Effects of Red Blood Cells Transfusion on Renal Blood Flow

NCT04194047 | Completed

• 1 other identifier: RRIRBC
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

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. 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

Conditions

Acute Kidney Injury; Transfusion-Associated Circulatory Overload; Anemia; Fluid Overload

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Occurence of AKI

  Once a day for 7 days

• Variation in renal resistivity index (RRI)

  after 24 hours from intervention

• Variation in Renal Venous Stasis Index (RSVI)

  after 24 hours from intervention

Other Outcomes (2)

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

  after 24 hours from intervention

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

  after 24 hours from intervention

Study Arms (3)

RBC group

Patients who received RBC transfusion

Other: Transfusion

crystalloids group

Patients who received fluid resuscitation with crystalloids

Other: Crystalloids infusion

control group

Patients not receiving RBC nor crystalloids

Interventions

Transfusion OTHER

RBC transfusion (1 unit)

RBC group

Crystalloids infusion OTHER

Infusion of 500 ml of balanced crystalloids

crystalloids group

Eligibility Criteria

• Age: 18 Years - 90 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:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Università degli Studi di Ferrara: lead

Study Sites (1)

Università di Ferrara

Ferrara, 44121, Italy

Location

Related Publications (2)

• 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.

  PMID: 27993148 BACKGROUND

• 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.

  PMID: 31630601 BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury; Transfusion Reaction; Anemia; Edema

Interventions

Blood Transfusion

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

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: December 8, 2019
• First Posted: December 11, 2019
• Study Start: March 1, 2020
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: September 13, 2022

Record last verified: 2022-09

Locations

IT (1)