Neutrophil Gelatinase-associated Lipocalin in Major Abdominal Surgery
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|ClinicalTrials.gov Identifier: NCT05721638|
Recruitment Status : Recruiting
First Posted : February 10, 2023
Last Update Posted : February 24, 2023
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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.
|Condition or disease||Intervention/treatment|
|Acute Kidney Injury||Diagnostic Test: Neutrophil gelatinase-associated lipocalin|
|Study Type :||Observational|
|Estimated Enrollment :||45 participants|
|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 :||February 1, 2023|
|Estimated Primary Completion Date :||July 31, 2023|
|Estimated Study Completion Date :||August 31, 2023|
- Diagnostic Test: Neutrophil gelatinase-associated lipocalin
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.
- 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.
- 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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Probability Sample|
- ASA I-III,
- Patients undergoing elective major abdominal surgery
- Chronic renal failure,
- Using nephrotoxic drugs,
- Patients with a history of kidney transplantation or nephrectomy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05721638
|Contact: Erhan OZYURTfirstname.lastname@example.org|
|Antalya Training and Research Hospital||Recruiting|
|Contact: Erhan Ozyurt +902422494400 email@example.com|
|Principal Investigator: Erhan OZYURT|
|Principal Investigator:||Erhan OZYURT, MD||Antalya Training and Research Hospital|
|Responsible Party:||Erhan Ozyurt, Associate Professor, Antalya Training and Research Hospital|
|Other Study ID Numbers:||
|First Posted:||February 10, 2023 Key Record Dates|
|Last Update Posted:||February 24, 2023|
|Last Verified:||February 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Acute Kidney Injury
Neutrophil gelatinase-associated lipocalin
Major abdominal surgery
Acute Kidney Injury
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Male Urogenital Diseases