Perfusion; ComplicationsKIDNEY-LUNGNCT03747731
A Non-invasive Evaluation of Kidney-Lung Interactions
An observational study of Perfusion; Complications and Mechanical Ventilation Complication, run by St. Bortolo Hospital at 1 site in Italy.
Trial summary
The present study aims to evaluate, with non-invasive methods, the relationships existing between PEEP and renal perfusion in patients undergoing surgery and requiring ventilatory support and monitoring in intensive care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perfusion; Complications, Mechanical Ventilation Complication
- How many people
- 109 participants
- Where
- 1 siteItaly
- Study dates
- 19 Nov 2018to 19 Nov 2019
- 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: Patients undergoing surgery and with the need for ventilatory support for the intensive care unit
Who may be able to join
- 18 Years and older
- Receiving mechanical ventilation, invasive blood pressure monitoring and an urinary catheter to monitor diuresis
- Need for postoperative monitoring in intensive care
- Written informed consent;
Who cannot join
- Acute kidney injury defined according to KDIGO guidelines;
- Pre-existing chronic renal disease;
- Heart failure;
- ARDS;
- Sepsis and Septic Shock;
- Hemodynamic instability with the need for vasoactive support;
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- Chronic or occasional therapy with drugs that could modify the renal blood flow and that can not be suspended two days before the study (Vasoactive agents, Ace-inhibitors, Beta-blockers, NSAIDs, Sartans and Diuretics therapy);
- Presumed or established state of pregnancy;
- Refusal of informed consent;
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
San Bortolo Hospital
Vicenza, 36100
Silvia De Rosa, MD, derosa.silvia@ymail.com
About this study
Official title: KIDNEY - LUNG INTERACTION: the Effect of End-expiratory Pressure on Renal Perfusion. Non-invasive Evaluation.
The present study aims to evaluate, with non-invasive methods, the relationships existing between PEEP and renal perfusion in patients undergoing surgery and requiring ventilatory support and monitoring in intensive care. Renal perfusion will be assessed at baseline (PEEP 0), subsequently ,at the application of progressive increases of PEEP. At the end of the measurements, the implications of the use of PEEP on the renal vascular system will be analyzed.
Read the detailed description
The present physiological, monocentric, observational clinical study evaluates the effect of progressive PEEP increases on renal perfusion in mechanically ventilated patients who underwent surgery with the need of ventilatory support and monitoring in intensive care.
Precisely, will be evaluated:
- The morphometric parameters (coronal diameter and cortico-medullary thickness) and the renal resistive indices (IR). The inter-lobar arteries will be sampled and the IRs will be measured as the upper and lower level and the mesorenes. Measurements will be performed both in the kidney and in baseline conditions and incremental values of PEEP (0 - 6 - 12).
- Gas exchanges, FC, systolic BP, diastolic and mean, Pmax, P1 and P2 of the airways, total and ohmic resistances and static respiratory compliance indexed for weight body (RRSmaxI, RRSminI, CrsI will be recorded).
The intra-class correlation coefficient will be measured to estimate the intra-observer reproducibility of the conducted measurement.
- Keywords
- Renal blood perfusion, Mechanical ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Resistive Index and Peep Titration | Enrolled patients will receive a sequential, step-wise increase in PEEP from 0 cmH2O to 12 cmH2O. The inter-lobar arterioles will be sampled at each PEEP increment and the IR will be measured as the average of three values recorded at the upper and lower pole and at the mesorenes in each kidney. Gas exchanges, HR, systolic, diastolic and mean PA, Pmax, P1 and P2 airway, total resistance and ohmic resistance and static respiratory compliance indexed for body weight (RRSmaxI, RRSminI, CrsI) will be measured at each Peep Level. The physiologic measurements will be obtained at regular intervals (within 15 minutes at each PEEP level) throughout the PEEP titration period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between IR and PEEP
Resistive index will be measured in both kidney and recorded using multifrequency convex probe.The association between positive end expiratory pressure and resistive index will be analyzed as the primary outcome.
Measured: Change from baseline to 60 minutes
Secondary outcomes (1)
Association between PEEP and Hemodynamics Paramenters
Resistive index will be measured in both kidney and recorded using multifrequency convex. FC, systolic, diastolic and mean PA will be measured at each PEEP level
Measured: Change from baseline to 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start19 Nov 2018
- Primary completion19 May 2019 (estimated)
- Study completion19 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perfusion; ComplicationsStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 109 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Bortolo Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvia De Rosa, St. Bortolo Hospital
- Investigators
- Silvia De Rosa, MD, Principal investigator, Ospedale San Bortolo di Vicenza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03747731
- Sponsor's protocol ID
- 88/18
- Acronym
- KIDNEY-LUNG
- Status last verified
- Nov 2018
- First submitted
- 18 Nov 2018
- Last updated
- 1 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KIDNEY - LUNG INTERACTION: the Effect of End-expiratory Pressure on Renal Perfusion. Non-invasive Evaluation.
- ClinicalTrials.gov ID
- NCT03747731
- Acronym / sponsor ID
- KIDNEY-LUNG / 88/18
- Keywords
- Renal blood perfusion, Mechanical ventilation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 109 participants (estimated)
- Lead sponsor
- St. Bortolo HospitalUniversity, hospital or other
- Study start
- 19 Nov 2018 (actual)
- Primary completion
- 19 May 2019 (estimated)
- Study completion
- 19 Nov 2019 (estimated)
- First posted
- 20 Nov 2018 (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 present study aims to evaluate, with non-invasive methods, the relationships existing between PEEP and renal perfusion in patients undergoing surgery and requiring ventilatory support and monitoring in intensive care. Renal perfusion will be assessed at baseline (PEEP 0), subsequently ,at the application of progressive increases of PEEP. At the end of the measurements, the implications of the use of PEEP on the renal vascular system will be analyzed.
Detailed description
The present physiological, monocentric, observational clinical study evaluates the effect of progressive PEEP increases on renal perfusion in mechanically ventilated patients who underwent surgery with the need of ventilatory support and monitoring in intensive care.
Precisely, will be evaluated:
- The morphometric parameters (coronal diameter and cortico-medullary thickness) and the renal resistive indices (IR). The inter-lobar arteries will be sampled and the IRs will be measured as the upper and lower level and the mesorenes. Measurements will be performed both in the kidney and in baseline conditions and incremental values of PEEP (0 - 6 - 12).
- Gas exchanges, FC, systolic BP, diastolic and mean, Pmax, P1 and P2 of the airways, total and ohmic resistances and static respiratory compliance indexed for weight body (RRSmaxI, RRSminI, CrsI will be recorded).
The intra-class correlation coefficient will be measured to estimate the intra-observer reproducibility of the conducted measurement.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Resistive Index and Peep Titration | – | –Enrolled patients will receive a sequential, step-wise increase in PEEP from 0 cmH2O to 12 cmH2O. The inter-lobar arterioles will be sampled at each PEEP increment and the IR will be measured as the average of three values recorded at the upper and lower pole and at the mesorenes in each kidney. Gas exchanges, HR, systolic, diastolic and mean PA, Pmax, P1 and P2 airway, total resistance and ohmic resistance and static respiratory compliance indexed for body weight (RRSmaxI, RRSminI, CrsI) will be measured at each Peep Level. The physiologic measurements will be obtained at regular intervals (within 15 minutes at each PEEP level) throughout the PEEP titration period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing surgery and with the need for ventilatory support for the intensive care unit
Key inclusion criteria (4 listed)
- 18 Years and older
- Receiving mechanical ventilation, invasive blood pressure monitoring and an urinary catheter to monitor diuresis
- Need for postoperative monitoring in intensive care
- Written informed consent;
Key exclusion criteria (9 listed)
- Acute kidney injury defined according to KDIGO guidelines;
- Pre-existing chronic renal disease;
- Heart failure;
- ARDS;
- Sepsis and Septic Shock;
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
Association between IR and PEEP
Time frame: Change from baseline to 60 minutes
Resistive index will be measured in both kidney and recorded using multifrequency convex probe.The association between positive end expiratory pressure and resistive index will be analyzed as the primary outcome.
1 secondary outcome
Association between PEEP and Hemodynamics Paramenters
Time frame: Change from baseline to 60 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2019.
- Individual participant dataSharing planned: No
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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.
Silvia De Rosa, MD principal investigator
Ospedale San Bortolo di Vicenza
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 Perfusion; Complications and Mechanical Ventilation Complication, run by St. Bortolo Hospital at 1 site 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 4 inclusion and 9 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 1 Feb 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Silvia De Rosa, MD (+393933098583, derosa.silvia@ymail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between IR and PEEP (time frame: Change from baseline to 60 minutes). 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 1 Feb 2019.