- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06791304
Renal Resistive Index in Early Detection of Postoperative Acute Kidney Injury
January 23, 2025 updated by: Musa Harun UÇAR, Bursa Yüksek İhtisas Education and Research Hospital
Effectiveness of Doppler Renal Resistive Index in Early Detection of Postoperative Acute Kidney Injury in Prolonged Cardiopulmonary Bypass Cardiac Surgeries
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.
Study Overview
Status
Completed
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.
Study Type
Observational
Enrollment (Actual)
143
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bursa, Turkey, 16000
- Bursa High Specialization Training and Research Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Patients undergoing open heart surgery with cardiopulmonary bypass under general anesthesia
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Preoperative-postoperative percentage change of RRI (∆RRI) between two groups
Time Frame: Cases between September 2022 and January 2024
|
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
Time Frame: Cases between September 2022 and January 2024
|
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
Time Frame: Cases between September 2022 and January 2024
|
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
|
|
Comparison of preoperative, postoperative renal resistive index [median (min-max)]
Time Frame: Cases between September 2022 and January 2024
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hematocrit Change over Time [median (min-max)]
Time Frame: Cases between September 2022 and January 2024
|
The study will assess changes in intraoperative hematocrit (Hct) values over time.
Hct levels will be measured at predefined stages of the operation, including the warm-up period, and comparisons between the groups will be conducted to evaluate potential differences.
|
Cases between September 2022 and January 2024
|
|
Distribution of Intraoperative Urine Output (mL) [median (min-max)]
Time Frame: Cases between September 2022 and January 2024
|
The study will evaluate intraoperative urine output (mL) between the groups.
Urine output will be measured at three distinct time points: before cardiopulmonary bypass (CPB), during CPB, and after CPB.
|
Cases between September 2022 and January 2024
|
|
Distribution of Intraoperative Administered Fluids (mL) [median (min-max)]
Time Frame: Cases between September 2022 and January 2024
|
The study will evaluate the volume of fluids administered intraoperatively in both groups.
The total volume of fluids administered (mL) during the intraoperative period will be recorded and analyzed.
|
Cases between September 2022 and January 2024
|
|
Distribution of Intraoperative Fluid Balance (mL) Between Groups [median (min-max)]
Time Frame: Cases between September 2022 and January 2024
|
Fluid balance will be assessed intraoperatively as the difference between the total volume of fluids administered and the total output (urine and other losses).
This parameter will be reported in mL and analyzed to identify differences between the groups.
|
Cases between September 2022 and January 2024
|
|
Comparison of Urine Output in the First 3 Postoperative Days Between and Within Groups [mean ± SD]
Time Frame: Cases between September 2022 and January 2024
|
The study will evaluate postoperative urine output in both groups over the first three days following surgery.
Urine output will be measured daily, and comparisons will be conducted to assess differences between the groups at each time point.
|
Cases between September 2022 and January 2024
|
|
Comparison of Fluid Balance in the First 3 Postoperative Days Between and Within Groups[mean ± SD]
Time Frame: Cases between September 2022 and January 2024
|
The study will analyze 24-hour fluid balance values for the first three postoperative days.
Daily fluid balance values will be compared between the groups to identify potential differences at each time point.
|
Cases between September 2022 and January 2024
|
|
Intergroup and Intragroup Comparison of Postoperative First 3 Days sKr Values [median (min-max)]
Time Frame: Cases between September 2022 and January 2024
|
The study will assess serum creatinine (sCr) levels over the first three postoperative days.
Comparisons will be made between the groups to evaluate differences in sCr values at each time point.
|
Cases between September 2022 and January 2024
|
|
Comparison of Postoperative Duration of ICU Stay, Duration of Hospitalization Between Groups (day) [median (min-max)]
Time Frame: Cases between September 2022 and January 2024
|
This outcome measure will evaluate and compare the postoperative duration of ICU stay and the total duration of hospitalization (in days) between the two groups.
The duration of ICU stay will be recorded as the total number of days patients spend in the ICU after surgery, while the duration of hospitalization will include the total number of days from admission to discharge.
Both outcomes will be reported as median values (with minimum and maximum ranges) for each group.
Statistical analyses will be conducted to identify any significant differences between the groups.
|
Cases between September 2022 and January 2024
|
|
Comparison of duration of postoperative mechanical ventilation (hour) [median (min-max)]
Time Frame: Cases between September 2022 and January 2024
|
The study will compare the duration of postoperative mechanical ventilation between the groups.
This outcome measure will record the total time (in hours) that patients require mechanical ventilation following surgery.
Data will be presented as the median value with a range (minimum to maximum) to account for variability.
Statistical analyses will be conducted to identify any significant differences in mechanical ventilation duration between the groups.
|
Cases between September 2022 and January 2024
|
|
Comparison of Postoperative prolonged mechanical ventilation (>6 hours) Between Groups [median (min-max)]
Time Frame: Cases between September 2022 and January 2024
|
This outcome measure evaluates the incidence of prolonged postoperative mechanical ventilation, defined as ventilation duration exceeding 6 hours, in each group.
The data will be reported as the percentage of patients requiring prolonged mechanical ventilation, along with the median duration of ventilation and its range (min-max).
Statistical comparisons will be conducted to determine significant differences between the groups.
|
Cases between September 2022 and January 2024
|
|
Comparison of Postoperative 1-month mortality rate Between Groups [median (min-max)]
Time Frame: Cases between September 2022 and January 2024
|
The study will compare the postoperative 1-month mortality rate between the groups.
This outcome measure represents the proportion of patients who die within 30 days after surgery.
The mortality rate will be reported as a percentage and summarized using median (min-max) values for each group.
Statistical analyses will be conducted to evaluate differences in 1-month mortality rates between the groups.
|
Cases between September 2022 and January 2024
|
|
Postoperative Blood and Blood Products Transfusion, n (percent)
Time Frame: Cases between September 2022 and January 2024
|
The study will assess the number of erythrocyte suspension (ES) transfusions required in each group.
Subgroup analysis will be conducted to evaluate the incidence of transfusion requirements between the groups.
|
Cases between September 2022 and January 2024
|
|
KDIGO Stages in Patients with Renal Failure, n (percent)
Time Frame: Cases between September 2022 and January 2024
|
The study will assess the incidence of acute kidney injury (AKI) based on the Kidney Disease: Improving Global Outcomes (KDIGO) classification.
The KDIGO staging system categorizes AKI into three stages (Stage 1 to Stage 3) based on serum creatinine levels and urine output.
Higher stages indicate worse outcomes, reflecting greater severity of renal dysfunction.
The study will also evaluate the occurrence of renal failure, the need for renal replacement therapy (RRT), and the rate of permanent renal failure.
The timing of AKI onset and the need for interventions such as continuous renal replacement therapy (CRRT) or hemodialysis during the postoperative period will be monitored.
|
Cases between September 2022 and January 2024
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2022
Primary Completion (Actual)
January 15, 2024
Study Completion (Actual)
January 20, 2024
Study Registration Dates
First Submitted
December 27, 2024
First Submitted That Met QC Criteria
January 19, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 23, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011-KAEK-25 2022/08-16
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Renal Insufficiency, Acute
-
Centre Hospitalier Universitaire DijonCompletedPatients With Acute Renal InsufficiencyFrance
-
University Hospital, GrenobleRecruitingRenal Insufficiency | Renal Failure | Acute Renal Failure | Acute Renal InsufficiencyFrance
-
Vanessa Stadlbauer-Koellner, MDAustrian Science Fund (FWF)CompletedAcute Renal Failure | Chronic Renal InsufficiencyAustria
-
Icahn School of Medicine at Mount SinaiJohns Hopkins University; Mayo Clinic; National Institute of Diabetes and Digestive... and other collaboratorsRecruitingChronic Kidney Diseases | Acute Renal Failure | Acute Renal Injury | Acute Kidney Failure | Chronic Renal Insufficiency | Kidney Failure, Acute | Renal Insufficiency, Acute | Acute Renal Insufficiency | Acute Kidney Insufficiency | Renal Failure, Acute | Chronic Kidney Insufficiency | Chronic Renal Diseases | Kidney... and other conditionsUnited States
-
PfizerCompletedRenal Insufficiency, Chronic | Renal Insufficiency, Acute | Renal Disease, End-StageUnited States
-
Ziekenhuis Netwerk Antwerpen (ZNA)TerminatedRenal Replacement Therapy | Renal Insufficiency, AcuteBelgium
-
University of WashingtonJohns Hopkins University; National Institute of Diabetes and Digestive and... and other collaboratorsCompletedCovid19 | Acute Renal Failure | Acute Renal Injury | Acute Kidney Failure | Kidney Failure, Acute | Renal Insufficiency, Acute | Acute Renal Insufficiency | Sars-CoV-2 Infection | Acute Kidney Insufficiency | Renal Failure, Acute | Kidney Insufficiency, AcuteUnited States
-
Medizinisches Versorgungszentrum Diaverum PotsdamUniversity of Magdeburg; Ernst von Bergmann HospitalRecruitingAcute Renal InsufficiencyGermany
-
Saint-Joseph UniversityUnknown
-
Rempex (a wholly owned subsidiary of Melinta Therapeutics...Innovative Medicines Initiative; Universitätsklinikum KölnTerminatedRenal Insufficiency, Chronic | Healthy Subjects | Renal Insufficiency, AcuteGermany