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

NCT03969914 | Completed DMC

• 1 other identifier: RRIPEEP
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Respiratory Distress Syndrome, Adult; Respiration, Artificial; Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Occurence of AKI

  AKI will be defined according to Kidney Disease: Improving Global Outcomes (KDIGO) criteria

  once a day until day 7

Secondary Outcomes (1)

• Change in RRI at different level of PEEP

  One a day until day 5

Study Arms (1)

Critically ill ventilated patients

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

Procedure: PEEP changes

Interventions

PEEP changes PROCEDURE

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

Critically ill ventilated patients

Eligibility Criteria

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

Study Population

Cohort of critically ill patients

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Università degli Studi di Ferrara: lead

Study Sites (2)

Università di Ferrara

Ferrara, 44121, Italy

Location

Università di Siena

Siena, 53100, Italy

Location

Related Publications (1)

• Fogagnolo A, Grasso S, Morelli E, Murgolo F, Di Mussi R, Vetrugno L, La Rosa R, Volta CA, Spadaro S. Impact of positive end-expiratory pressure on renal resistive index in mechanical ventilated patients. J Clin Monit Comput. 2024 Oct;38(5):1145-1153. doi: 10.1007/s10877-024-01172-z. Epub 2024 May 21.

  PMID: 38771490 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome; Respiratory Aspiration; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 28, 2019
• First Posted: May 31, 2019
• Study Start: May 1, 2019
• Primary Completion: May 1, 2020
• Study Completion: June 15, 2020
• Last Updated: April 28, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

IT (2)