RDRI and NGAL in Acute Kidney Injury in Abdominal Surgery

Sponsor
Antalya Training and Research Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05929573
Collaborator
(none)
44
8

Study Details

Study Description

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?'

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Neutrophil Gelatinase-Associated Lipocalin
  • Diagnostic Test: Renal Doppler Resistive Index

Study Design

Study Type:
Observational
Anticipated Enrollment :
44 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Efficacy of Renal Doppler Resistive Index and Neutrophil Gelatinase-Associated Lipocalin Measurement in Detecting Acute Kidney Injury in Major Abdominal Surgery
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Mar 1, 2024

Outcome Measures

Primary Outcome Measures

  1. Plasma NGAL Level [Postoperative 4th hour]

    From patients undergoing major abdominal surgery, a blood sample will be taken at Postop 4th Hour for serum NGAL analysis

  2. Renal Doppler Resistive Index [Postoperative 4th hour]

    Renal Doppler Resistive Index will be measured at the 4th hour after major abdominal surgery.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Antalya Training and Research Hospital

Investigators

  • Principal Investigator: Erhan OZYURT, Assoc. Prof., Antalya Training and Research Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Erhan Ozyurt, Associate Professor, M.D., Antalya Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT05929573
Other Study ID Numbers:
  • Ercan01
First Posted:
Jul 3, 2023
Last Update Posted:
Jul 5, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Erhan Ozyurt, Associate Professor, M.D., Antalya Training and Research Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 5, 2023