Clinical trial NCT05866250: Dynamic Change of Doppler-based Renal Resistive Index in Predicting Renal Recovery
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Keywords: acute kidney injury
renal resistive index
prognosis
critically ill patients
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2023-05-19
Enrollment: 467
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All the critically ill patients

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The prognosis of AKI
timeFrame: 72 hours
Secondary outcomes:
measure: Recovery of kidney function
timeFrame: 28 days
measure: Mortality
timeFrame: 28 days
Other outcomes:
Locations:
city: Changchun
country: China
facility: Jilin Province People's Hospital
state: Jlin
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jlin
city: Changchun
country: China
facility: The Third Affiliated Hospital of Changchung University
state: Jlin
city: Dunhua
country: China
facility: Dunhua City Hospital
state: Jlin
city: Jilin
country: China
facility: Jilin Central Hospital
state: Jlin
city: Meihekou
country: China
facility: Meihekou Central Hospital
state: Jlin
city: Siping
country: China
facility: Jilin Siping Central People's Hospital
state: Jlin
Study officials:
affiliation: The First Hospital of Jilin University
name: Dong Zhang, Director
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
citation: 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.