Acute Kidney InjuryNCT04194047
Effects of Red Blood Cells Transfusion on Renal Blood Flow
An observational study of Acute Kidney Injury and Transfusion-Associated Circulatory Overload, run by Università degli Studi di Ferrara at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Kidney Injury, Transfusion-Associated Circulatory Overload, Anemia
- What is being tested?
- Transfusion and Crystalloids infusion
- Type of treatment
- Injection or infusion
- How many people
- 33 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2020to 1 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cohort of critically ill patients
Who may be able to join
- Age > 18 and < 90
- Hemoglobin ≥7 and ≤ 10 g/dl
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Being tested
- Transfusion, Crystalloids infusion
- Medical subject headings
- Acute Kidney Injury, Transfusion Reaction, Anemia, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TransfusionOther
RBC transfusion (1 unit)
Crystalloids infusionOther
Infusion of 500 ml of balanced crystalloids
| Study group | Role | What they receive |
|---|---|---|
| RBC group | Patients who received RBC transfusion Receives: Other: Transfusion | |
| crystalloids group | Patients who received fluid resuscitation with crystalloids Receives: Other: Crystalloids infusion | |
| control group | Patients not receiving RBC nor crystalloids |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: after 60 minute from intervention
Secondary outcomes (3)
Occurence of AKI
Occurence of AKI as defined by Kidney Disease: Improving Global Outcomes (KDIGO)
Measured: 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.
Measured: 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.
Measured: after 24 hours from intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start1 Mar 2020
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alberto Fogagnolo, Università degli Studi di Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04194047
- Sponsor's protocol ID
- RRIRBC
- Status last verified
- Sep 2022
- First submitted
- 8 Dec 2019
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 27993148Husain-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.
PubMed 31630601
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Red Blood Cells Transfusion on Renal Resistivity Index and Renal Venous Stasis Index
- ClinicalTrials.gov ID
- NCT04194047
- Acronym / sponsor ID
- RRIRBC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Università degli Studi di FerraraUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 11 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RBC group | – | Other: TransfusionPatients who received RBC transfusion |
| crystalloids group | – | Other: Crystalloids infusionPatients who received fluid resuscitation with crystalloids |
| control group | – | –Patients not receiving RBC nor crystalloids |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cohort of critically ill patients
Key inclusion criteria (2 listed)
- Age > 18 and < 90
- Hemoglobin ≥7 and ≤ 10 g/dl
Key exclusion criteria (6 listed)
- Ultrasound RRI evaluation non available
- Patients with arrhythmia
- Pregnancy
- Refusal to give consent
- History of renal transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TransfusionRBC transfusion (1 unit) | Other | RBC group |
| Crystalloids infusionInfusion of 500 ml of balanced crystalloids | Other | crystalloids group |
Primary outcome
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.
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.
3 secondary outcomes
Occurence of AKI
Time frame: Once a day for 7 days
Variation in renal resistivity index (RRI)
Time frame: after 24 hours from intervention
Variation in Renal Venous Stasis Index (RSVI)
Time frame: after 24 hours from intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
- Background: PubMed 27993148Zafrani 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.
- Background: PubMed 31630601Husain-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and Transfusion-Associated Circulatory Overload, run by Università degli Studi di Ferrara at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in renal resistivity index (RRI) after intervention (time frame: after 60 minute from intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04194047, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2022.