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OpenTrials
Completed

NCT Number: NCT04194047

Effects of Red Blood Cells Transfusion on Renal Blood Flow

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. It is associated with the occurrence of acute kidney injury (AKI). Many parameters have been described as influential on the values of renal RI. Red blood cell (RBC) transfusion were shown to be able to increase renal oxygenation in animal model, whereas crystalloid resuscitation did not. We sought to describe the different effect of crystalloids infusion and RBC transfusion on renal blood flow, as evaluated with doppler ultrasound

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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

  • Age > 18 and < 90
  • Hemoglobin ≥7 and ≤ 10 g/dl

Exclusion criteria

  • Ultrasound RRI evaluation non available
  • Patients with arrhythmia
  • Pregnancy
  • Refusal to give consent
  • History of renal transplantation
  • Central venous access in superior vena cava not available Critical active bleeding

Treatment and study plan

Transfusion

Other

RBC transfusion (1 unit)

Crystalloids infusion

Other

Infusion of 500 ml of balanced crystalloids

Primary outcomes

  1. Change in renal resistivity index (RRI) after intervention

    Time frame: after 60 minute from intervention

    To compare change in RRI after intervention between groups. Values over>0.70 are considered pathological. Higher values means worse outcome.

  2. Change Renal Venous Stasis Index (RSVI) after intervention

    Time frame: after 60 minute from intervention

    To compare change in RSVI after intervention between groups. Under physiological conditions, the index is zero. Higher values means worse outcome.

Secondary outcomes

  1. Occurence of AKI

    Time frame: Once a day for 7 days

    Occurence of AKI as defined by Kidney Disease: Improving Global Outcomes (KDIGO)

  2. Variation in renal resistivity index (RRI)

    Time frame: after 24 hours from intervention

    To compare change in RRI after intervention between groupsValues over>0.70 are considered pathological. Higher values means worse outcome.

  3. Variation in Renal Venous Stasis Index (RSVI)

    Time frame: after 24 hours from intervention

    To compare change in RSVI after intervention between groups. Under physiological conditions, the index is zero. Higher values means worse outcome.

Other outcomes

  1. correlation between arterial-venous oxygen differences and changes in renal resistivity index (RRI) after intervention

    Time frame: after 24 hours from intervention

    RRI values over>0.70 are considered pathological. Higher values means worse outcome.

  2. correlation between arterial-venous oxygen differences and changes in Renal Venous Stasis Index (RSVI)

    Time frame: after 24 hours from intervention

    Under physiological conditions, the index is zero. Higher values means worse outcome.

Sponsors and collaborators

Lead sponsor

Università degli Studi di Ferrara

Other

Registry information

Official study title

Effects of Red Blood Cells Transfusion on Renal Resistivity Index and Renal Venous Stasis Index

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 11, 2019
Registry last updated
Sep 13, 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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