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Neutrophil Gelatinase-associated Lipocalin in Major Abdominal Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05721638
Recruitment Status : Recruiting
First Posted : February 10, 2023
Last Update Posted : February 24, 2023
Sponsor:
Information provided by (Responsible Party):
Erhan Ozyurt, Antalya Training and Research Hospital

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.


Condition or disease Intervention/treatment
Acute Kidney Injury Diagnostic Test: Neutrophil gelatinase-associated lipocalin

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Study Type : Observational
Estimated 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 : February 1, 2023
Estimated Primary Completion Date : July 31, 2023
Estimated Study Completion Date : August 31, 2023

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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.


Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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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
Study Population
Patients who will undergo major abdominal surgery in Antalya Training and Research Hospital.
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Erhan OZYURT +902422494400 eozyurt@hotmail.com

Locations
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Turkey
Antalya Training and Research Hospital Recruiting
Antalya, Turkey
Contact: Erhan Ozyurt    +902422494400    eozyurt@hotmail.com   
Principal Investigator: Erhan OZYURT         
Sponsors and Collaborators
Antalya Training and Research Hospital
Investigators
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Principal Investigator: Erhan OZYURT, MD Antalya Training and Research Hospital
Publications:
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Responsible Party: Erhan Ozyurt, Associate Professor, Antalya Training and Research Hospital
ClinicalTrials.gov Identifier: NCT05721638    
Other Study ID Numbers: Erhanter01
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Erhan Ozyurt, Antalya Training and Research Hospital:
Acute Kidney Injury
Neutrophil gelatinase-associated lipocalin
Major abdominal surgery
Additional relevant MeSH terms:
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Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases