A Non-invasive Evaluation of Kidney-Lung Interactions (KIDNEY-LUNG)

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.

Study Overview

• Status: Unknown
• Conditions: Mechanical Ventilation Complication; Perfusion; Complications

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 Type: Observational
• Enrollment (Anticipated): 109

Contacts and Locations

Study Locations

• Italy
  • Vicenza, Italy, 36100
    • Recruiting
    • San Bortolo Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing surgery and with the need for ventilatory support for the intensive care unit

Description

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;

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from baseline to 60 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Change from baseline to 60 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association between IR and Respiratory exchanges	Resistive index will be measured in both kidney and recorded using multifrequency convex. PaO2 and PaCO2 will be analyzed at each PEEP level.	Change from baseline to 60 minutes

Collaborators and Investigators

• Sponsor: St. Bortolo Hospital
• Investigators: Principal Investigator: Silvia De Rosa, MD, Ospedale San Bortolo di Vicenza

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 19, 2018
• Primary Completion (ANTICIPATED): May 19, 2019
• Study Completion (ANTICIPATED): November 19, 2019

Study Registration Dates

• First Submitted: November 18, 2018
• First Submitted That Met QC Criteria: November 18, 2018
• First Posted (ACTUAL): November 20, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 1, 2019
• Last Update Submitted That Met QC Criteria: January 31, 2019
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Mechanical ventilation; Renal blood perfusion
• Other Study ID Numbers: 88/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No