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Neutrophil Gelatinase-associated Lipocalin in Major Abdominal Surgery

Efficacy of Serum and Urinary Neutrophil Gelatinase-associated Lipocalin in the Early Detection of Acute Kidney Injury After Major Abdominal Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05721638
Enrollment
43
Registered
2023-02-10
Start date
2023-06-01
Completion date
2023-12-31
Last updated
2024-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury

Keywords

Acute Kidney Injury, Neutrophil gelatinase-associated lipocalin, Major abdominal surgery

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.

Interventions

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 as of the 1st hour after injury.

Sponsors

Antalya Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Plasma NGAL LevelPostoperative 4th hourFrom patients undergoing major abdominal surgery, a blood sample will be taken at Postop 4th Hour for serum NGAL analysis.
Urine NGAL levelPostoperative 4th hourUrine samples will be collected from patients undergoing major abdominal surgery at the 4th postoperative hour for urine NGAL analysis.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026