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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05929573
Other study ID # Ercan01
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 2023
Est. completion date March 2024

Study information

Verified date July 2023
Source Antalya Training and Research Hospital
Contact Ercan AYDEMIR, MD
Phone +902422494400
Email ercanaydmir521@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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?'


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 44
Est. completion date March 2024
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - ASA I-III, - Patients undergoing elective major abdominal surgery Exclusion Criteria: - Chronic kidney failure, - Using nephrotoxic drugs, - Patients with a history of kidney transplantation or nephrectomy

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Neutrophil Gelatinase-Associated Lipocalin
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 Index
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Antalya Training and Research Hospital

References & Publications (2)

Muthukrishnan 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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Plasma NGAL Level From patients undergoing major abdominal surgery, a blood sample will be taken at Postop 4th Hour for serum NGAL analysis Postoperative 4th hour
Primary Renal Doppler Resistive Index Renal Doppler Resistive Index will be measured at the 4th hour after major abdominal surgery. Postoperative 4th hour
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