Renal Insufficiency, AcuteNCT06791304
Renal Resistive Index in Early Detection of Postoperative Acute Kidney Injury
An observational study of Renal Insufficiency, Acute and Cardiac Surgery Associated - Acute Kidney Injury, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Insufficiency, Acute, Cardiac Surgery Associated - Acute Kidney Injury
- How many people
- 143 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2022to 20 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing open heart surgery with cardiopulmonary bypass under general anesthesia
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bursa High Specialization Training and Research Hospital
Bursa, 16000
About this study
Official title: 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.
Read the 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.
- Keywords
- acute kidney injury, early detection, renal artery, doppler ultrasonography, cardiopulmonary bypass
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Cases between September 2022 and January 2024
Secondary outcomes (13)
Hematocrit Change over Time [median (min-max)]
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.
Measured: Cases between September 2022 and January 2024
Distribution of Intraoperative Urine Output (mL) [median (min-max)]
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.
Measured: Cases between September 2022 and January 2024
Distribution of Intraoperative Administered Fluids (mL) [median (min-max)]
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.
Measured: Cases between September 2022 and January 2024
Distribution of Intraoperative Fluid Balance (mL) Between Groups [median (min-max)]
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.
Measured: Cases between September 2022 and January 2024
Comparison of Urine Output in the First 3 Postoperative Days Between and Within Groups [mean ± SD]
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.
Measured: Cases between September 2022 and January 2024
Comparison of Fluid Balance in the First 3 Postoperative Days Between and Within Groups[mean ± SD]
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.
Measured: Cases between September 2022 and January 2024
Intergroup and Intragroup Comparison of Postoperative First 3 Days sKr Values [median (min-max)]
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.
Measured: Cases between September 2022 and January 2024
Comparison of Postoperative Duration of ICU Stay, Duration of Hospitalization Between Groups (day) [median (min-max)]
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.
Measured: Cases between September 2022 and January 2024
Comparison of duration of postoperative mechanical ventilation (hour) [median (min-max)]
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.
Measured: Cases between September 2022 and January 2024
Comparison of Postoperative prolonged mechanical ventilation (>6 hours) Between Groups [median (min-max)]
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.
Measured: Cases between September 2022 and January 2024
Comparison of Postoperative 1-month mortality rate Between Groups [median (min-max)]
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.
Measured: Cases between September 2022 and January 2024
Postoperative Blood and Blood Products Transfusion, n (percent)
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.
Measured: Cases between September 2022 and January 2024
KDIGO Stages in Patients with Renal Failure, n (percent)
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.
Measured: Cases between September 2022 and January 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start1 Sep 2022
- Primary completion15 Jan 2024
- Study completion20 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Renal Insufficiency, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Musa Harun UÇAR, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06791304
- Sponsor's protocol ID
- 2011-KAEK-25 2022/08-16
- Status last verified
- Jan 2025
- First submitted
- 27 Dec 2024
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 21940396Karim 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.
PubMed 28074790
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Doppler Renal Resistive Index in Early Detection of Postoperative Acute Kidney Injury in Prolonged Cardiopulmonary Bypass Cardiac Surgeries
- ClinicalTrials.gov ID
- NCT06791304
- Acronym / sponsor ID
- 2011-KAEK-25 2022/08-16
- Keywords
- acute kidney injury, early detection, renal artery, doppler ultrasonography, cardiopulmonary bypass
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 20 Jan 2024 (actual)
- First posted
- 24 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing open heart surgery with cardiopulmonary bypass under general anesthesia
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
13 secondary outcomes
Hematocrit Change over Time [median (min-max)]
Time frame: 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
Distribution of Intraoperative Administered Fluids (mL) [median (min-max)]
Time frame: 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
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
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
Intergroup and Intragroup Comparison of Postoperative First 3 Days sKr Values [median (min-max)]
Time frame: 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
Comparison of duration of postoperative mechanical ventilation (hour) [median (min-max)]
Time frame: 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
Comparison of Postoperative 1-month mortality rate Between Groups [median (min-max)]
Time frame: Cases between September 2022 and January 2024
Postoperative Blood and Blood Products Transfusion, n (percent)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Results publication: PubMed 21940396Bossard 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.
- Results publication: PubMed 28074790Karim 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Insufficiency, Acute and Cardiac Surgery Associated - Acute Kidney Injury, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of preoperative, postoperative renal resistive index [median (min-max)] (time frame: Cases between September 2022 and January 2024). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06791304, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.