Renal Resistive Index in Early Detection of Postoperative Acute Kidney Injury

NCT06791304 | Completed

• 1 other identifier: 2011-KAEK-25 2022/08-16
• Study Type: observational
• Target: 143
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Insufficiency, Acute; Cardiac Surgery Associated - Acute Kidney Injury

Keywords

acute kidney injury; early detection; renal artery; doppler ultrasonography; cardiopulmonary bypass

Outcome Measures

Primary Outcomes (4)

• Comparison of preoperative, postoperative renal resistive index [median (min-max)]

  The study aims to evaluate preoperative and postoperative renal resistive index (RRI) values between two groups. The renal resistive index (RRI) is a measure of renal vascular resistance obtained via Doppler ultrasound. . RRI values of 0.7 or higher are associated with worse renal outcomes, as they indicate increased vascular resistance. Statistical analyses will be performed to compare preoperative and postoperative RRI values between the groups.

  Cases between September 2022 and January 2024

• Preoperative-postoperative percentage change of RRI (∆RRI) between two groups

  The study aims to evaluate percentage change RRI (∆RRI) between two groups. Statistical analyses will be performed to compare magnitude of change in ∆RRI, between the groups.

  Cases between September 2022 and January 2024

• Postoperative RRI ROC analysis

  The study aims to assess the utility of postoperative renal resistive index (RRI) in predicting the development of cardiac surgery-associated acute kidney injury (CSA-AKI). Receiver operating characteristic (ROC) analysis will be employed to determine the discriminatory power of postoperative RRI and identify an optimal cut-off value for predicting CSA-AKI. Sensitivity, specificity, and predictive probabilities associated with the cut-off value will be evaluated.

  Cases between September 2022 and January 2024

• Postoperative grouping of patients according to KDIGO criteria

  The study plans to include 90 patients, categorized into two groups based on the KDIGO criteria for acute kidney injury (AKI): patients who do not develop cardiac surgery-associated AKI (CSA-AKI) and patients who do develop CSA-AKI. To analyze differences between the groups, specific clinical and biochemical parameters will be assessed and reported as separate outcome measures. These parameters will include \[specific measurements, e.g., serum creatinine levels (mg/dL), estimated glomerular filtration rate (eGFR, mL/min/1.73m²), and urine output (mL/kg/hour)\]. Each parameter will be assessed using standard laboratory or clinical methods, with units of measurement specified for each outcome. If multiple measurements are aggregated to generate a single outcome (e.g., BMI calculated from weight and height), this will be clearly described in the analysis.

  Cases between September 2022 and January 2024

Secondary Outcomes (13)

• Hematocrit Change over Time [median (min-max)]

  Cases between September 2022 and January 2024

• Distribution of Intraoperative Urine Output (mL) [median (min-max)]

  Cases between September 2022 and January 2024

• Distribution of Intraoperative Administered Fluids (mL) [median (min-max)]

  Cases between September 2022 and January 2024

• Distribution of Intraoperative Fluid Balance (mL) Between Groups [median (min-max)]

  Cases between September 2022 and January 2024

• Comparison of Urine Output in the First 3 Postoperative Days Between and Within Groups [mean ± SD]

  Cases between September 2022 and January 2024

Study Arms (2)

Group 1: Patients without CCI-AKI

atients who did not develop CCI-AKI postoperatively (n=64). Observational data collected on demographics, RRI, intraoperative and postoperative factors.

Group 2: Patients with CCI-AKI

Patients who developed CCI-AKI postoperatively (n=26). Data includes renal failure staging, RRT requirements, complications, and outcomes.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing open heart surgery with cardiopulmonary bypass under general anesthesia

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bursa Yuksek Ihtisas Training and Research Hospital: lead

Study Sites (1)

Bursa High Specialization Training and Research Hospital

Bursa, 16000, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 21940396 BACKGROUND

• 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.

  PMID: 28074790 BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: anesthesiology and reanimation doctor

Study Record Dates

• First Submitted: December 27, 2024
• First Posted: January 24, 2025
• Study Start: September 1, 2022
• Primary Completion: January 15, 2024
• Study Completion: January 20, 2024
• Last Updated: January 27, 2025

Record last verified: 2025-01

Locations

TU (1)