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OpenTrials
Completed

NCT Number: NCT03969914

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

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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

Primary outcomes

  1. Occurence of AKI

    Time frame: once a day until day 7

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

Secondary outcomes

  1. Change in RRI at different level of PEEP

    Time frame: One a day until day 5

    To compare median difference of RRI at PEEP 5 and PEEP 15 in patients who will develop (or not) AKI

Sponsors and collaborators

Lead sponsor

Università degli Studi di Ferrara

Other

Registry information

Acronym: PRE-VIKI

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 31, 2019
Registry last updated
Apr 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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