MULTIMODAL APPROACH IN THE DIAGNOSIS OF SEPTIC AKI

NCT07472452 | Not Yet Recruiting

• 1 other identifier: AEŞH-BADEK1-2026-025
• Study Type: observational
• Target: 130
• Locations: 0 countries
• Sites: N/A

Brief Summary

In recent studies, it has been reported that the renal resistance index is effective in detecting sepsis-related acute renal failure (SA-AKI) in the early period. Similarly, urinary biomarkers \[TIMP-2\]\*\[IGFBP-7\], released in response to tubular epithelial cell stress, have been reported to indicate the presence of acute renal injury (AKI) early on, before functional loss occurs (increased creatinine). This observational study aims to evaluate the renal resistance index and urinary biomarker variation in patients diagnosed with sepsis and to investigate their usefulness in the early detection of renal dysfunction that may develop after sepsis.

Conditions

Acute Kidney Injury; Sepsis; Critical Illness; Renal Resistive Index

Keywords

Renal Resistive Index (RRI); Cell Cycle Arrest Biomarkers; Intensive Care Units; Sepsis; Sepsis-Associated AKI

Outcome Measures

Primary Outcomes (5)

• Renal resistance index (RRI)

  Measurement of renal resistance index by Doppler ultrasonography immediately after sepsis diagnosis

  Immediately after sepsis diagnosis (T0, baseline, first measurement)

• Renal resistance index (RRI)

  Measurement of renal resistance index by Doppler ultrasonography after sepsis diagnosis

  24 hours after sepsis diagnosis (T24, second measurement)

• Renal resistance index (RRI)

  Measurement of renal resistance index by Doppler ultrasonography after sepsis diagnosis

  48 hours after sepsis diagnosis (T48, third measurement)

• Urine [TIMP-2]•[IGFBP-7] biomarker

  Measurement of \[TIMP-2\]•\[IGFBP-7\] in urine immediately after diagnosis of sepsis

  Immediately after diagnosis of sepsis (T0)

• Urine [TIMP-2]•[IGFBP-7] biomarker

  Measurement of \[TIMP-2\]•\[IGFBP-7\] in urine after sepsis diagnosis

  24 hours after diagnosis of sepsis (T24)

Secondary Outcomes (4)

• Time to onset of sepsis-associated acute kidney injury (SA-AKI)

  Up to 1 week after sepsis diagnosis

• Need for Renal Replacement Therapy (RRT) After Sepsis Diagnosis

  Up to 1 week after sepsis diagnosis

• Length of ICU stay

  through study completion, an average of 1 year

• Length of hospital stay

  through study completion, an average of 1 year

Study Arms (1)

Sepsis ICU Cohort

Adult patients (≥ 18 years of age) who are admitted to the intensive care unit with sepsis or who are diagnosed with sepsis during their admission and for whom bedside renal Doppler ultrasonography is feasible will be included in the study. Participants' Renal Resistive Index (RRI) measurements will be evaluated immediately after sepsis diagnosis (T0), at 24 hours (T24), and at 48 hours (T48). Urinary \[TIMP-2\]\*\[IGFBP-7\] measurements will be taken immediately after sepsis diagnosis (T0) and at 24 hours (T24). Clinical and laboratory data of the patients included in the study will be recorded for up to 72 hours after sepsis diagnosis. No treatment will be administered to the patients by the researchers; all medical care will be provided according to standard practice.

Diagnostic Test: Renal Resistive Index (RRI) Doppler Ultrasound; Diagnostic Test: Urinary TIMP-2 and IGFBP-7 biomarkers

Interventions

Renal Resistive Index (RRI) Doppler Ultrasound DIAGNOSTIC_TEST

Doppler ultrasonography will measure RRI immediately after sepsis diagnosis (T0), at 24 hours (T24), and at 48 hours (T48).

Sepsis ICU Cohort

Urinary TIMP-2 and IGFBP-7 biomarkers DIAGNOSTIC_TEST

Urine samples for \[TIMP-2\]\*\[IGFBP-7\] biomarker measurement will be collected immediately after sepsis diagnosis (T0) and 24 hours later (T24).

Sepsis ICU Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive adults admitted with sepsis to the intensive care units of Etlik Şehir Hastanesi, Ankara, Türkiye. Participants will be enrolled from a single tertiary center serving a broad urban referral population. Recruitment occurs during routine ICU care, with bedside Doppler ultrasound and urine sampling scheduled per protocol; no investigator-assigned treatments are given.

You may qualify if:

• Adults ≥18 years
• Diagnosis of sepsis (per Sepsis-3 clinical criteria)
• RRI measurement feasible at bedside
• Informed consent from participant or legally authorized representative

You may not qualify if:

• End-stage kidney disease (chronic dialysis) or baseline eGFR \<15mL/min/1.73 m²
• Kidney transplant recipient
• Anatomic/technical barrier precluding reliable renal Doppler (RRI) assessment
• Pregnancy

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

MeSH Terms

Conditions

Acute Kidney Injury; Sepsis; Critical Illness

Interventions

Ultrasonography, Doppler

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Eda Macit Aydın, M.D., M.D.

CONTACT

+90 312 797 00 00; edamct@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Intensive Care Specialist, M.D.

Study Record Dates

• First Submitted: February 7, 2026
• First Posted: March 16, 2026
• Study Start: March 30, 2026
• Primary Completion: June 30, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share