MULTIMODAL APPROACH IN THE DIAGNOSIS OF SEPTIC AKI (SEPTIC AKI)

March 13, 2026 updated by: Eda Macit Aydın, Ankara Etlik City Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
130

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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Eda Macit Aydın, M.D., M.D.
  • Phone Number: +90 312 797 00 00
  • Email: edamct@hotmail.com

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Doppler ultrasonography will measure RRI immediately after sepsis diagnosis (T0), at 24 hours (T24), and at 48 hours (T48).
Diagnostic test: Urinary TIMP-2 and IGFBP-7 biomarkers
Urine samples for [TIMP-2]*[IGFBP-7] biomarker measurement will be collected immediately after sepsis diagnosis (T0) and 24 hours later (T24).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Immediately after sepsis diagnosis (T0, baseline, first measurement)
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
24 hours after sepsis diagnosis (T24, second measurement)
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
48 hours after sepsis diagnosis (T48, third measurement)
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
Immediately after diagnosis of sepsis (T0)
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
24 hours after diagnosis of sepsis (T24)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to onset of sepsis-associated acute kidney injury (SA-AKI)
Time Frame: Up to 1 week after sepsis diagnosis
Time from sepsis diagnosis to the development of SA-AKI.
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
Need for renal replacement therapy modality (continuous or intermittent) in patients diagnosed with sepsis during the follow-up period.
Up to 1 week after sepsis diagnosis
Length of ICU stay
Time Frame: through study completion, an average of 1 year
Duration of stay in the intensive care unit recorded in days from ICU admission to ICU discharge.
through study completion, an average of 1 year
Length of hospital stay
Time Frame: through study completion, an average of 1 year
Total duration of hospitalization recorded in days from hospital admission to hospital discharge.
through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ankara Etlik City Hospital

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 30, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 7, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AEŞH-BADEK1-2026-025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

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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