MULTIMODAL APPROACH IN THE DIAGNOSIS OF SEPTIC AKI
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAnkara Etlik City Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults ≥18 years
Diagnosis of sepsis (per Sepsis-3 clinical criteria)
RRI measurement feasible at bedside
Informed consent from participant or legally authorized representative
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Renal Resistive Index (RRI) Doppler Ultrasound
Diagnostic testDoppler ultrasonography will measure RRI immediately after sepsis diagnosis (T0), at 24 hours (T24), and at 48 hours (T48).
Urinary TIMP-2 and IGFBP-7 biomarkers
Diagnostic testUrine samples for \[TIMP-2\]\*\[IGFBP-7\] biomarker measurement will be collected immediately after sepsis diagnosis (T0) and 24 hours later (T24).
Treatment groups
130 Participants
are divided into 1 treatment groupGroup A: Sepsis ICU Cohort2 interventions
Trial outcomes
Primary outcomes
1
Renal resistance index (RRI)
Measurement of renal resistance index by Doppler ultrasonography immediately after sepsis diagnosis
Time frame
Immediately after sepsis diagnosis (T0, baseline, first measurement)2
Renal resistance index (RRI)
Measurement of renal resistance index by Doppler ultrasonography after sepsis diagnosis
Time frame
24 hours after sepsis diagnosis (T24, second measurement)3
Renal resistance index (RRI)
Measurement of renal resistance index by Doppler ultrasonography after sepsis diagnosis
Time frame
48 hours after sepsis diagnosis (T48, third measurement)4
Urine [TIMP-2]•[IGFBP-7] biomarker
Measurement of \[TIMP-2\]•\[IGFBP-7\] in urine immediately after diagnosis of sepsis
Time frame
Immediately after diagnosis of sepsis (T0)Secondary outcomes
1
Time to onset of sepsis-associated acute kidney injury (SA-AKI)
Time from sepsis diagnosis to the development of SA-AKI.
Time frame
Up to 1 week after sepsis diagnosis2
Need for Renal Replacement Therapy (RRT) After Sepsis Diagnosis
Need for renal replacement therapy modality (continuous or intermittent) in patients diagnosed with sepsis during the follow-up period.
Time frame
Up to 1 week after sepsis diagnosis3
Length of ICU stay
Duration of stay in the intensive care unit recorded in days from ICU admission to ICU discharge.
Time frame
through study completion, an average of 1 year4
Length of hospital stay
Total duration of hospitalization recorded in days from hospital admission to hospital discharge.
Time frame
through study completion, an average of 1 yearLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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