Neutrophil Gelatinase-associated Lipocalin in Major Abdominal Surgery

Sponsor
Antalya Training and Research Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05721638
Collaborator
(none)
45
1
6.9
6.5

Study Details

Study Description

Brief Summary

Acute kidney injury (AKI) after major surgery is a well-known complication. The incidence of AKI after major surgery ranges from 13% to 50%. The morbidity and mortality rates increase in patients with AKI due to the treatments applied and the prolonged hospital stay. In addition, as a result of all these processes, hospital costs increase and burden the health systems.

Classifications such as Acute Kidney Injury Network (AKIN) or Kidney Disease Improving Global Outcomes (KDIGO) are used in the diagnosis of AKI. In these classifications, evaluation is made based on kidney damage, serum creatinine (Scr), and urine output. However, Scr; is affected by factors such as age, gender, diet, muscle mass, and medication. In addition, in healthy individuals in terms of kidney reserve, a loss of up to 50% in nephrons is tolerated by the body and there is no change in Scr values. Therefore, the onset of the increase in Scr values occurs 48-72 hours after kidney damage. This situation causes delays in the treatments applied and increases morbidity and mortality rates.

For these reasons, interest in biomarkers used in the early diagnosis of AKI has increased in recent years. Neutrophil gelatinase-associated lipocalin (NGAL) is a 25 KDa, neutrophil-derived molecule from the lipocalin family. It is also secreted in small amounts from kidney, prostate, and respiratory tract epithelial cells. After ischemic and nephrotoxic acute tubular necrosis, NGAL levels peak at the 3rd hour and remain elevated for approximately 24 hours. In patients who do not progress to AKI, NGAL levels begin to decrease in the 1st hour after injury.

When the current literature is examined, scientific studies on NGAL have mostly been carried out on cardiovascular surgery cases to date. There are very few studies evaluating NGAL levels in patients who develop AKI after major abdominal surgery. These few studies evaluated either serum NGAL or urinary NGAL levels. In this study, both serum NGAL and urinary NGAL will be measured simultaneously to detect AKI that may develop in patients undergoing major abdominal surgery. We think that the results we will obtain here will guide the studies on NGAL.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Neutrophil gelatinase-associated lipocalin

Study Design

Study Type:
Observational
Anticipated Enrollment :
45 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Efficacy of Serum and Urinary Neutrophil Gelatinase-associated Lipocalin in the Early Detection of Acute Kidney Injury After Major Abdominal Surgery
Actual Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Jul 31, 2023
Anticipated Study Completion Date :
Aug 31, 2023

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. Urine NGAL level [Postoperative 4th hour]

    Urine samples will be collected from patients undergoing major abdominal surgery at the 4th postoperative hour for urine NGAL analysis.

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 renal failure,

  • Using nephrotoxic drugs,

  • Patients with a history of kidney transplantation or nephrectomy

Contacts and Locations

Locations

Site City State Country Postal Code
1 Antalya Training and Research Hospital Antalya Turkey

Sponsors and Collaborators

  • Antalya Training and Research Hospital

Investigators

  • Principal Investigator: Erhan OZYURT, MD, Antalya Training and Research Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Erhan Ozyurt, Associate Professor, Antalya Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT05721638
Other Study ID Numbers:
  • Erhanter01
First Posted:
Feb 10, 2023
Last Update Posted:
Feb 10, 2023
Last Verified:
Feb 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, Antalya Training and Research Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 10, 2023