A Non-invasive Evaluation of Kidney-Lung Interactions

NCT03747731 | Unknown

• 1 other identifier: 88/18
• Study Type: observational
• Target: 109
• Locations: 1 country
• Sites: 1

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.

Conditions

Perfusion; Complications; Mechanical Ventilation Complication

Keywords

Renal blood perfusion; Mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Association between PEEP and Hemodynamics Paramenters

  Change from baseline to 60 minutes

Other Outcomes (1)

• Association between IR and Respiratory exchanges

  Change from baseline to 60 minutes

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• St. Bortolo Hospital: lead

Study Sites (1)

San Bortolo Hospital

Vicenza, 36100, Italy

RECRUITING

Study Officials

• Silvia De Rosa, MD

  Ospedale San Bortolo di Vicenza

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Silvia De Rosa, MD

CONTACT

+393933098583; derosa.silvia@ymail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: November 18, 2018
• First Posted: November 20, 2018
• Study Start: November 19, 2018
• Primary Completion: May 19, 2019
• Study Completion: November 19, 2019
• Last Updated: February 1, 2019

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)