Effects of Red Blood Cells Transfusion on Renal Blood Flow

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04194047
• Other study ID #: RRIRBC
• Status: Completed
• Start date: March 1, 2020
• Est. completion date: September 1, 2022

Study information

• Verified date: September 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. 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Anemia
• Fluid Overload
• Transfusion Reaction
• Transfusion-Associated Circulatory Overload

Intervention

Other:
• Transfusion
RBC transfusion (1 unit)
• Crystalloids infusion
Infusion of 500 ml of balanced crystalloids

Locations

Country	Name	City	State
Italy	Università di Ferrara	Ferrara

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi di Ferrara

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Husain-Syed F, Birk HW, Ronco C, Schörmann 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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
Primary	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	Occurence of AKI	Occurence of AKI as defined by Kidney Disease: Improving Global Outcomes (KDIGO)	Once a day for 7 days
Secondary	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
Secondary	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