Neutrophil Gelatinase-associated Lipocalin in Major Abdominal Surgery

NCT05721638 | Completed

• 1 other identifier: Erhanter01
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Plasma NGAL Level

  From patients undergoing major abdominal surgery, a blood sample will be taken at Postop 4th Hour for serum NGAL analysis.

  Postoperative 4th hour

• Urine NGAL level

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

  Postoperative 4th hour

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• ASA I-III,
• Patients undergoing elective major abdominal surgery

You may not qualify if:

• Chronic renal failure,
• Using nephrotoxic drugs,
• Patients with a history of kidney transplantation or nephrectomy

Sponsors & Collaborators

• Antalya Training and Research Hospital: lead

Study Sites (1)

Antalya Training and Research Hospital

Antalya, Turkey (Türkiye)

Location

Related Publications (1)

• Pan HC, Yang SY, Chiou TT, Shiao CC, Wu CH, Huang CT, Wang TJ, Chen JY, Liao HW, Chen SY, Huang TM, Yang YF, Lin HY, Chan MJ, Sun CY, Chen YT, Chen YC, Wu VC. Comparative accuracy of biomarkers for the prediction of hospital-acquired acute kidney injury: a systematic review and meta-analysis. Crit Care. 2022 Nov 12;26(1):349. doi: 10.1186/s13054-022-04223-6.

  PMID: 36371256 BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Erhan OZYURT, MD

  Antalya Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 1, 2023
• First Posted: February 10, 2023
• Study Start: June 1, 2023
• Primary Completion: November 30, 2023
• Study Completion: December 31, 2023
• Last Updated: January 31, 2024

Record last verified: 2024-01

Locations

TU (1)