Acute Kidney InjuryNCT07863505
Renal Angina Index for Predicting Acute Kidney Injury in Adult ICU Patients
An observational study of Acute Kidney Injury, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
Acute kidney injury (AKI) is a frequent complication of critical illness and is associated with increased morbidity and mortality. Early identification of patients at risk of progressing to moderate-to-severe AKI may facilitate closer monitoring and timely implementation of kidney-protective strategies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Renal Angina Index Assessment
- How many people
- 324 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2026to 30 Nov 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: Adult patients admitted to the participating adult intensive care unit will be considered for enrollment. Consecutive admissions meeting the eligibility criteria will be screened regardless of admission source or subsequently calculated Renal Angina Index category. The Renal Angina Index will be calculated 24 hours after ICU admission using routinely collected clinical and laboratory data.
Who may be able to join
- Age 18 years or older.
- Admission to the participating adult intensive care unit.
- Availability of serum creatinine measurements at ICU admission and 24 hours after ICU admission.
- Availability of a stable outpatient serum creatinine measurement obtained within the 6 months preceding ICU admission that can be used as the baseline value for KDIGO acute kidney injury staging.
- Availability of the clinical and laboratory data required to calculate the Renal Angina Index at 24 hours after ICU admission.
- Availability of serum creatinine and urine-output data required for assessment of the primary outcome during the 48 hours following Renal Angina Index calculation.
- Written informed consent from the participant or a legally authorized representative.
Who cannot join
- Age younger than 18 years.
- KDIGO stage 2 or stage 3 acute kidney injury present at ICU admission or developing before calculation of the Renal Angina Index at 24 hours after ICU admission.
- Initiation of acute renal replacement therapy before calculation of the Renal Angina Index.
- End-stage kidney disease requiring chronic renal replacement therapy.
- History of kidney transplantation.
- Absence of an eligible stable outpatient baseline serum creatinine measurement within the 6 months preceding ICU admission.
Show all 9Show fewer
- Death, discharge, or transfer from the ICU within the first 24 hours after admission, preventing calculation of the Renal Angina Index.
- Insufficient data for assessment of the primary outcome during the 48-hour period following Renal Angina Index calculation.
- Pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Izmir Katip Celebi University Ataturk Training and Research Hospital
Izmir, İzmir, 35360
Murat Aksun, M.D., +90 552 363 16 14, murataksun@yahoo.com
Dilara Dilan Fidan Menekşe, M.D., +90 545 636 76 80, dln.fidan@hotmail.com
About this study
Official title: Predictive Performance of the Renal Angina Index for Acute Kidney Injury in Adult Intensive Care Unit Patients: A Prospective Cohort Study
Acute kidney injury (AKI) is a frequent complication of critical illness and is associated with increased morbidity and mortality. Early identification of patients at risk of progressing to moderate-to-severe AKI may facilitate closer monitoring and timely implementation of kidney-protective strategies.
This prospective observational cohort study will evaluate the predictive performance of the Renal Angina Index (RAI) for the development of Kidney Disease: Improving Global Outcomes (KDIGO) stage 2 or stage 3 AKI in adult intensive care unit patients. Consecutive eligible patients admitted to the participating adult intensive care unit will be enrolled. The RAI will be calculated 24 hours after ICU admission using routinely available clinical characteristics and the change in serum creatinine between ICU admission and 24 hours.
Read more
The primary outcome will be the development of KDIGO stage 2 or stage 3 AKI during the subsequent 48 hours. AKI staging will incorporate serum creatinine, urine-output, and renal replacement therapy criteria according to KDIGO definitions. The predictive performance of RAI will be evaluated using receiver operating characteristic analysis and the prespecified RAI threshold of ≥10.
Secondary outcomes will include 7-day and 30-day intensive care unit mortality, intensive care unit length of stay, and duration of invasive mechanical ventilation.
Read the detailed description
This single-center, prospective, noninterventional cohort study will evaluate the predictive performance of the Renal Angina Index (RAI) for subsequent development of moderate-to-severe acute kidney injury in critically ill adults. Consecutive eligible patients admitted to the participating adult intensive care unit will be screened for enrollment irrespective of admission source or subsequently calculated RAI category. Clinical management will remain entirely under the responsibility of the treating team, and no treatment or diagnostic intervention will be assigned by the study protocol.
The RAI will be calculated 24 hours after ICU admission. The clinical-risk component will be determined using the highest applicable prespecified risk category at ICU admission, and the renal-injury component will be determined from the absolute change in serum creatinine between ICU admission and 24 hours. The resulting RAI ranges from 1 to 40, with RAI ≥10 representing the prespecified high-risk threshold. RAI <10 and RAI ≥10 will be evaluated as prespecified risk strata within a single observational cohort.
The primary outcome will be development of KDIGO stage 2 or stage 3 AKI during the 48 hours following RAI calculation. AKI severity will be classified using serum creatinine, urine-output, and acute renal replacement therapy criteria. Stage 2 AKI will be defined as serum creatinine 2.0-2.9 times baseline or urine output <0.5 mL/kg/hour for at least 12 hours. Stage 3 AKI will be defined as serum creatinine ≥3.0 times baseline, an increase in serum creatinine to ≥4.0 mg/dL in the setting of AKI, initiation of acute renal replacement therapy, urine output <0.3 mL/kg/hour for at least 24 hours, or anuria for at least 12 hours. The highest KDIGO stage reached by any applicable criterion will determine AKI severity. KDIGO Baseline serum creatinine for AKI staging will be defined as the most recent stable outpatient serum creatinine measurement obtained within the 6 months preceding ICU admission. Participants without an eligible baseline serum creatinine measurement will be excluded, and no alternative baseline creatinine estimation or imputation will be performed. The baseline serum creatinine used for KDIGO staging will be distinct from the ICU-admission serum creatinine used to calculate the RAI renal-injury component.
Serum creatinine measurements obtained during routine care at ICU admission and approximately 24, 48, and 72 hours after admission will be recorded. Urine output will be prospectively obtained from routine clinical documentation and evaluated according to KDIGO duration and weight-adjusted thresholds. Renal replacement therapy initiation and its indication will also be recorded. Participants who have already developed KDIGO stage 2 or stage 3 AKI at or before the 24-hour RAI assessment will not be included in the primary incident-AKI prediction analysis, because the target outcome will already have occurred before application of the index test.
Discrimination of the RAI for development of KDIGO stage 2-3 AKI will be evaluated using the area under the receiver operating characteristic curve with 95% confidence intervals. For the prespecified threshold of RAI ≥10, sensitivity, specificity, positive predictive value, negative predictive value, positive and negative likelihood ratios, and overall classification accuracy will be reported with 95% confidence intervals. An alternative threshold based on the Youden index will be considered exploratory.
Secondary clinical outcomes will include 7-day and 30-day intensive care unit mortality, intensive care unit length of stay, and duration of invasive mechanical ventilation.
- Conditions
- Acute Kidney Injury
- Being tested
- Renal Angina Index Assessment
- Keywords
- Renal Angina Index, Acute Kidney Injury, Intensive Care Unit, Critically Ill Adults, Kidney Injury Prediction, Risk Stratification
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal Angina Index AssessmentDiagnostic test
The Renal Angina Index will be calculated 24 hours after ICU admission using routinely available clinical and laboratory information. The RAI will be used as a prognostic index to evaluate the risk of subsequent KDIGO stage 2 or stage 3 acute kidney injury. No treatment, diagnostic procedure, or therapeutic intervention will be assigned on the basis of the RAI by the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Eligible Adult ICU Patients | A single prospective cohort of consecutive eligible adult patients admitted to the participating intensive care unit. The Renal Angina Index (RAI) will be calculated 24 hours after ICU admission using routinely collected clinical and laboratory data. Participants will subsequently be analyzed according to the prespecified RAI strata of <10 and ≥10. No treatment assignment will be made by the study protocol. Receives: Diagnostic Test: Renal Angina Index Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Receiver Operating Characteristic Curve of the Renal Angina Index for Predicting KDIGO Stage 2 or Stage 3 Acute Kidney Injury
The predictive discrimination of the Renal Angina Index (RAI), calculated 24 hours after intensive care unit admission, for the development of Kidney Disease: Improving Global Outcomes (KDIGO) stage 2 or stage 3 acute kidney injury (AKI) during the subsequent 48 hours will be assessed using the area under the receiver operating characteristic curve (AUROC), with a 95% confidence interval.
The target outcome will be development of KDIGO stage 2 or stage 3 AKI within 48 hours after RAI calculation. KDIGO stage 2 AKI will be defined as serum creatinine 2.0-2.9 times baseline or urine output <0.5 mL/kg/hour for at least 12 hours. KDIGO stage 3 AKI will be defined as serum creatinine ≥3.0 times baseline, serum creatinine ≥4.0 mg/dL in the setting of AKI, initiation of acute renal replacement therapy, urine output <0.3 mL/kg/hour for at least 24 hours, or anuria for at least 12 hours. When more than one criterion is met, the highest KDIGO stage reached will determine AKI severity.
Measured: Within 48 hours after RAI calculation
Secondary outcomes (5)
Development of KDIGO Stage 2 or Stage 3 Acute Kidney Injury Within 48 Hours After RAI Calculation
The number and proportion of participants who develop Kidney Disease: Improving Global Outcomes (KDIGO) stage 2 or stage 3 acute kidney injury (AKI) during the 48-hour period following calculation of the Renal Angina Index (RAI) will be recorded.
KDIGO stage 2 AKI will be defined by either of the following:
Serum creatinine 2.0-2.9 times the baseline value; or
Urine output <0.5 mL/kg/hour for at least 12 hours.
KDIGO stage 3 AKI will be defined by any of the following:
Serum creatinine ≥3.0 times the baseline value;
Serum creatinine ≥4.0 mg/dL in the setting of acute kidney injury;
Initiation of acute renal replacement therapy;
Urine output <0.3 mL/kg/hour for at least 24 hours; or
Anuria for at least 12 hours.
If serum creatinine and urine-output criteria correspond to different KDIGO stages, the highest stage reached will determine AKI severity.
Baseline serum creatinine will be defined as the most recent stable outpatient serum creatinine measurement obtained within the
Measured: Within 48 hours after RAI calculation
7-Day Intensive Care Unit Mortality
The number and proportion of participants who die in the intensive care unit within 7 days after ICU admission will be recorded. Deaths occurring after live discharge or transfer from the ICU will not be classified as ICU deaths.
Measured: Within 7 days after ICU admission
30-Day Intensive Care Unit Mortality
The number and proportion of participants who die in the intensive care unit within 30 days after ICU admission will be recorded. Deaths occurring after live discharge or transfer from the ICU will not be classified as ICU deaths.
Measured: Within 30 days after ICU admission
Intensive Care Unit-Free Days Through Day 30
The number of days alive and free from the intensive care unit (ICU) during the first 30 days after ICU admission will be calculated. Participants who die before day 30 will be assigned 0 ICU-free days. Participants who remain in the ICU through day 30 will also be assigned 0 ICU-free days. For participants discharged alive from the ICU before day 30, ICU-free days will be calculated as the number of days alive and outside the ICU through day 30. Any subsequent ICU readmission during this period will not be counted as ICU-free time. Higher values indicate a more favorable outcome.
Measured: From ICU admission through day 30
Ventilator-Free Days Through Day 30
Ventilator-free days will be defined as the number of days during the first 28 days after ICU admission that the participant is alive and free from invasive mechanical ventilation delivered through an endotracheal tube or tracheostomy. Participants who die before day 28 will be assigned 0 ventilator-free days. Participants who remain invasively mechanically ventilated through day 28 will also be assigned 0 ventilator-free days. For participants successfully liberated from invasive mechanical ventilation before day 28, ventilator-free days will be counted from successful liberation through day 28. If invasive mechanical ventilation is restarted, the intervening period will not be considered definitive ventilator-free time until final successful liberation. Participants who never receive invasive mechanical ventilation will have 28 ventilator-free days. Noninvasive ventilation and high-flow nasal oxygen will not be considered invasive mechanical ventilation for this outcome.
Measured: From ICU admission through day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion30 Nov 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.
- 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
- 324 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Salih Tüzen, MD, Izmir Katip Celebi University
- Investigators
- Senem Girgin, M.D., Principal investigator, Izmir Katip Celebi University Atatürk Training and Research HospitalMurat Aksun, M.D., Study director, Izmir Katip Celebi University Atatürk Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07863505
- Sponsor's protocol ID
- 2026-SAEK-0459
- Status last verified
- Oct 2026
- First submitted
- 2 Oct 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified individual participant data underlying the results reported from this study may be shared with qualified researchers upon reasonable request. Shared data may include demographic, clinical, laboratory, Renal Angina Index, acute kidney injury outcome, and prespecified secondary outcome variables necessary to reproduce the published analyses. Data sharing will be subject to approval by the principal investigator and the relevant institutional and ethical requirements. No directly identifiable participant information will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Performance of the Renal Angina Index for Acute Kidney Injury in Adult Intensive Care Unit Patients: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07863505
- Acronym / sponsor ID
- 2026-SAEK-0459
- Conditions
- Acute Kidney Injury
- Keywords
- Renal Angina Index, Acute Kidney Injury, Intensive Care Unit, Critically Ill Adults, Kidney Injury Prediction, Risk Stratification
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 324 participants (estimated)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 7 Oct 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.
Acute kidney injury (AKI) is a frequent complication of critical illness and is associated with increased morbidity and mortality. Early identification of patients at risk of progressing to moderate-to-severe AKI may facilitate closer monitoring and timely implementation of kidney-protective strategies.
This prospective observational cohort study will evaluate the predictive performance of the Renal Angina Index (RAI) for the development of Kidney Disease: Improving Global Outcomes (KDIGO) stage 2 or stage 3 AKI in adult intensive care unit patients. Consecutive eligible patients admitted to the participating adult intensive care unit will be enrolled. The RAI will be calculated 24 hours after ICU admission using routinely available clinical characteristics and the change in serum creatinine between ICU admission and 24 hours.
The primary outcome will be the development of KDIGO stage 2 or stage 3 AKI during the subsequent 48 hours. AKI staging will incorporate serum creatinine, urine-output, and renal replacement therapy criteria according to KDIGO definitions. The predictive performance of RAI will be evaluated using receiver operating characteristic analysis and the prespecified RAI threshold of ≥10.
Secondary outcomes will include 7-day and 30-day intensive care unit mortality, intensive care unit length of stay, and duration of invasive mechanical ventilation.
Detailed description
This single-center, prospective, noninterventional cohort study will evaluate the predictive performance of the Renal Angina Index (RAI) for subsequent development of moderate-to-severe acute kidney injury in critically ill adults. Consecutive eligible patients admitted to the participating adult intensive care unit will be screened for enrollment irrespective of admission source or subsequently calculated RAI category. Clinical management will remain entirely under the responsibility of the treating team, and no treatment or diagnostic intervention will be assigned by the study protocol.
The RAI will be calculated 24 hours after ICU admission. The clinical-risk component will be determined using the highest applicable prespecified risk category at ICU admission, and the renal-injury component will be determined from the absolute change in serum creatinine between ICU admission and 24 hours. The resulting RAI ranges from 1 to 40, with RAI ≥10 representing the prespecified high-risk threshold. RAI <10 and RAI ≥10 will be evaluated as prespecified risk strata within a single observational cohort.
The primary outcome will be development of KDIGO stage 2 or stage 3 AKI during the 48 hours following RAI calculation. AKI severity will be classified using serum creatinine, urine-output, and acute renal replacement therapy criteria. Stage 2 AKI will be defined as serum creatinine 2.0-2.9 times baseline or urine output <0.5 mL/kg/hour for at least 12 hours. Stage 3 AKI will be defined as serum creatinine ≥3.0 times baseline, an increase in serum creatinine to ≥4.0 mg/dL in the setting of AKI, initiation of acute renal replacement therapy, urine output <0.3 mL/kg/hour for at least 24 hours, or anuria for at least 12 hours. The highest KDIGO stage reached by any applicable criterion will determine AKI severity. KDIGO Baseline serum creatinine for AKI staging will be defined as the most recent stable outpatient serum creatinine measurement obtained within the 6 months preceding ICU admission. Participants without an eligible baseline serum creatinine measurement will be excluded, and no alternative baseline creatinine estimation or imputation will be performed. The baseline serum creatinine used for KDIGO staging will be distinct from the ICU-admission serum creatinine used to calculate the RAI renal-injury component.
Serum creatinine measurements obtained during routine care at ICU admission and approximately 24, 48, and 72 hours after admission will be recorded. Urine output will be prospectively obtained from routine clinical documentation and evaluated according to KDIGO duration and weight-adjusted thresholds. Renal replacement therapy initiation and its indication will also be recorded. Participants who have already developed KDIGO stage 2 or stage 3 AKI at or before the 24-hour RAI assessment will not be included in the primary incident-AKI prediction analysis, because the target outcome will already have occurred before application of the index test.
Discrimination of the RAI for development of KDIGO stage 2-3 AKI will be evaluated using the area under the receiver operating characteristic curve with 95% confidence intervals. For the prespecified threshold of RAI ≥10, sensitivity, specificity, positive predictive value, negative predictive value, positive and negative likelihood ratios, and overall classification accuracy will be reported with 95% confidence intervals. An alternative threshold based on the Youden index will be considered exploratory.
Secondary clinical outcomes will include 7-day and 30-day intensive care unit mortality, intensive care unit length of stay, and duration of invasive mechanical ventilation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eligible Adult ICU Patients | – | Diagnostic Test: Renal Angina Index AssessmentA single prospective cohort of consecutive eligible adult patients admitted to the participating intensive care unit. The Renal Angina Index (RAI) will be calculated 24 hours after ICU admission using routinely collected clinical and laboratory data. Participants will subsequently be analyzed according to the prespecified RAI strata of <10 and ≥10. No treatment assignment will be made by the study protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to the participating adult intensive care unit will be considered for enrollment. Consecutive admissions meeting the eligibility criteria will be screened regardless of admission source or subsequently calculated Renal Angina Index category. The Renal Angina Index will be calculated 24 hours after ICU admission using routinely collected clinical and laboratory data.
Key inclusion criteria (7 listed)
- Age 18 years or older.
- Admission to the participating adult intensive care unit.
- Availability of serum creatinine measurements at ICU admission and 24 hours after ICU admission.
- Availability of a stable outpatient serum creatinine measurement obtained within the 6 months preceding ICU admission that can be used as the baseline value for KDIGO acute kidney injury staging.
- Availability of the clinical and laboratory data required to calculate the Renal Angina Index at 24 hours after ICU admission.
Key exclusion criteria (9 listed)
- Age younger than 18 years.
- KDIGO stage 2 or stage 3 acute kidney injury present at ICU admission or developing before calculation of the Renal Angina Index at 24 hours after ICU admission.
- Initiation of acute renal replacement therapy before calculation of the Renal Angina Index.
- End-stage kidney disease requiring chronic renal replacement therapy.
- History of kidney transplantation.
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 Angina Index AssessmentThe Renal Angina Index will be calculated 24 hours after ICU admission using routinely available clinical and laboratory information. The RAI will be used as a prognostic index to evaluate the risk of subsequent KDIGO stage 2 or stage 3 acute kidney injury. No treatment, diagnostic procedure, or therapeutic intervention will be assigned on the basis of the RAI by the study protocol. | Diagnostic test | Eligible Adult ICU Patients |
Primary outcome
Area Under the Receiver Operating Characteristic Curve of the Renal Angina Index for Predicting KDIGO Stage 2 or Stage 3 Acute Kidney Injury
Time frame: Within 48 hours after RAI calculation
The predictive discrimination of the Renal Angina Index (RAI), calculated 24 hours after intensive care unit admission, for the development of Kidney Disease: Improving Global Outcomes (KDIGO) stage 2 or stage 3 acute kidney injury (AKI) during the subsequent 48 hours will be assessed using the area under the receiver operating characteristic curve (AUROC), with a 95% confidence interval. The target outcome will be development of KDIGO stage 2 or stage 3 AKI within 48 hours after RAI calculation. KDIGO stage 2 AKI will be defined as serum creatinine 2.0-2.9 times baseline or urine output <0.5 mL/kg/hour for at least 12 hours. KDIGO stage 3 AKI will be defined as serum creatinine ≥3.0 times baseline, serum creatinine ≥4.0 mg/dL in the setting of AKI, initiation of acute renal replacement therapy, urine output <0.3 mL/kg/hour for at least 24 hours, or anuria for at least 12 hours. When more than one criterion is met, the highest KDIGO stage reached will determine AKI severity.
5 secondary outcomes
Development of KDIGO Stage 2 or Stage 3 Acute Kidney Injury Within 48 Hours After RAI Calculation
Time frame: Within 48 hours after RAI calculation
7-Day Intensive Care Unit Mortality
Time frame: Within 7 days after ICU admission
30-Day Intensive Care Unit Mortality
Time frame: Within 30 days after ICU admission
Intensive Care Unit-Free Days Through Day 30
Time frame: From ICU admission through day 30
Ventilator-Free Days Through Day 30
Time frame: From ICU admission through day 30
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 7 Oct 2026.
- Individual participant dataSharing planned: Undecided. De-identified individual participant data underlying the results reported from this study may be shared with qualified researchers upon reasonable request. Shared data may include demographic, clinical, laboratory, Renal Angina Index, acute kidney injury outcome, and prespecified secondary outcome variables necessary to reproduce the published analyses. Data sharing will be subject to approval by the principal investigator and the relevant institutional and ethical requirements. No directly identifiable participant information will be shared.
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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.
Senem Girgin, M.D. principal investigator
Izmir Katip Celebi University Atatürk Training and Research Hospital
Murat Aksun, M.D. study director
Izmir Katip Celebi University Atatürk Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
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 7 inclusion and 9 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 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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 Dilara Dilan Fidan Menekşe, M.D. (+90 545 636 76 80, dln.fidan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Receiver Operating Characteristic Curve of the Renal Angina Index for Predicting KDIGO Stage 2 or Stage 3 Acute Kidney Injury (time frame: Within 48 hours after RAI calculation). 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 7 Oct 2026.