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NCT Number: NCT05721638

Neutrophil Gelatinase-associated Lipocalin in Major Abdominal Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Antalya Training and Research Hospital

Antalya, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neutrophil Gelatinase-Associated Lipocalin

Diagnostic Test

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.

Primary outcomes

  1. Plasma NGAL Level

    Time frame: 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

    Time frame: Postoperative 4th hour

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

Sponsors and collaborators

Lead sponsor

Antalya Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 10, 2023
Registry last updated
Jan 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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