Clinical trial NCT03747731: A Non-invasive Evaluation of Kidney-Lung Interactions
Official title: KIDNEY - LUNG INTERACTION: the Effect of End-expiratory Pressure on Renal Perfusion. Non-invasive Evaluation.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Perfusion; Complications
Mechanical Ventilation Complication
Keywords: Renal blood perfusion
Mechanical ventilation
Lead sponsor: St. Bortolo Hospital
Sponsor class: OTHER
First posted: 2018-11-20
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing surgery and with the need for ventilatory support for the intensive care unit

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Association between IR and PEEP
timeFrame: Change from baseline to 60 minutes
Secondary outcomes:
measure: Association between PEEP and Hemodynamics Paramenters
timeFrame: Change from baseline to 60 minutes
Other outcomes:
measure: Association between IR and Respiratory exchanges
timeFrame: Change from baseline to 60 minutes
Locations:
city: Vicenza
country: Italy
facility: San Bortolo Hospital
Study officials:
affiliation: Ospedale San Bortolo di Vicenza
name: Silvia De Rosa, MD
role: PRINCIPAL_INVESTIGATOR
References: