Acute Kidney InjuryNCT05929573
RDRI and NGAL in Acute Kidney Injury in Abdominal Surgery
An observational study of Acute Kidney Injury, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Acute kidney injury (AKI), which can occur after major surgeries, leads to increased morbidity and mortality if not detected and managed promptly. In clinical practice, serum creatinine and urine output values of patients are monitored to detect AKI, but these parameters can cause delays in diagnosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Neutrophil Gelatinase-Associated Lipocalin and Renal Doppler Resistive Index
- How many people
- 43 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2023to 20 Jul 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 who will undergo major abdominal surgery in Antalya Training and Research Hospital.
Who may be able to join
- ASA I-III,
- Patients undergoing elective major abdominal surgery
Who cannot join
- Chronic kidney failure,
- Using nephrotoxic drugs,
- Patients with a history of kidney transplantation or nephrectomy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Antalya Training and Research Hospital
Antalya
About this study
Official title: Efficacy of Renal Doppler Resistive Index and Neutrophil Gelatinase-Associated Lipocalin Measurement in Detecting Acute Kidney Injury in Major Abdominal Surgery
Acute kidney injury (AKI), which can occur after major surgeries, leads to increased morbidity and mortality if not detected and managed promptly. In clinical practice, serum creatinine and urine output values of patients are monitored to detect AKI, but these parameters can cause delays in diagnosis. Additionally, studies have been conducted on biomarkers such as Neutrophil Gelatinase-Associated Lipocalin (NGAL) and cystatin C in recent years, but definitive results have not been achieved.
Renal Doppler Resistive Index (RDRI) is a non-invasive index believed to reflect renal vascular perfusion. RDRI measurement is a repeatable, inexpensive, and easy-to-apply technique. RDRI has been found to be associated with AKI in conditions such as renal dysfunction, hypertension, and post-traumatic hemorrhagic shock. Furthermore, due to the impact on renal perfusion in patients undergoing major surgery, RDRI, which reflects renal vascular resistance, can serve as an indicator of kidney perfusion.
The aim of this study is to test the hypothesis, 'Does measuring postoperative RDRI in major abdominal surgery cases yield higher sensitivity and specificity values in detecting acute kidney injury compared to NGAL?'
- Conditions
- Acute Kidney Injury
- Being tested
- Neutrophil Gelatinase-Associated Lipocalin, Renal Doppler Resistive Index
- Keywords
- Acute kidney injury, Neutrophil Gelatinase-Associated Lipocalin, Renal Doppler Resistive Index, Major Abdominal Surgery
- 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.
Neutrophil Gelatinase-Associated LipocalinDiagnostic test
Neutrophil Gelatinase-Associated Lipocalin, which can be measured from serum or urine, can detect acute kidney failure that may occur after surgery in the early stages.
Renal Doppler Resistive IndexDiagnostic test
Renal Doppler Resistive Index (RDRI) is a non-invasive index believed to reflect renal vascular perfusion. RDRI measurement is a repeatable, inexpensive, and easy-to-apply technique. RDRI has been found to be associated with AKI in conditions such as renal dysfunction, hypertension, and post-traumatic hemorrhagic shock. Furthermore, due to the impact on renal perfusion in patients undergoing major surgery, RDRI, which reflects renal vascular resistance, can serve as an indicator of kidney perfusion.
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma NGAL Level
From patients undergoing major abdominal surgery, a blood sample will be taken at Postop 4th Hour for serum NGAL analysis
Measured: Postoperative 4th hour
Renal Doppler Resistive Index
Renal Doppler Resistive Index will be measured at the 4th hour after major abdominal surgery.
Measured: Postoperative 4th hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start1 Jul 2023
- Primary completion31 Dec 2023
- Study completion20 Jul 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 Acute Kidney InjuryStudies 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
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Erhan Ozyurt, Antalya Training and Research Hospital
- Investigators
- Erhan OZYURT, Assoc. Prof., Principal investigator, Antalya Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05929573
- Sponsor's protocol ID
- Ercan01
- Status last verified
- Jul 2024
- First submitted
- 25 Jun 2023
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zeng X, McMahon GM, Brunelli SM, Bates DW, Waikar SS. Incidence, outcomes, and comparisons across definitions of AKI in hospitalized individuals. Clin J Am Soc Nephrol. 2014 Jan;9(1):12-20. doi: 10.2215/CJN.02730313. Epub 2013 Oct 31.
PubMed 24178971Muthukrishnan K, Parida S, Barathi SD, Badhe AS, Mishra SK. Doppler resistive index to reflect risk of acute kidney injury after major abdominal surgery: A prospective observational trial. Indian J Anaesth. 2019 Jul;63(7):551-557. doi: 10.4103/ija.IJA_189_19.
PubMed 31391618
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Renal Doppler Resistive Index and Neutrophil Gelatinase-Associated Lipocalin Measurement in Detecting Acute Kidney Injury in Major Abdominal Surgery
- ClinicalTrials.gov ID
- NCT05929573
- Acronym / sponsor ID
- Ercan01
- Conditions
- Acute Kidney Injury
- Keywords
- Acute kidney injury, Neutrophil Gelatinase-Associated Lipocalin, Renal Doppler Resistive Index, Major Abdominal Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 20 Jul 2024 (actual)
- First posted
- 3 Jul 2023 (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.
Acute kidney injury (AKI), which can occur after major surgeries, leads to increased morbidity and mortality if not detected and managed promptly. In clinical practice, serum creatinine and urine output values of patients are monitored to detect AKI, but these parameters can cause delays in diagnosis. Additionally, studies have been conducted on biomarkers such as Neutrophil Gelatinase-Associated Lipocalin (NGAL) and cystatin C in recent years, but definitive results have not been achieved.
Renal Doppler Resistive Index (RDRI) is a non-invasive index believed to reflect renal vascular perfusion. RDRI measurement is a repeatable, inexpensive, and easy-to-apply technique. RDRI has been found to be associated with AKI in conditions such as renal dysfunction, hypertension, and post-traumatic hemorrhagic shock. Furthermore, due to the impact on renal perfusion in patients undergoing major surgery, RDRI, which reflects renal vascular resistance, can serve as an indicator of kidney perfusion.
The aim of this study is to test the hypothesis, 'Does measuring postoperative RDRI in major abdominal surgery cases yield higher sensitivity and specificity values in detecting acute kidney injury compared to NGAL?'
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who will undergo major abdominal surgery in Antalya Training and Research Hospital.
Key inclusion criteria (2 listed)
- ASA I-III,
- Patients undergoing elective major abdominal surgery
Key exclusion criteria (3 listed)
- Chronic kidney failure,
- Using nephrotoxic drugs,
- Patients with a history of kidney transplantation or nephrectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neutrophil Gelatinase-Associated LipocalinNeutrophil Gelatinase-Associated Lipocalin, which can be measured from serum or urine, can detect acute kidney failure that may occur after surgery in the early stages. | Diagnostic test | – |
| Renal Doppler Resistive IndexRenal Doppler Resistive Index (RDRI) is a non-invasive index believed to reflect renal vascular perfusion. RDRI measurement is a repeatable, inexpensive, and easy-to-apply technique. RDRI has been found to be associated with AKI in conditions such as renal dysfunction, hypertension, and post-traumatic hemorrhagic shock. Furthermore, due to the impact on renal perfusion in patients undergoing major surgery, RDRI, which reflects renal vascular resistance, can serve as an indicator of kidney perfusion. | Diagnostic test | – |
Primary outcome
Plasma NGAL Level
Time frame: Postoperative 4th hour
From patients undergoing major abdominal surgery, a blood sample will be taken at Postop 4th Hour for serum NGAL analysis
Renal Doppler Resistive Index
Time frame: Postoperative 4th hour
Renal Doppler Resistive Index will be measured at the 4th hour after major abdominal surgery.
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 30 Jul 2024.
- Background: PubMed 24178971Zeng X, McMahon GM, Brunelli SM, Bates DW, Waikar SS. Incidence, outcomes, and comparisons across definitions of AKI in hospitalized individuals. Clin J Am Soc Nephrol. 2014 Jan;9(1):12-20. doi: 10.2215/CJN.02730313. Epub 2013 Oct 31.
- Background: PubMed 31391618Muthukrishnan K, Parida S, Barathi SD, Badhe AS, Mishra SK. Doppler resistive index to reflect risk of acute kidney injury after major abdominal surgery: A prospective observational trial. Indian J Anaesth. 2019 Jul;63(7):551-557. doi: 10.4103/ija.IJA_189_19.
- 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.
Erhan OZYURT, Assoc. Prof. principal investigator
Antalya Training and Research Hospital
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 Acute Kidney Injury, run by Antalya 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 2 inclusion and 3 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 30 Jul 2024. 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?
Plasma NGAL Level (time frame: Postoperative 4th hour). The study lists 2 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 NCT05929573, 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 30 Jul 2024.