ARDS (Acute Respiratory Distress Syndrome)VENTURINCT07368868
Effect of Initiation of Veno-venous ECMO on Urine Output and Acute Kidney Injury
An observational study of ARDS (Acute Respiratory Distress Syndrome) and Acute Kidney Injury, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
With this study, the investigators want to find out whether the use of a "lung machine" (extracorporeal membrane oxygenation (ECMO)) togethet with giving the lungs "rest" (by minimizing ventilary support) in people with severe pneumonia has an effect on how well the kidneys work. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS (Acute Respiratory Distress Syndrome), Acute Kidney Injury, ECMO
- How many people
- 76 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Dec 2025to 1 Dec 2025
- 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: Adult patients admitted on the ICU of Ghent Univesity Hospital with acute respiratory distress who received support by veno-venous ECMO between 1 January 2019 and 31 December 2023
Who may be able to join
- Age 18 years or older
- Admission to the Intensive Care Unit (ICU) of Ghent University Hospital
- Treatment with veno-venous extracorporeal membrane oxygenation (VV- ECMO)
- ICU admission between 1 January 2019 and 31 December 2023
Who cannot join
- Receipt of renal replacement therapy (RRT) prior to ICU admission
- Patients already receiving VV-ECMO at the time of admission to the ICU of Ghent University Hospital (i.e., patients referred from another hospital on VV-ECMO)
- Patients who received VV-ECMO immediately upon admission to the ICU of Ghent University Hospital
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Ultraprotective Ventilation After Veno-venous ECMO Initiation on Urine Output and Acute Kidney Injury (VENTURI) - a Retrospective Single Center Study
With this study, the investigators want to find out whether the use of a "lung machine" (extracorporeal membrane oxygenation (ECMO)) togethet with giving the lungs "rest" (by minimizing ventilary support) in people with severe pneumonia has an effect on how well the kidneys work.
The investigators will use information that was already collected while patients were staying in the intensive care unit. Patients do not need to do anything additional or undergo any additional procedures for this study.
Read the detailed description
Some people with severe pneumonia need to be admitted to the intensive care unit. In very serious cases, the lungs may work so poorly that breathing without help is no longer possible. These patients then receive support from a breathing machine (a ventilator). Sometimes even this support is not enough, and a special machine is needed to temporarily take over the function of the lungs. This machine is called a "lung machine" (also known as ECMO).
When a patient is connected to this lung machine, the patient's own lungs are exposed to as little pressure and stimulation as possible. This is called "lung rest" and gives the lungs time to heal.
In people who are very ill, such as those with severe pneumonia, other organs can also be affected. The kidneys, which are important for making urine and removing waste products from the body, may suddenly stop working as well as they should. This study will examine whether using the lung machine and lung rest affects how the kidneys work.
- Keywords
- ECMO, acute kidney injury, ARDS
- Medical subject headings
- Acute Lung Injury, Acute Kidney Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in urine output (staged by KDIGO criteria) 6h before and after start veno-venous ECMO and ultraprotective ventilation
The difference in urine output will be investigated before and after start of veno-venous ECMO together with the initiation of ultraprotective ventilation. To compare the difference in urine output a timeframe of 6 hours before ECMO wil be compared to a timeframe six hours after ECMO initiation. The 6 hour timeframe was choosen because this is the duration of the AKI KDIGO stage 1 urine output criterium.
Measured: 6 hours
Secondary outcomes (3)
Difference in urine output (staged by KDIGO criteria) 12h before and after start veno-venous ECMO and ultraprotective ventilation.
The difference in urine output will be investigated before and after start of veno-venous ECMO together with the initiation of ultraprotective ventilation. To compare the difference in urine output a timeframe of 12 hours before ECMO will be compared to a 12 hour timeframe after ECMO initiation. The 12 hour timeframe was choosen because this is the duration of the AKI KDIGO stage 2 urine output criterium.
Measured: 12 hours
Difference in urine output (staged by KDIGO criteria) 24h before and after start veno-venous ECMO and ultraprotective ventilation.
The difference in urine output will be investigated before and after start of veno-venous ECMO together with the initiation of ultraprotective ventilation. To compare the difference in urine output a timeframe of 24 hours before ECMO will be compared to a 24 hour timeframe after ECMO initiation. The 24 hour timeframe was choosen because this is the duration of the AKI KDIGO stage 3 urine output criterium.
Measured: 24 hours
Difference in serum creatinine (staged by KDIGO criteria) 24h before and after start veno-venous ECMO and ultraprotective ventilation.
The difference in serum creatinine will be investigated before and after start of veno-venous ECMO together with the initiation of ultraprotective ventilation. To compare the difference in serum creatinine a timeframe of 24 hours before ECMO will be compared to a 24 hour timeframe after ECMO initiation. Acute kidney injuri and it severity will be defined by the KDIGO definition and classification.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start1 Dec 2025
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS (Acute Respiratory Distress Syndrome)Studies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- Retrospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07368868
- Sponsor's protocol ID
- ONZ-2025-0269
- Acronym
- VENTURI
- Status last verified
- Jan 2026
- First submitted
- 20 Jan 2026
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data of individuals will not be shared according to General Data Protection Regulation (GDPR)
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ultraprotective Ventilation After Veno-venous ECMO Initiation on Urine Output and Acute Kidney Injury (VENTURI) - a Retrospective Single Center Study
- ClinicalTrials.gov ID
- NCT07368868
- Acronym / sponsor ID
- VENTURI / ONZ-2025-0269
- Keywords
- ECMO, acute kidney injury, ARDS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 27 Jan 2026 (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.
With this study, the investigators want to find out whether the use of a "lung machine" (extracorporeal membrane oxygenation (ECMO)) togethet with giving the lungs "rest" (by minimizing ventilary support) in people with severe pneumonia has an effect on how well the kidneys work.
The investigators will use information that was already collected while patients were staying in the intensive care unit. Patients do not need to do anything additional or undergo any additional procedures for this study.
Detailed description
Some people with severe pneumonia need to be admitted to the intensive care unit. In very serious cases, the lungs may work so poorly that breathing without help is no longer possible. These patients then receive support from a breathing machine (a ventilator). Sometimes even this support is not enough, and a special machine is needed to temporarily take over the function of the lungs. This machine is called a "lung machine" (also known as ECMO).
When a patient is connected to this lung machine, the patient's own lungs are exposed to as little pressure and stimulation as possible. This is called "lung rest" and gives the lungs time to heal.
In people who are very ill, such as those with severe pneumonia, other organs can also be affected. The kidneys, which are important for making urine and removing waste products from the body, may suddenly stop working as well as they should. This study will examine whether using the lung machine and lung rest affects how the kidneys work.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted on the ICU of Ghent Univesity Hospital with acute respiratory distress who received support by veno-venous ECMO between 1 January 2019 and 31 December 2023
Key inclusion criteria (4 listed)
- Age 18 years or older
- Admission to the Intensive Care Unit (ICU) of Ghent University Hospital
- Treatment with veno-venous extracorporeal membrane oxygenation (VV- ECMO)
- ICU admission between 1 January 2019 and 31 December 2023
Key exclusion criteria (3 listed)
- Receipt of renal replacement therapy (RRT) prior to ICU admission
- Patients already receiving VV-ECMO at the time of admission to the ICU of Ghent University Hospital (i.e., patients referred from another hospital on VV-ECMO)
- Patients who received VV-ECMO immediately upon admission to the ICU of Ghent University Hospital
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
Difference in urine output (staged by KDIGO criteria) 6h before and after start veno-venous ECMO and ultraprotective ventilation
Time frame: 6 hours
The difference in urine output will be investigated before and after start of veno-venous ECMO together with the initiation of ultraprotective ventilation. To compare the difference in urine output a timeframe of 6 hours before ECMO wil be compared to a timeframe six hours after ECMO initiation. The 6 hour timeframe was choosen because this is the duration of the AKI KDIGO stage 1 urine output criterium.
3 secondary outcomes
Difference in urine output (staged by KDIGO criteria) 12h before and after start veno-venous ECMO and ultraprotective ventilation.
Time frame: 12 hours
Difference in urine output (staged by KDIGO criteria) 24h before and after start veno-venous ECMO and ultraprotective ventilation.
Time frame: 24 hours
Difference in serum creatinine (staged by KDIGO criteria) 24h before and after start veno-venous ECMO and ultraprotective ventilation.
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Individual participant dataSharing planned: No. Data of individuals will not be shared according to General Data Protection Regulation (GDPR)
Related trials for ARDS (Acute Respiratory Distress Syndrome)
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruitingObservational study
Development and Multicenter Validation of an Explainable System for Neonatal ARDS-Compatible Phenotyping
Acute Respiratory Distress Syndrome
RecruitingObservational study
Assessment of Blood Viscosity in ARDS (Acute Respiratory Distress Syndrome)
ARDS
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Recruiting
REspiratory MEchanics for Delivering Individualised Exogenous Surfactant
Respiratory Distress Syndrome in Premature Infant
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.
The record lists no contact. Use the official record to reach the sponsor.
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 ARDS (Acute Respiratory Distress Syndrome) and Acute Kidney Injury, run by University Hospital, Ghent at 1 site in Belgium.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 30 Jan 2026. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in urine output (staged by KDIGO criteria) 6h before and after start veno-venous ECMO and ultraprotective ventilation (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jan 2026.