A Non-invasive Evaluation of Kidney-Lung Interactions

Mechanical Ventilation Complication Clinical Trial

— KIDNEY-LUNG  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03747731
• Other study ID #: 88/18
• Status: Recruiting
• Start date: November 19, 2018
• Est. completion date: November 19, 2019

Study information

• Verified date: November 2018
• Source: St. Bortolo Hospital
• Contact: Silvia De Rosa, MD
• Phone: +393933098583
• Email: derosa.silvia[@]ymail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 109
• Est. completion date: November 19, 2019
• Est. primary completion date: May 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Mechanical Ventilation Complication
• Perfusion; Complications

Locations

Country	Name	City	State
Italy	San Bortolo Hospital	Vicenza

Sponsors (1)

Lead Sponsor	Collaborator
St. Bortolo Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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