PEEP-induced Changed in RRI as Physiological Background of Ventilator-induced Kidney Injury

Acute Kidney Injury Clinical Trial

— PRE-VIKI  

Official title:

PEEP-induced Changed in RRI as Physiological Background of Ventilator-induced Kidney Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03969914
• Other study ID #: RRIPEEP
• Status: Completed
• Start date: May 1, 2019
• Est. completion date: June 15, 2020

Study information

• Verified date: April 2022
• Source: Università degli Studi di Ferrara
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The renal Doppler resistive index (RRI) is a noninvasive tool that has been used to assess renal perfusion in the intensive care unit (ICU) setting. Many parameters have been described as influential on the values of renal RI. Mechanical ventilation is associated with significant increases in the risk of acute kidney injury (AKI). Ventilator-induced kidney injury (VIKI) is believed to occur due to changes in hemodynamics that impair renal perfusion. The investigators hypothesized that patients who need mechanical ventilation should have a different response in RRI when different levels of Positive end expiratory pressure (PEEP) are applied. Investigators wish to describe changing in RRI due to changes in PEEP and to verify whether these changes could partially explain the occurrence of VIKI

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: June 15, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients admitted to ICU with expected mechanical ventilation >48h

Exclusion Criteria:

• Ultrasound RRI evaluation non available
• Patients with arrhythmia
• Pregnancy

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Lung Injury
• Respiration, Artificial
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Wounds and Injuries

Intervention

Procedure:
• PEEP changes
All patients will be ventilated with a tidal volume of 6 ml/kg before the RRI assessment. Further, three level of PEEP (5, 10 and 15 cmH2O) will be randomly set. For each levels of PEEP, the RRI will be evaluated

Locations

Country	Name	City	State
Italy	Università di Ferrara	Ferrara
Italy	Università di Siena	Siena

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi di Ferrara

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurence of AKI	AKI will be defined according to Kidney Disease: Improving Global Outcomes (KDIGO) criteria	once a day until day 7
Secondary	Change in RRI at different level of PEEP	To compare median difference of RRI at PEEP 5 and PEEP 15 in patients who will develop (or not) AKI	One a day until day 5