Mechanical Ventilation Complication Clinical Trial
— KIDNEY-LUNGOfficial title:
KIDNEY - LUNG INTERACTION: the Effect of End-expiratory Pressure on Renal Perfusion. Non-invasive Evaluation.
NCT number | NCT03747731 |
Other study ID # | 88/18 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | November 19, 2018 |
Est. completion date | November 19, 2019 |
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.
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; |
Country | Name | City | State |
---|---|---|---|
Italy | San Bortolo Hospital | Vicenza |
Lead Sponsor | Collaborator |
---|---|
St. Bortolo Hospital |
Italy,
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 |
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