NCT05866250

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
467

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2023

Shorter than P25 for all trials

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 19, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

5 months

First QC Date

May 10, 2023

Last Update Submit

May 14, 2024

Conditions

Keywords

acute kidney injuryrenal resistive indexprognosiscritically ill patients

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Recovery of kidney function

    28 days

  • Mortality

    28 days

Study Arms (1)

critically ill patients

All newly admitted ICU patients

Diagnostic Test: Doppler-based renal resistive index

Interventions

The kidney's interlobular or arcuate artery was preferentially selected and measured by pulse-wave Doppler.

critically ill patients

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All the critically ill patients

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Jilin Province People's Hospital

Changchun, Jlin, 130021, China

Location

The First Hospital of Jilin University

Changchun, Jlin, 130021, China

Location

The Third Affiliated Hospital of Changchung University

Changchun, Jlin, 130021, China

Location

Dunhua City Hospital

Dunhua, Jlin, 133799, China

Location

Jilin Central Hospital

Jilin, Jlin, 132011, China

Location

Meihekou Central Hospital

Meihekou, Jlin, 135099, China

Location

Jilin Siping Central People's Hospital

Siping, Jlin, 132011, China

Location

Related Publications (5)

  • 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.

    PMID: 26162677BACKGROUND
  • 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.

    PMID: 20862450BACKGROUND
  • 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.

    PMID: 34678845BACKGROUND
  • 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.

    PMID: 35074631BACKGROUND
  • 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.

    PMID: 30291377BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Dong Zhang, Director

    The First Hospital of Jilin University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
28 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

May 10, 2023

First Posted

May 19, 2023

Study Start

August 1, 2023

Primary Completion

December 30, 2023

Study Completion

March 1, 2024

Last Updated

May 16, 2024

Record last verified: 2024-05

Locations