Anemia Clinical Trial
Official title:
Effects of Red Blood Cells Transfusion on Renal Resistivity Index and Renal Venous Stasis Index
NCT number | NCT04194047 |
Other study ID # | RRIRBC |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 1, 2020 |
Est. completion date | September 1, 2022 |
Verified date | September 2022 |
Source | Università degli Studi di Ferrara |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
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 |
Country | Name | City | State |
---|---|---|---|
Italy | Università di Ferrara | Ferrara |
Lead Sponsor | Collaborator |
---|---|
Università degli Studi di Ferrara |
Italy,
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
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 |
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