Clinical trial NCT05929573: RDRI and NGAL in Acute Kidney Injury in Abdominal Surgery
Official title: Efficacy of Renal Doppler Resistive Index and Neutrophil Gelatinase-Associated Lipocalin Measurement in Detecting Acute Kidney Injury in Major Abdominal Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Keywords: Acute kidney injury
Neutrophil Gelatinase-Associated Lipocalin
Renal Doppler Resistive Index
Major Abdominal Surgery
Lead sponsor: Antalya Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2023-07-03
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who will undergo major abdominal surgery in Antalya Training and Research Hospital.

Brief 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?'


Eligibility criteria: 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

Primary outcomes:
measure: Plasma NGAL Level
timeFrame: Postoperative 4th hour
measure: Renal Doppler Resistive Index
timeFrame: Postoperative 4th hour
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Antalya Training and Research Hospital
Study officials:
affiliation: Antalya Training and Research Hospital
name: Erhan OZYURT, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.