Respiratory Distress Syndrome, AdultPRE-VIKINCT03969914
PEEP-induced Changed in RRI as Physiological Background of Ventilator-induced Kidney Injury
An observational study of Respiratory Distress Syndrome, Adult and Respiration, Artificial, run by Università degli Studi di Ferrara at 2 sites in Italy.
Trial summary
The renal Doppler resistive index (RRI) is a noninvasive tool that has been used to assess renal perfusion in the intensive care unit (ICU) setting. Many parameters have been described as influential on the values of renal RI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Distress Syndrome, Adult, Respiration, Artificial, Acute Kidney Injury
- What is being tested?
- PEEP changes
- Type of treatment
- Surgery or procedure
- How many people
- 105 participants
- Where
- 2 sitesItaly
- Study dates
- 1 May 2019to 15 Jun 2020
- 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: Cohort of critically ill patients
Who may be able to join
- Patients admitted to ICU with expected mechanical ventilation >48h
Who cannot join
- Ultrasound RRI evaluation non available
- Patients with arrhythmia
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Università di Ferrara
Ferrara, 44121
Università di Siena
Siena, 53100
About this study
The renal Doppler resistive index (RRI) is a noninvasive tool that has been used to assess renal perfusion in the intensive care unit (ICU) setting. Many parameters have been described as influential on the values of renal RI. Mechanical ventilation is associated with significant increases in the risk of acute kidney injury (AKI). Ventilator-induced kidney injury (VIKI) is believed to occur due to changes in hemodynamics that impair renal perfusion. The investigators hypothesized that patients who need mechanical ventilation should have a different response in RRI when different levels of Positive end expiratory pressure (PEEP) are applied. Investigators wish to describe changing in RRI due to changes in PEEP and to verify whether these changes could partially explain the occurrence of VIKI
- Being tested
- PEEP changes
- Medical subject headings
- Respiratory Distress Syndrome, Respiratory Aspiration, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEP changesProcedure or surgery
All patients will be ventilated with a tidal volume of 6 ml/kg before the RRI assessment. Further, three level of PEEP (5, 10 and 15 cmH2O) will be randomly set. For each levels of PEEP, the RRI will be evaluated
| Study group | Role | What they receive |
|---|---|---|
| Critically ill ventilated patients | Patients admitted to ICU with expected mechanical ventilation >48h Receives: Procedure: PEEP changes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of AKI
AKI will be defined according to Kidney Disease: Improving Global Outcomes (KDIGO) criteria
Measured: once a day until day 7
Secondary outcomes (1)
Change in RRI at different level of PEEP
To compare median difference of RRI at PEEP 5 and PEEP 15 in patients who will develop (or not) AKI
Measured: One a day until day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start1 May 2019
- Primary completion1 May 2020
- Study completion15 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress Syndrome, AdultStudies of the same condition, open and under way.
- 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
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alberto Fogagnolo, Università degli Studi di Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03969914
- Sponsor's protocol ID
- RRIPEEP
- Acronym
- PRE-VIKI
- Status last verified
- Apr 2022
- First submitted
- 28 May 2019
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared under reasonable request to the principal investigator
Publications
Fogagnolo A, Grasso S, Morelli E, Murgolo F, Di Mussi R, Vetrugno L, La Rosa R, Volta CA, Spadaro S. Impact of positive end-expiratory pressure on renal resistive index in mechanical ventilated patients. J Clin Monit Comput. 2024 Oct;38(5):1145-1153. doi: 10.1007/s10877-024-01172-z. Epub 2024 May 21.
PubMed 38771490
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PEEP-induced Changed in RRI as Physiological Background of Ventilator-induced Kidney Injury
- ClinicalTrials.gov ID
- NCT03969914
- Acronym / sponsor ID
- PRE-VIKI / RRIPEEP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Università degli Studi di FerraraUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 15 Jun 2020 (actual)
- First posted
- 31 May 2019 (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.
The renal Doppler resistive index (RRI) is a noninvasive tool that has been used to assess renal perfusion in the intensive care unit (ICU) setting. Many parameters have been described as influential on the values of renal RI. Mechanical ventilation is associated with significant increases in the risk of acute kidney injury (AKI). Ventilator-induced kidney injury (VIKI) is believed to occur due to changes in hemodynamics that impair renal perfusion. The investigators hypothesized that patients who need mechanical ventilation should have a different response in RRI when different levels of Positive end expiratory pressure (PEEP) are applied. Investigators wish to describe changing in RRI due to changes in PEEP and to verify whether these changes could partially explain the occurrence of VIKI
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically ill ventilated patients | – | Procedure: PEEP changesPatients admitted to ICU with expected mechanical ventilation >48h |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cohort of critically ill patients
Key inclusion criteria (1 listed)
- Patients admitted to ICU with expected mechanical ventilation >48h
Key exclusion criteria (3 listed)
- Ultrasound RRI evaluation non available
- Patients with arrhythmia
- Pregnancy
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 |
|---|---|---|
| PEEP changesAll patients will be ventilated with a tidal volume of 6 ml/kg before the RRI assessment. Further, three level of PEEP (5, 10 and 15 cmH2O) will be randomly set. For each levels of PEEP, the RRI will be evaluated | Procedure or surgery | Critically ill ventilated patients |
Primary outcome
Occurence of AKI
Time frame: once a day until day 7
AKI will be defined according to Kidney Disease: Improving Global Outcomes (KDIGO) criteria
1 secondary outcome
Change in RRI at different level of PEEP
Time frame: One a day until day 5
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 28 Apr 2022.
- Derived from this study: PubMed 38771490Fogagnolo A, Grasso S, Morelli E, Murgolo F, Di Mussi R, Vetrugno L, La Rosa R, Volta CA, Spadaro S. Impact of positive end-expiratory pressure on renal resistive index in mechanical ventilated patients. J Clin Monit Comput. 2024 Oct;38(5):1145-1153. doi: 10.1007/s10877-024-01172-z. Epub 2024 May 21.
- Individual participant dataSharing planned: Yes. IPD will be shared under reasonable request to the principal investigator
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Distress Syndrome, Adult and Respiration, Artificial, run by Università degli Studi di Ferrara at 2 sites in Italy.
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 1 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 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
Occurence of AKI (time frame: once a day until day 7). 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 NCT03969914, which also lists 1 linked publication.
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 28 Apr 2022.