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Starting soon Observational

Renal Angina Index for Predicting Acute Kidney Injury in Adult ICU Patients

NCT07863505 · tracked via the Priya Life Science Turkey tracker
Phase
Observational
Started
2026-11-01
Last updated
2026-10-07

Condition(s) studied

Acute Kidney Injury

Investigational drug(s) / intervention(s)

Renal Angina Index Assessment

Renal Angina Index Assessment: 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 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.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.

Primary outcome measure(s)

  • Area Under the Receiver Operating Characteristic Curve of the Renal Angina Index for Predicting KDIGO Stage 2 or Stage 3 Acute Kidney Injury — 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.

Trial sites (1)

FacilityCityRegionStatus
Izmir Katip Celebi University Ataturk Training and Research Hospital Izmir İzmir
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07863505 on ClinicalTrials.gov ↗ ← All trials in Turkey