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

October 30, 2023 updated by: Dong Zhang, The First Hospital of Jilin University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jlin
      • Changchun, Jlin, China, 130021
        • Recruiting
        • The First Hospital of Jilin University
        • Contact:
      • Changchun, Jlin, China, 130021
        • Recruiting
        • Jilin Province People's Hospital
        • Contact:
      • Changchun, Jlin, China, 130021
        • Recruiting
        • The Third Affiliated Hospital of Changchung University
        • Contact:
      • Dunhua, Jlin, China, 133799
        • Recruiting
        • Dunhua City Hospital
        • Contact:
      • Jilin, Jlin, China, 132011
        • Recruiting
        • Jilin Central Hospital
        • Contact:
      • Meihekou, Jlin, China, 135099
        • Recruiting
        • Meihekou Central Hospital
        • Contact:
      • Siping, Jlin, China, 132011
        • Recruiting
        • Jilin Siping Central People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

All the critically ill patients

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recovery of kidney function
Time Frame: 28 days
A decrease of serum creatinine, reversal of oliguria without diuretic therapy, and without need for renal replacement therapy.
28 days
Mortality
Time Frame: 28 days
Death or suivival
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Hospital of Jilin University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Actual)

October 31, 2023

Study Completion (Estimated)

November 30, 2023

Study Registration Dates

First Submitted

May 10, 2023

First Submitted That Met QC Criteria

May 10, 2023

First Posted (Actual)

May 19, 2023

Study Record Updates

Last Update Posted (Actual)

November 1, 2023

Last Update Submitted That Met QC Criteria

October 30, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DongZhang

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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