Clinical trial NCT06791304: Renal Resistive Index in Early Detection of Postoperative Acute Kidney Injury
Official title: Effectiveness of Doppler Renal Resistive Index in Early Detection of Postoperative Acute Kidney Injury in Prolonged Cardiopulmonary Bypass Cardiac Surgeries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Insufficiency, Acute
Cardiac Surgery Associated - Acute Kidney Injury
Keywords: acute kidney injury
early detection
renal artery
doppler ultrasonography
cardiopulmonary bypass
Lead sponsor: Bursa Yüksek İhtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2025-01-24
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing open heart surgery with cardiopulmonary bypass under general anesthesia

Brief summary: The primary aim of our study was to investigate the role of renal doppler ultrasonography (USG) and preoperative/postoperative renal resistive index (RRI) in the early prediction of AKI. Our secondary aim is to evaluate perioperative parameters that may cause AKI, to determine the duration of intensive care unit (ICU)/hospitalization and 30-day mortality.

Detailed description: Our prospective, observational, cross-sectional study included patients with elective cardiac surgery under general anesthesia with prolonged CRP (\>70 min) and aortic cross-clamp (ACC) (\>60 min), \>18 years of age, without preoperative acute/chronic renal failure, and with preoperative/postoperative RRI measurements. Demographic data, comorbidities, medications, preoperative ejection fraction, admission hematocrit (HCT) and baseline serum creatinine (sCr), type of operation, and preoperative RRI were recorded. Intraoperative operation and CPB/ACC duration, blood product transfusion, urine output, amount of bleeding, fluid balance, use of vasopressor/inotropic agents and diuretics, and complications were recorded. RRI was measured by the same radiologist in the first postoperative hour. Urine output and fluid balance, vasopressor/inotropic agent requirement, diuretic use, sKr, HCT level and blood product transfusion were recorded for 3 days postoperatively. According to KDIGO guidelines, patients who did not develop CCI-AKI were divided into 2 groups as Group 1 (n:64) and patients who developed CCI-AKI were divided into Group 2 (n:26). In Group 2, renal failure stage, duration (acute/chronic) and RRT were recorded. ICU and hospital length of stay, postoperative complications and 30-day mortality were recorded.

Eligibility criteria: Inclusion Criteria:

* Elective cardiac surgeries under general anesthesia with prolonged CPB (\>70 min) and aortic cross clemp (\>60 min) time
* \>18 years of age, without preoperative acute or chronic renal failure
* with preoperative and postoperative RRI measurements

Exclusion Criteria:

* Patients with known renal insufficiency,
* Patients with acute renal failure in the last 3 months
* Emergency surgeries,
* Patients with arrhythmia end-stage renal disease and renal transplant
* Patients Patients with short duration of CPB (\<70 min) and ACK (\<60 min)
* Failed Doppler ultrasonography imaging

Primary outcomes:
measure: Comparison of preoperative, postoperative renal resistive index [median (min-max)]
timeFrame: Cases between September 2022 and January 2024
measure: Preoperative-postoperative percentage change of RRI (∆RRI) between two groups
timeFrame: Cases between September 2022 and January 2024
measure: Postoperative RRI ROC analysis
timeFrame: Cases between September 2022 and January 2024
measure: Postoperative grouping of patients according to KDIGO criteria
timeFrame: Cases between September 2022 and January 2024
Secondary outcomes:
measure: Hematocrit Change over Time [median (min-max)]
timeFrame: Cases between September 2022 and January 2024
measure: Distribution of Intraoperative Urine Output (mL) [median (min-max)]
timeFrame: Cases between September 2022 and January 2024
measure: Distribution of Intraoperative Administered Fluids (mL) [median (min-max)]
timeFrame: Cases between September 2022 and January 2024
measure: Distribution of Intraoperative Fluid Balance (mL) Between Groups [median (min-max)]
timeFrame: Cases between September 2022 and January 2024
measure: Comparison of Urine Output in the First 3 Postoperative Days Between and Within Groups [mean ± SD]
timeFrame: Cases between September 2022 and January 2024
measure: Comparison of Fluid Balance in the First 3 Postoperative Days Between and Within Groups[mean ± SD]
timeFrame: Cases between September 2022 and January 2024
measure: Intergroup and Intragroup Comparison of Postoperative First 3 Days sKr Values [median (min-max)]
timeFrame: Cases between September 2022 and January 2024
measure: Comparison of Postoperative Duration of ICU Stay, Duration of Hospitalization Between Groups (day) [median (min-max)]
timeFrame: Cases between September 2022 and January 2024
measure: Comparison of duration of postoperative mechanical ventilation (hour) [median (min-max)]
timeFrame: Cases between September 2022 and January 2024
measure: Comparison of Postoperative prolonged mechanical ventilation (>6 hours) Between Groups [median (min-max)]
timeFrame: Cases between September 2022 and January 2024
measure: Comparison of Postoperative 1-month mortality rate Between Groups [median (min-max)]
timeFrame: Cases between September 2022 and January 2024
measure: Postoperative Blood and Blood Products Transfusion, n (percent)
timeFrame: Cases between September 2022 and January 2024
measure: KDIGO Stages in Patients with Renal Failure, n (percent)
timeFrame: Cases between September 2022 and January 2024
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa High Specialization Training and Research Hospital
Study officials:
References:
citation: Bossard G, Bourgoin P, Corbeau JJ, Huntzinger J, Beydon L. Early detection of postoperative acute kidney injury by Doppler renal resistive index in cardiac surgery with cardiopulmonary bypass. Br J Anaesth. 2011 Dec;107(6):891-8. doi: 10.1093/bja/aer289. Epub 2011 Sep 22.
citation: Karim HM, Yunus M, Saikia MK, Kalita JP, Mandal M. Incidence and progression of cardiac surgery-associated acute kidney injury and its relationship with bypass and cross clamp time. Ann Card Anaesth. 2017 Jan-Mar;20(1):22-27. doi: 10.4103/0971-9784.197823.