NCT06995222

Brief Summary

Acute kidney injury(AKI) is defined in the KDIGO guidelines as a ≥0.3 mg/dL (≥26.5 micromol/L) increase in serum creatinine in the previous 48 hours or a ≥1.5-fold increase in serum creatinine from baseline, known or presumed to have occurred in the previous seven days, or a urine volume \<0.5 mL/kg/hour for six hours. Given the high morbidity and mortality associated with AKI, many investigators are studying several novel biomarkers to detect AKI progression earlier, identify etiologies and predict outcomes. However, the utilisation of these novel biomarkers may be constrained by reimbursement considerations. The renal resistive index (RRI) is a well-established metric for evaluating renal perfusion; however, its application in the context of AKI has been a subject of recent debate. While RRI has been utilised to demonstrate perfusion in acute and chronic renal diseases, particularly in conjunction with ultrasonography, its efficacy remains a subject of scientific discourse. In addition, Boddi reported that RRI is a strong indicator of mortality and a diagnostic marker, especially in patients with persistent AKI. The present study aims to evaluate the appropriateness of using the RRI, a non-invasive procedure, to determine the progression of AKI stages and the need for renal replacement therapy in patients hospitalised in intensive care units.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
2mo left

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress90%
Jan 2025Jul 2026

Study Start

First participant enrolled

January 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 29, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

May 29, 2025

Status Verified

April 1, 2025

Enrollment Period

1.5 years

First QC Date

April 4, 2025

Last Update Submit

May 27, 2025

Conditions

Keywords

akut kidney injuryrenal resistive indexrenal replacement therapyintensive care

Outcome Measures

Primary Outcomes (1)

  • Akut kidney injury progression

    Patients admitted to our intensive care clinic with a diagnosis of AKI stage 1-2(according to KDIGO staging) will have RI measurement with Doppler Ulsanography within the first 24 hours of admission. Patients will be followed up daily from the time of measurement until the end of the study period and their progression to AKI stage 3(according to KDIGO staging) will be recorded. Patients will be monitored throughout the study. A comparison will be made between the groups that developed AKI stage 3(according to KDIGO staging) and those that did not develop AKI stage 3 during the study.

    14 days

Secondary Outcomes (4)

  • 14th day mortality rate

    14 days

  • 28th day mortality rate

    28 days

  • Length of stay in the intensive care unit

    18 months

  • Need for renal replacement therapy (RRT)

    14 days

Interventions

Renal resistive index uses doppler ultrasonography which assesses blood flow velocity in the renal arteries. The Renal Resistive Index (RI) is calculated by substracting diastolic velocity from systolic velocity then dividing result by systolic velocity Where: Systolic velocity is the peak velocity of the blood flow during the systolic phase of the cardiac cycle. Diastolic velocity is the velocity of blood flow during the diastolic phase.

Eligibility Criteria

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

Male and female patients over 18 years of age who met KDIGO ABH stage 1 or stage 2 criteria and were hemodynamically stable in the first 24 hours of admission to the Internal Medicine Intensive Care Unit of Gülhane Training and Research Hospital, University of Health Sciences.

You may qualify if:

  • Being over 18 years of age
  • Having KDIGO stage 1 or stage 2 acute kidney injury within the first 24 hours of admission

You may not qualify if:

  • \. Patients who did not provide a consent form for participation in the study 2. Patients under 18 years of age 3. Pregnant women 4. Patients with postrenal acute kidney injury 5. Patients 24 hours after the diagnosis of acute kidney injury 6. Patients with acute kidney injury in the recovery period 7. Patients who were evaluated as KDIGO ABH stage 3 during hospitalization 8. Patients with a known history of renal artery stenosis 9. Patients with a diagnosis of cardiac arrhythmia 10. Patients with a diagnosis of chronic kidney disease and a glomerular filtration rate below 30 ml/min/1.73m2 11. Patients with intra-abdominal pressure above 20 mmHg 12. Patients with a hospitalization period of less than 24 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gulhane Education and Research Hospital Ankara Türkiye

Ankara, Türkiye, 06010, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • Gibney N, Hoste E, Burdmann EA, Bunchman T, Kher V, Viswanathan R, Mehta RL, Ronco C. Timing of initiation and discontinuation of renal replacement therapy in AKI: unanswered key questions. Clin J Am Soc Nephrol. 2008 May;3(3):876-80. doi: 10.2215/CJN.04871107. Epub 2008 Mar 5.

    PMID: 18322044BACKGROUND

MeSH Terms

Interventions

Ultrasonography, Doppler

Intervention Hierarchy (Ancestors)

UltrasonographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Gürhan T associate professor doctor

    Gulhane Education and Research Hospital Ankara Türkiye

    STUDY DIRECTOR

Central Study Contacts

Mete E specialist

CONTACT

Gürhan T associate professor doctor

CONTACT

Study Design

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

Study Record Dates

First Submitted

April 4, 2025

First Posted

May 29, 2025

Study Start

January 1, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

May 29, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

research results will be published and the data used in the publication will be available for sharing upon request

Shared Documents
STUDY PROTOCOL
Time Frame
January 01, 2025 - July 01, 2026
Access Criteria
During the publication phase, it will be shared with the relevant broadcasting organization via the official e-mail address, and patient identification information will not be specified.

Locations