1):172. doi: 10.1186/s12913-018-2964-6.
PubMed 29523153
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Observational Cohort Study Determining the Cost-effectiveness of Extracorporal Life Support (ECLS) Treatment
- ClinicalTrials.gov ID
- NCT02837419
- Acronym / sponsor ID
- Dutch ECLS/2014/QoL
- Conditions
- Critically Ill
- Keywords
- extracorporeal life support, health related quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 19 Jul 2016 (estimated)
- 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.
This study evaluates patients on ECLS treatment as considered appropriate with mortality and health related Quality of life and costs.
Detailed description
A direct comparison between usual care and ECLS treatment is difficult. Alternatively we compare predicted mortality for every patient based on validated scoring systems at the initiation of ECLS treatment with the actual outcome, so every patient is his own control.
Primary outcome is HRQoL assessed with the EQ-5D questionnaire at 1 year. Healthcare costs and costs from a societal perspective are prospectively measured.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients on the ICU treated with extracorporeal life support
Key inclusion criteria (2 listed)
- Admitted to intensive care
- Treated with extracorporeal life support
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health related Quality of life EQ-5DQuality of Care | Behavioural | – |
Primary outcome
health related quality of life
Time frame: 12 months
health related quality of life with EQ-5D questionnaire at 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Derived from this study: PubMed 41091003Jolink FEJ, Onrust M, Dos Reis Miranda D, Mandigers L, Delnoij T, Maas JJ, Raasveld SJ, Vlaar APJ, Donker DW, Scholten E, de Metz J, van den Brule J, Kuijpers M, Vermeulen KM, van der Voort PHJ, van den Bergh WM, Oude Lansink-Hartgring A; Dutch Extracorporeal Life Support (ECLS) Study Group. Five Years After Extracorporeal Membrane Oxygenation: A Prospective Cohort Study of Health-Related Quality of Life and Patient Outcomes. Crit Care Med. 2025 Dec 1;53(12):e2487-e2496. doi: 10.1097/CCM.0000000000006900. Epub 2025 Oct 15.
- Derived from this study: PubMed 29523153Oude Lansink-Hartgring A, Dos Reis Miranda D, Donker DW, Maas JJ, Delnoij T, Kuijpers M, van den Brule J, Scholten E, Endeman H, Vlaar APJ, van den Bergh WM; Dutch ECLS study group. Cost-effectiveness in extracorporeal life support in critically ill adults in the Netherlands. BMC Health Serv Res. 2018 Mar 9;18(1):172. doi: 10.1186/s12913-018-2964-6.
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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. This study is not recruiting at the moment.
walter m van den Bergh, MD, PhD principal investigator
department of critical care, UMCG
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 Critically Ill, 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 25 Sep 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wim Dieperink, PhD (+31503619838 ext. 49838, w.dieperink@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
health related quality of life (time frame: 12 months). 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 NCT02837419, which also lists 2 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 25 Sep 2019.