A Non-invasive Evaluation of Kidney-Lung Interactions

NCT ID: NCT03747731

Last Updated: 2019-02-01

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 109 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-11-19
• Study Completion Date: 2019-11-19

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.

Conditions

Perfusion; Complications; Mechanical Ventilation Complication

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Bortolo Hospital

OTHER

Sponsor Role: lead

Responsible Party

Silvia De Rosa

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Silvia De Rosa, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale San Bortolo di Vicenza

Locations

San Bortolo Hospital

Vicenza, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Silvia De Rosa, MD

Role: CONTACT

derosa.silvia@ymail.com

+393933098583

Facility Contacts

Silvia De Rosa, MD

Role: primary

derosa.silvia@ymail.com

Other Identifiers

88/18

Identifier Type: -

Identifier Source: org_study_id