Dynamic Change of Doppler-based Renal Resistive Index in Predicting Renal Recovery

Acute Kidney Injury Clinical Trial

— DRRRI  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05866250
• Other study ID #: DongZhang
• Status: Completed
• Start date: August 1, 2023
• Est. completion date: March 1, 2024

Study information

• Verified date: May 2024
• Source: The First Hospital of Jilin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 467
• Est. completion date: March 1, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients admitted to the ICU within 24 h of admission.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

Diagnostic Test:
• Doppler-based renal resistive index
The kidney's interlobular or arcuate artery was preferentially selected and measured by pulse-wave Doppler.

Locations

Country	Name	City	State
China	Jilin Province People's Hospital	Changchun	Jlin
China	The First Hospital of Jilin University	Changchun	Jlin
China	The Third Affiliated Hospital of Changchung University	Changchun	Jlin
China	Dunhua City Hospital	Dunhua	Jlin
China	Jilin Central Hospital	Jilin	Jlin
China	Meihekou Central Hospital	Meihekou	Jlin
China	Jilin Siping Central People's Hospital	Siping	Jlin

Sponsors (1)

Lead Sponsor	Collaborator
The First Hospital of Jilin University

Country where clinical trial is conducted

China, 

References & Publications (5)

Darmon 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. — View Citation

Darmon 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. — View Citation

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. — View Citation

Saade 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. — View Citation

Schnell 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	72 hours
Secondary	Recovery of kidney function	A decrease of serum creatinine, reversal of oliguria without diuretic therapy, and without need for renal replacement therapy.	28 days
Secondary	Mortality	Death or suivival	28 days