Effects of Red Blood Cells Transfusion on Renal Blood Flow

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

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

Study Overview

• Status: Completed
• Conditions: Anemia; Acute Kidney Injury; Fluid Overload; Transfusion-Associated Circulatory Overload
• Intervention / Treatment: Other: Transfusion; Other: Crystalloids infusion

• Study Type: Observational
• Enrollment (Actual): 33

Contacts and Locations

Study Locations

• Italy
  • Ferrara, Italy, 44121
    • Università di Ferrara

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Cohort of critically ill patients

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
RBC group; Patients who received RBC transfusion	Other: Transfusion; RBC transfusion (1 unit)
crystalloids group; Patients who received fluid resuscitation with crystalloids	Other: Crystalloids infusion; Infusion of 500 ml of balanced crystalloids
control group; Patients not receiving RBC nor crystalloids

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in renal resistivity index (RRI) after intervention	To compare change in RRI after intervention between groups. Values over>0.70 are considered pathological. Higher values means worse outcome.	after 60 minute from intervention
Change Renal Venous Stasis Index (RSVI) after intervention	To compare change in RSVI after intervention between groups. Under physiological conditions, the index is zero. Higher values means worse outcome.	after 60 minute from intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurence of AKI	Occurence of AKI as defined by Kidney Disease: Improving Global Outcomes (KDIGO)	Once a day for 7 days
Variation in renal resistivity index (RRI)	To compare change in RRI after intervention between groupsValues over>0.70 are considered pathological. Higher values means worse outcome.	after 24 hours from intervention
Variation in Renal Venous Stasis Index (RSVI)	To compare change in RSVI after intervention between groups. Under physiological conditions, the index is zero. Higher values means worse outcome.	after 24 hours from intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
correlation between arterial-venous oxygen differences and changes in renal resistivity index (RRI) after intervention	RRI values over>0.70 are considered pathological. Higher values means worse outcome.	after 24 hours from intervention
correlation between arterial-venous oxygen differences and changes in Renal Venous Stasis Index (RSVI)	Under physiological conditions, the index is zero. Higher values means worse outcome.	after 24 hours from intervention

Collaborators and Investigators

• Sponsor: Università degli Studi di Ferrara

Publications and helpful links

General Publications

• Husain-Syed F, Birk HW, Ronco C, Schormann T, Tello K, Richter MJ, Wilhelm J, Sommer N, Steyerberg E, Bauer P, Walmrath HD, Seeger W, McCullough PA, Gall H, Ghofrani HA. Doppler-Derived Renal Venous Stasis Index in the Prognosis of Right Heart Failure. J Am Heart Assoc. 2019 Nov 5;8(21):e013584. doi: 10.1161/JAHA.119.013584. Epub 2019 Oct 19.
• Zafrani L, Ergin B, Kapucu A, Ince C. Blood transfusion improves renal oxygenation and renal function in sepsis-induced acute kidney injury in rats. Crit Care. 2016 Dec 20;20(1):406. doi: 10.1186/s13054-016-1581-1.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): September 1, 2022

Study Registration Dates

• First Submitted: December 8, 2019
• First Submitted That Met QC Criteria: December 8, 2019
• First Posted (Actual): December 11, 2019

Study Record Updates

• Last Update Posted (Actual): September 13, 2022
• Last Update Submitted That Met QC Criteria: September 8, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Kidney Diseases; Urologic Diseases; Hematologic Diseases; Renal Insufficiency; Acute Kidney Injury; Transfusion Reaction
• Other Study ID Numbers: RRIRBC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No