Acute Kidney InjurySEPTIC AKINCT07472452
MULTIMODAL APPROACH IN THE DIAGNOSIS OF SEPTIC AKI
An observational study of Acute Kidney Injury and Sepsis, run by Ankara Etlik City Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Sepsis, Critical Illness
- What is being tested?
- Renal Resistive Index (RRI) Doppler Ultrasound and Urinary TIMP-2 and IGFBP-7 biomarkers
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2026to 30 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adults ≥18 years
- Diagnosis of sepsis (per Sepsis-3 clinical criteria)
- RRI measurement feasible at bedside
- Informed consent from participant or legally authorized representative
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A MULTIMODAL APPROACH TO PREDICTING SEPSIS-RELATED ACUTE RENAL INJURY: A PROSPECTIVE COHORT STUDY
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.
Read the detailed description
Purpose and Rationale:
Sepsis is a life-threatening condition caused by a dysregulated host response to infection and remains a major cause of morbidity and mortality in intensive care units. Acute kidney injury (AKI) is one of the most frequent complications of sepsis and is associated with prolonged ICU and hospital stay, increased healthcare costs, and higher mortality. Early detection of renal dysfunction in septic patients is therefore crucial to improve clinical outcomes.
The diagnosis of AKI in clinical practice is mainly based on changes in serum creatinine and urine output according to KDIGO (Kidney Disease: Improving Global Outcomes) criteria. However, serum creatinine reflects functional loss of the kidney and may increase only after significant renal injury has already occurred, which may delay the diagnosis of AKI.
Recently, several physiological and biochemical markers have been investigated for earlier detection of AKI. The renal resistive index (RRI), obtained by Doppler ultrasonography of intrarenal arteries, reflects renal vascular resistance and changes in renal hemodynamics. Previous studies suggest that RRI may increase before conventional markers of kidney injury become abnormal and may help identify patients at risk of AKI during the early phase of critical illness.
In addition, urinary biomarkers reflecting tubular cellular stress have been proposed as early indicators of kidney injury. Tissue inhibitor of metalloproteinases-2 (TIMP-2) and insulin-like growth factor binding protein-7 (IGFBP-7) are released by renal tubular epithelial cells during cellular stress and cell cycle arrest. The combined urinary biomarker product [TIMP-2]•[IGFBP-7] has been shown to identify patients at risk for AKI before increases in serum creatinine occur.
This observational study aims to evaluate changes in renal resistive index and urinary biomarkers ([TIMP-2]*[IGFBP-7]) in patients with sepsis and to investigate their potential role in the early detection of sepsis-associated acute kidney injury.
Design:
Prospective, single-center, observational cohort study with consecutive patient enrollment over an estimated period of approximately 12-month period (or until the target sample size is reached) following ethics committee approval and study registration. Anticipated sample: 120-130 (It has been increased to prevent potential data loss.)
Participants - Eligibility:
Inclusion: Patients receiving treatment in intensive care, ≥18 years of age, diagnosed with sepsis, able to undergo RRI, and who have obtained informed consent from their legally authorized representative (or the patient).
Exclusion: End-stage renal disease (chronic RRT or eGFR <15 ml/min/1.73 m²), kidney transplant, renal artery stenosis, technical/anatomical contraindications to RRI, poor echogenicity (for RRI imaging), pregnancy.
Procedures and Timing:
Renal resistance index (RRI) will be measured by Doppler ultrasonography immediately after sepsis diagnosis (T0, baseline, first measurement), 24 hours later (T24, second measurement), and 48 hours later (T48, third measurement). RRI measurements will be taken from the interlobar arteries of both kidneys, and at least three RRI Doppler waveforms will be recorded for each kidney.
Urinary biomarker levels of [TIMP-2]•[IGFBP-7] will be measured immediately after the diagnosis of sepsis (T0) and at 24 hours after sepsis diagnosis (T24).
Renal function tests and electrolyte levels will be recorded at the time of admission to the intensive care unit (T0), and 24 hours (T24), 48 hours (T48), and 72 hours (T72) after sepsis diagnosis (every 24 hours for 72 hours).
Outcomes:
Primary: Whether sepsis-related acute renal failure (SA-AKI) develops in patients diagnosed with sepsis, and the effect of RRI and urinary [TIMP-2]•[IGFBP-7] biomarkers in predicting the development of SA-AKI.
Secondary: need for RRT up to 1 week after sepsis diagnosis, SA-AKI onset timing, ICU length of stay, and hospital length of stay.
Analysis:
Descriptives and appropriate group comparisons (AKI+ vs AKI-).
Primary model: Logistic regression → AKI (yes/no) ~ RRI_T0 (continuous and prespecified ≥0.70 threshold) + [TIMP-2]·[IGFBP-7] + covariates (age, eGFR, SOFA, vasopressors, nephrotoxins/contrast, fluid balance).
Safety and Privacy:
Ultrasound and urine sampling are not risky; the study does not direct clinical treatment.
- Conditions
- Acute Kidney Injury, Sepsis, Critical Illness, Renal Resistive Index
- Being tested
- Renal Resistive Index (RRI) Doppler Ultrasound, Urinary TIMP-2 and IGFBP-7 biomarkers
- Keywords
- Renal Resistive Index (RRI), Cell Cycle Arrest Biomarkers, Intensive Care Units, Sepsis, Sepsis-Associated AKI
- Medical subject headings
- Acute Kidney Injury, Sepsis, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal Resistive Index (RRI) Doppler UltrasoundDiagnostic test
Doppler ultrasonography will measure RRI immediately after sepsis diagnosis (T0), at 24 hours (T24), and at 48 hours (T48).
Urinary TIMP-2 and IGFBP-7 biomarkersDiagnostic test
Urine samples for [TIMP-2]*[IGFBP-7] biomarker measurement will be collected immediately after sepsis diagnosis (T0) and 24 hours later (T24).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Renal Resistive Index (RRI) Doppler Ultrasound; Diagnostic Test: Urinary TIMP-2 and IGFBP-7 biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal resistance index (RRI)
Measurement of renal resistance index by Doppler ultrasonography immediately after sepsis diagnosis
Measured: Immediately after sepsis diagnosis (T0, baseline, first measurement)
Renal resistance index (RRI)
Measurement of renal resistance index by Doppler ultrasonography after sepsis diagnosis
Measured: 24 hours after sepsis diagnosis (T24, second measurement)
Renal resistance index (RRI)
Measurement of renal resistance index by Doppler ultrasonography after sepsis diagnosis
Measured: 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
Measured: Immediately after diagnosis of sepsis (T0)
Urine [TIMP-2]•[IGFBP-7] biomarker
Measurement of [TIMP-2]•[IGFBP-7] in urine after sepsis diagnosis
Measured: 24 hours after diagnosis of sepsis (T24)
Secondary outcomes (4)
Time to onset of sepsis-associated acute kidney injury (SA-AKI)
Time from sepsis diagnosis to the development of SA-AKI.
Measured: Up to 1 week after sepsis diagnosis
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.
Measured: Up to 1 week after sepsis diagnosis
Length of ICU stay
Duration of stay in the intensive care unit recorded in days from ICU admission to ICU discharge.
Measured: through study completion, an average of 1 year
Length of hospital stay
Total duration of hospitalization recorded in days from hospital admission to hospital discharge.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start30 Mar 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Eda Macit Aydın, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07472452
- Sponsor's protocol ID
- AEŞH-BADEK1-2026-025
- Acronym
- SEPTIC AKI
- Status last verified
- Mar 2026
- First submitted
- 7 Feb 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared due to patient privacy considerations and institutional ethics committee regulations. De-identified data may be available from the corresponding investigator upon reasonable request and with approval from the ethics committee.
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A MULTIMODAL APPROACH TO PREDICTING SEPSIS-RELATED ACUTE RENAL INJURY: A PROSPECTIVE COHORT STUDY
- ClinicalTrials.gov ID
- NCT07472452
- Acronym / sponsor ID
- SEPTIC AKI / AEŞH-BADEK1-2026-025
- 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
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 30 Mar 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Purpose and Rationale:
Sepsis is a life-threatening condition caused by a dysregulated host response to infection and remains a major cause of morbidity and mortality in intensive care units. Acute kidney injury (AKI) is one of the most frequent complications of sepsis and is associated with prolonged ICU and hospital stay, increased healthcare costs, and higher mortality. Early detection of renal dysfunction in septic patients is therefore crucial to improve clinical outcomes.
The diagnosis of AKI in clinical practice is mainly based on changes in serum creatinine and urine output according to KDIGO (Kidney Disease: Improving Global Outcomes) criteria. However, serum creatinine reflects functional loss of the kidney and may increase only after significant renal injury has already occurred, which may delay the diagnosis of AKI.
Recently, several physiological and biochemical markers have been investigated for earlier detection of AKI. The renal resistive index (RRI), obtained by Doppler ultrasonography of intrarenal arteries, reflects renal vascular resistance and changes in renal hemodynamics. Previous studies suggest that RRI may increase before conventional markers of kidney injury become abnormal and may help identify patients at risk of AKI during the early phase of critical illness.
In addition, urinary biomarkers reflecting tubular cellular stress have been proposed as early indicators of kidney injury. Tissue inhibitor of metalloproteinases-2 (TIMP-2) and insulin-like growth factor binding protein-7 (IGFBP-7) are released by renal tubular epithelial cells during cellular stress and cell cycle arrest. The combined urinary biomarker product [TIMP-2]•[IGFBP-7] has been shown to identify patients at risk for AKI before increases in serum creatinine occur.
This observational study aims to evaluate changes in renal resistive index and urinary biomarkers ([TIMP-2]*[IGFBP-7]) in patients with sepsis and to investigate their potential role in the early detection of sepsis-associated acute kidney injury.
Design:
Prospective, single-center, observational cohort study with consecutive patient enrollment over an estimated period of approximately 12-month period (or until the target sample size is reached) following ethics committee approval and study registration. Anticipated sample: 120-130 (It has been increased to prevent potential data loss.)
Participants - Eligibility:
Inclusion: Patients receiving treatment in intensive care, ≥18 years of age, diagnosed with sepsis, able to undergo RRI, and who have obtained informed consent from their legally authorized representative (or the patient).
Exclusion: End-stage renal disease (chronic RRT or eGFR <15 ml/min/1.73 m²), kidney transplant, renal artery stenosis, technical/anatomical contraindications to RRI, poor echogenicity (for RRI imaging), pregnancy.
Procedures and Timing:
Renal resistance index (RRI) will be measured by Doppler ultrasonography immediately after sepsis diagnosis (T0, baseline, first measurement), 24 hours later (T24, second measurement), and 48 hours later (T48, third measurement). RRI measurements will be taken from the interlobar arteries of both kidneys, and at least three RRI Doppler waveforms will be recorded for each kidney.
Urinary biomarker levels of [TIMP-2]•[IGFBP-7] will be measured immediately after the diagnosis of sepsis (T0) and at 24 hours after sepsis diagnosis (T24).
Renal function tests and electrolyte levels will be recorded at the time of admission to the intensive care unit (T0), and 24 hours (T24), 48 hours (T48), and 72 hours (T72) after sepsis diagnosis (every 24 hours for 72 hours).
Outcomes:
Primary: Whether sepsis-related acute renal failure (SA-AKI) develops in patients diagnosed with sepsis, and the effect of RRI and urinary [TIMP-2]•[IGFBP-7] biomarkers in predicting the development of SA-AKI.
Secondary: need for RRT up to 1 week after sepsis diagnosis, SA-AKI onset timing, ICU length of stay, and hospital length of stay.
Analysis:
Descriptives and appropriate group comparisons (AKI+ vs AKI-).
Primary model: Logistic regression → AKI (yes/no) ~ RRI_T0 (continuous and prespecified ≥0.70 threshold) + [TIMP-2]·[IGFBP-7] + covariates (age, eGFR, SOFA, vasopressors, nephrotoxins/contrast, fluid balance).
Safety and Privacy:
Ultrasound and urine sampling are not risky; the study does not direct clinical treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sepsis ICU Cohort | – | Diagnostic Test: Renal Resistive Index (RRI) Doppler Ultrasound, Diagnostic Test: Urinary TIMP-2 and IGFBP-7 biomarkersAdult 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Adults ≥18 years
- Diagnosis of sepsis (per Sepsis-3 clinical criteria)
- RRI measurement feasible at bedside
- Informed consent from participant or legally authorized representative
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Renal Resistive Index (RRI) Doppler UltrasoundDoppler ultrasonography will measure RRI immediately after sepsis diagnosis (T0), at 24 hours (T24), and at 48 hours (T48). | Diagnostic test | Sepsis ICU Cohort |
| Urinary TIMP-2 and IGFBP-7 biomarkersUrine samples for [TIMP-2]*[IGFBP-7] biomarker measurement will be collected immediately after sepsis diagnosis (T0) and 24 hours later (T24). | Diagnostic test | Sepsis ICU Cohort |
Primary outcome
Renal resistance index (RRI)
Time frame: Immediately after sepsis diagnosis (T0, baseline, first measurement)
Measurement of renal resistance index by Doppler ultrasonography immediately after sepsis diagnosis
Renal resistance index (RRI)
Time frame: 24 hours after sepsis diagnosis (T24, second measurement)
Measurement of renal resistance index by Doppler ultrasonography after sepsis diagnosis
Renal resistance index (RRI)
Time frame: 48 hours after sepsis diagnosis (T48, third measurement)
Measurement of renal resistance index by Doppler ultrasonography after sepsis diagnosis
Urine [TIMP-2]•[IGFBP-7] biomarker
Time frame: Immediately after diagnosis of sepsis (T0)
Measurement of [TIMP-2]•[IGFBP-7] in urine immediately after diagnosis of sepsis
Urine [TIMP-2]•[IGFBP-7] biomarker
Time frame: 24 hours after diagnosis of sepsis (T24)
Measurement of [TIMP-2]•[IGFBP-7] in urine after sepsis diagnosis
4 secondary outcomes
Time to onset of sepsis-associated acute kidney injury (SA-AKI)
Time frame: Up to 1 week after sepsis diagnosis
Need for Renal Replacement Therapy (RRT) After Sepsis Diagnosis
Time frame: Up to 1 week after sepsis diagnosis
Length of ICU stay
Time frame: through study completion, an average of 1 year
Length of hospital stay
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared due to patient privacy considerations and institutional ethics committee regulations. De-identified data may be available from the corresponding investigator upon reasonable request and with approval from the ethics committee.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and Sepsis, run by Ankara Etlik City Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eda Macit Aydın, M.D., M.D. (+90 312 797 00 00, edamct@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal resistance index (RRI) (time frame: Immediately after sepsis diagnosis (T0, baseline, first measurement)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.