Acute Kidney InjuryDRRRINCT05866250
Dynamic Change of Doppler-based Renal Resistive Index in Predicting Renal Recovery
An observational study of Acute Kidney Injury, run by The First Hospital of Jilin University at 7 sites in China.
Trial summary
The goal of this observational study is to observe the correlation between dynamic changes in the Doppler-based renal resistive index (RI) and the occurrence of persistent acute kidney injury (AKI) in critically ill patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Doppler-based renal resistive index
- How many people
- 467 participants
- Where
- 7 sitesChina
- Study dates
- 1 Aug 2023to 1 Mar 2024
- How long will I take part?
- 28 Days
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All the critically ill patients
Who may be able to join
- Patients admitted to the ICU within 24 h of admission.
Who cannot join
- Chronic kidney disease stage III-V;
- History of kidney transplantation;
- Previously known renal artery stenosis or renal vein thrombosis；
- Cardiac arrhythmia precluding renal Doppler measurement;
- Expected hospital stay < 72 h；
- Pregnant patients
- Last, patients with hospital stays < 72 h, since they could not be classified as having transient or persistent AKI according to our definitions, were secondarily excluded.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Jilin Province People's Hospital
Changchun, Jlin, 130021
The First Hospital of Jilin University
Changchun, Jlin, 130021
The Third Affiliated Hospital of Changchung University
Changchun, Jlin, 130021
Dunhua City Hospital
Dunhua, Jlin, 133799
Jilin Central Hospital
Jilin City, Jlin, 132011
Meihekou Central Hospital
Meihekou, Jlin, 135099
Jilin Siping Central People's Hospital
Siping, Jlin, 132011
About this study
Official title: Dynamic Change of Doppler-based Renal Resistive Index in Predicting Renal Recovery From Acute Kidney Injury in Critically Ill Patients: a Prospective Observational Multicenter Study
The goal of this observational study is to observe the correlation between dynamic changes in the Doppler-based renal resistive index (RI) and the occurrence of persistent acute kidney injury (AKI) in critically ill patients. The main questions it aims to answer are:
- Are dynamic changes of RI within 24 or 48 hours associated with the prognosis of AKI (NO AKI, transient AKI, persistent AKI)?
- what are the influencing factors of changes in RI? Participants will measure values of RI in patients at admission (0 hour), after 24 hours and after 48 hours, respectively, and collect characters such as age, sex, vital signs, Apache II, diagnosis, renal function, applied drugs, fluid, 72-hour renal function and renal replacement, followed renal replacement and the mortality rate at 28 days.
Read the detailed description
NO AKI is defined as No AKI occurred within 72 hour after ICU admission; Transient AKI is defined as AKI with recovery, which refers to the reduction in AKI stage ( (i.e., a decrease of serum creatinine, reversal of oliguria without diuretic therapy, and without need for renal replacement therapy) occurring with 72 hour after ICU admission; Persistent AKI is defined as AKI without recovery occurring with 72 hour after ICU admission.
- Conditions
- Acute Kidney Injury
- Being tested
- Doppler-based renal resistive index
- Keywords
- acute kidney injury, renal resistive index, prognosis, critically ill patients
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doppler-based renal resistive indexDiagnostic test
The kidney's interlobular or arcuate artery was preferentially selected and measured by pulse-wave Doppler.
| Study group | Role | What they receive |
|---|---|---|
| critically ill patients | All newly admitted ICU patients Receives: Diagnostic Test: Doppler-based renal resistive index |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prognosis of AKI
NO AKI, transient AKI, persistent AKI. Transient AKI refers to the reduction in AKI stage ( (a decrease of serum creatinine, reversal of oliguria without diuretic therapy, and without need for renal replacement therapy) occurring with 72 hour after ICU admission. Persistent AKI refers to AKI without recovery occurring within 72 hours after ICU admission.
Measured: 72 hours
Secondary outcomes (2)
Recovery of kidney function
A decrease of serum creatinine, reversal of oliguria without diuretic therapy, and without need for renal replacement therapy.
Measured: 28 days
Mortality
Death or suivival
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start1 Aug 2023
- Primary completion30 Dec 2023
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe sponsor's other registered studies.
- 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
- 467 participants (actual)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Zhang, The First Hospital of Jilin University
- Investigators
- Dong Zhang, Director, Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05866250
- Sponsor's protocol ID
- DongZhang
- Acronym
- DRRRI
- Status last verified
- May 2024
- First submitted
- 10 May 2023
- Last updated
- 16 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hoste EA, Bagshaw SM, Bellomo R, Cely CM, Colman R, Cruz DN, Edipidis K, Forni LG, Gomersall CD, Govil D, Honore PM, Joannes-Boyau O, Joannidis M, Korhonen AM, Lavrentieva A, Mehta RL, Palevsky P, Roessler E, Ronco C, Uchino S, Vazquez JA, Vidal Andrade E, Webb S, Kellum JA. Epidemiology of acute kidney injury in critically ill patients: the multinational AKI-EPI study. Intensive Care Med. 2015 Aug;41(8):1411-23. doi: 10.1007/s00134-015-3934-7. Epub 2015 Jul 11.
PubMed 26162677Darmon M, Schortgen F, Vargas F, Liazydi A, Schlemmer B, Brun-Buisson C, Brochard L. Diagnostic accuracy of Doppler renal resistive index for reversibility of acute kidney injury in critically ill patients. Intensive Care Med. 2011 Jan;37(1):68-76. doi: 10.1007/s00134-010-2050-y. Epub 2010 Sep 23.
PubMed 20862450Saade A, Bourmaud A, Schnell D, Darmon M; R2D2 Study Group. Performance of Doppler-Based Resistive Index and Semiquantitative Renal Perfusion in Predicting Persistent Acute Kidney Injury According to Operator Experience: Post Hoc Analysis of a Prospective Multicenter Study. Crit Care Med. 2022 Apr 1;50(4):e361-e369. doi: 10.1097/CCM.0000000000005372.
PubMed 34678845Schnell D, Bourmaud A, Reynaud M, Rouleau S, Merdji H, Boivin A, Benyamina M, Vincent F, Lautrette A, Leroy C, Cohen Y, Legrand M, Morel J, Terreaux J, Darmon M. Performance of renal Doppler to predict the occurrence of acute kidney injury in patients without acute kidney injury at admission. J Crit Care. 2022 Jun;69:153983. doi: 10.1016/j.jcrc.2021.12.017. Epub 2022 Jan 21.
PubMed 35074631Darmon M, Bourmaud A, Reynaud M, Rouleau S, Meziani F, Boivin A, Benyamina M, Vincent F, Lautrette A, Leroy C, Cohen Y, Legrand M, Morel J, Terreaux J, Schnell D. Performance of Doppler-based resistive index and semi-quantitative renal perfusion in predicting persistent AKI: results of a prospective multicenter study. Intensive Care Med. 2018 Nov;44(11):1904-1913. doi: 10.1007/s00134-018-5386-3. Epub 2018 Oct 5.
PubMed 30291377Fu Y, Ke L, Lv C, Wang Y, Zhang S, Yan J, Zhang X, Liu W, Hu Y, Zhang D, Li H. Early renal perfusion phenotypes and renal recovery in critically ill patients with or at risk for acute kidney injury: a prospective multicenter cohort study. Shock. 2026 Sep 7. doi: 10.1097/SHK.0000000000002936. Online ahead of print.
PubMed 42704056
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Change of Doppler-based Renal Resistive Index in Predicting Renal Recovery From Acute Kidney Injury in Critically Ill Patients: a Prospective Observational Multicenter Study
- ClinicalTrials.gov ID
- NCT05866250
- Acronym / sponsor ID
- DRRRI / DongZhang
- Conditions
- Acute Kidney Injury
- Keywords
- acute kidney injury, renal resistive index, prognosis, critically ill patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 467 participants (actual)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 19 May 2023 (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 goal of this observational study is to observe the correlation between dynamic changes in the Doppler-based renal resistive index (RI) and the occurrence of persistent acute kidney injury (AKI) in critically ill patients. The main questions it aims to answer are:
- Are dynamic changes of RI within 24 or 48 hours associated with the prognosis of AKI (NO AKI, transient AKI, persistent AKI)?
- what are the influencing factors of changes in RI? Participants will measure values of RI in patients at admission (0 hour), after 24 hours and after 48 hours, respectively, and collect characters such as age, sex, vital signs, Apache II, diagnosis, renal function, applied drugs, fluid, 72-hour renal function and renal replacement, followed renal replacement and the mortality rate at 28 days.
Detailed description
NO AKI is defined as No AKI occurred within 72 hour after ICU admission; Transient AKI is defined as AKI with recovery, which refers to the reduction in AKI stage ( (i.e., a decrease of serum creatinine, reversal of oliguria without diuretic therapy, and without need for renal replacement therapy) occurring with 72 hour after ICU admission; Persistent AKI is defined as AKI without recovery occurring with 72 hour after ICU admission.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 28 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| critically ill patients | – | Diagnostic Test: Doppler-based renal resistive indexAll newly admitted ICU patients |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All the critically ill patients
Key inclusion criteria (1 listed)
- Patients admitted to the ICU within 24 h of admission.
Key exclusion criteria (7 listed)
- Chronic kidney disease stage III-V;
- History of kidney transplantation;
- Previously known renal artery stenosis or renal vein thrombosis；
- Cardiac arrhythmia precluding renal Doppler measurement;
- Expected hospital stay < 72 h；
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 |
|---|---|---|
| Doppler-based renal resistive indexThe kidney's interlobular or arcuate artery was preferentially selected and measured by pulse-wave Doppler. | Diagnostic test | critically ill patients |
Primary outcome
The prognosis of AKI
Time frame: 72 hours
NO AKI, transient AKI, persistent AKI. Transient AKI refers to the reduction in AKI stage ( (a decrease of serum creatinine, reversal of oliguria without diuretic therapy, and without need for renal replacement therapy) occurring with 72 hour after ICU admission. Persistent AKI refers to AKI without recovery occurring within 72 hours after ICU admission.
2 secondary outcomes
Recovery of kidney function
Time frame: 28 days
Mortality
Time frame: 28 days
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 16 May 2024.
- Background: PubMed 26162677Hoste EA, Bagshaw SM, Bellomo R, Cely CM, Colman R, Cruz DN, Edipidis K, Forni LG, Gomersall CD, Govil D, Honore PM, Joannes-Boyau O, Joannidis M, Korhonen AM, Lavrentieva A, Mehta RL, Palevsky P, Roessler E, Ronco C, Uchino S, Vazquez JA, Vidal Andrade E, Webb S, Kellum JA. Epidemiology of acute kidney injury in critically ill patients: the multinational AKI-EPI study. Intensive Care Med. 2015 Aug;41(8):1411-23. doi: 10.1007/s00134-015-3934-7. Epub 2015 Jul 11.
- Background: PubMed 20862450Darmon M, Schortgen F, Vargas F, Liazydi A, Schlemmer B, Brun-Buisson C, Brochard L. Diagnostic accuracy of Doppler renal resistive index for reversibility of acute kidney injury in critically ill patients. Intensive Care Med. 2011 Jan;37(1):68-76. doi: 10.1007/s00134-010-2050-y. Epub 2010 Sep 23.
- Background: PubMed 34678845Saade A, Bourmaud A, Schnell D, Darmon M; R2D2 Study Group. Performance of Doppler-Based Resistive Index and Semiquantitative Renal Perfusion in Predicting Persistent Acute Kidney Injury According to Operator Experience: Post Hoc Analysis of a Prospective Multicenter Study. Crit Care Med. 2022 Apr 1;50(4):e361-e369. doi: 10.1097/CCM.0000000000005372.
- Background: PubMed 35074631Schnell D, Bourmaud A, Reynaud M, Rouleau S, Merdji H, Boivin A, Benyamina M, Vincent F, Lautrette A, Leroy C, Cohen Y, Legrand M, Morel J, Terreaux J, Darmon M. Performance of renal Doppler to predict the occurrence of acute kidney injury in patients without acute kidney injury at admission. J Crit Care. 2022 Jun;69:153983. doi: 10.1016/j.jcrc.2021.12.017. Epub 2022 Jan 21.
- Background: PubMed 30291377Darmon M, Bourmaud A, Reynaud M, Rouleau S, Meziani F, Boivin A, Benyamina M, Vincent F, Lautrette A, Leroy C, Cohen Y, Legrand M, Morel J, Terreaux J, Schnell D. Performance of Doppler-based resistive index and semi-quantitative renal perfusion in predicting persistent AKI: results of a prospective multicenter study. Intensive Care Med. 2018 Nov;44(11):1904-1913. doi: 10.1007/s00134-018-5386-3. Epub 2018 Oct 5.
- Derived from this study: PubMed 42704056Fu Y, Ke L, Lv C, Wang Y, Zhang S, Yan J, Zhang X, Liu W, Hu Y, Zhang D, Li H. Early renal perfusion phenotypes and renal recovery in critically ill patients with or at risk for acute kidney injury: a prospective multicenter cohort study. Shock. 2026 Sep 7. doi: 10.1097/SHK.0000000000002936. Online ahead of print.
- 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.
Dong Zhang, Director principal investigator
The First Hospital of Jilin University
7 sites 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, run by The First Hospital of Jilin University at 7 sites in China.
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 1 inclusion and 7 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 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. 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?
The prognosis of AKI (time frame: 72 hours). 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 NCT05866250, which also lists 6 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 16 May 2024; AzTrials last refreshed its copy on 6 Nov 2026.