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A Non-invasive Evaluation of Kidney-Lung Interactions

KIDNEY - LUNG INTERACTION: the Effect of End-expiratory Pressure on Renal Perfusion. Non-invasive Evaluation.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03747731
Acronym
KIDNEY-LUNG
Enrollment
109
Registered
2018-11-20
Start date
2018-11-19
Completion date
2019-11-19
Last updated
2019-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mechanical Ventilation Complication, Perfusion; Complications

Keywords

Renal blood perfusion, Mechanical ventilation

Brief 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. 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.

Interventions

None listed

Sponsors

St. Bortolo Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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;

Exclusion criteria

* 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; * 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;

Design outcomes

Primary

MeasureTime frameDescription
Association between IR and PEEPChange from baseline to 60 minutesResistive 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.

Secondary

MeasureTime frameDescription
Association between PEEP and Hemodynamics ParamentersChange from baseline to 60 minutesResistive 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

Other

MeasureTime frameDescription
Association between IR and Respiratory exchangesChange from baseline to 60 minutesResistive index will be measured in both kidney and recorded using multifrequency convex. PaO2 and PaCO2 will be analyzed at each PEEP level.

Countries

Italy

Contacts

Primary ContactSilvia De Rosa, MD
derosa.silvia@ymail.com+393933098583

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026