Renal Angina Index for Predicting Acute Kidney Injury in Adult ICU Patients
ConditionAcute Kidney Injury
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIzmir Katip Celebi University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Renal Angina Index Assessment
Diagnostic testThe 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.
Treatment groups
324 Participants
are divided into 1 treatment groupGroup A: Eligible Adult ICU Patients1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Within 48 hours after RAI calculationSecondary outcomes
1
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
Time frame
Within 48 hours after RAI calculation2
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.
Time frame
Within 7 days after ICU admission3
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.
Time frame
Within 30 days after ICU admission4
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.
Time frame
From ICU admission through day 30Sponsors and contacts
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Source ClinicalTrials.gov
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