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

Sponsor
The First Hospital of Jilin University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05866250
Collaborator
(none)
400
6.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Doppler-based renal resistive index

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

Study Type:
Observational
Anticipated Enrollment :
400 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Anticipated Study Start Date :
Jun 20, 2023
Anticipated Primary Completion Date :
Sep 30, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
critically ill patients

All newly admitted ICU patients

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

Outcome Measures

Primary Outcome Measures

  1. The prognosis of AKI [72 hours]

    NO AKI, transient AKI, persistent AKI

Secondary Outcome Measures

  1. Recovery of kidney function [28 days]

    A decrease of serum creatinine, reversal of oliguria without diuretic therapy, and without need for renal replacement therapy.

  2. Mortality [28 days]

    Death or suivival

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • The First Hospital of Jilin University

Investigators

  • Principal Investigator: Dong Zhang, Director, The First Hospital of Jilin University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Dong Zhang, Director, The First Hospital of Jilin University
ClinicalTrials.gov Identifier:
NCT05866250
Other Study ID Numbers:
  • DongZhang
First Posted:
May 19, 2023
Last Update Posted:
May 19, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dong Zhang, Director, The First Hospital of Jilin University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 19, 2023