RDRI and NGAL in Acute Kidney Injury in Abdominal Surgery

Acute Kidney Injury Clinical Trial

Official title:

Efficacy of Renal Doppler Resistive Index and Neutrophil Gelatinase-Associated Lipocalin Measurement in Detecting Acute Kidney Injury in Major Abdominal Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05929573
• Other study ID #: Ercan01
• Status: Not yet recruiting
• 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
• 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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Wounds and Injuries

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