Intraoperative NGAL Level in Geriatric Patients Undergoing Laparotomy

NCT05030727 | Completed DMC

• 1 other identifier: 09.2021.392
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to detect early renal dysfunction that may occur during the surgical procedure in geriatric patients who will undergo laparotomy surgery. In elderly patients undergoing surgery, accurate estimation of organ function is often not possible. Accurate measurement of kidney function is vital to the routine care of patients. Determining kidney function status can predict the progression of kidney disease and prevent toxic drug levels in the body.The biochemical marker creatinine, found in serum and urine, is widely used in the estimation of GFR. Although glomerular filtration rate decreases with aging, creatinine also decreases in the elderly due to muscle loss. Even moderately elevated blood creatinine may be indicative of severe kidney failure. Creatinine clearance (CrCl) is the volume of blood plasma cleared of creatinine per unit time. It is a fast and cost-effective method for measuring kidney function. Creatine is a breakdown product of creatine phosphate found in skeletal muscle. Its production in the body depends on muscle mass. The CrCl ratio approximates the GFR calculation as it freely filters the glomerular creatine. High serum creatinine levels and decreased CrCl ratio are usually indicators of abnormal kidney function.One of the markers of acute kidney injury is to look at plasma NGAL values. Plasma NGAL (neutrophil gelatinase associated lipocalin) increases in response to damaged kidney status and can predict acute kidney injury as an early marker. Data on investigating plasma NGAL values as a predictive biomarker of acute kidney injury in patients undergoing non-cardiovascular surgery are very limited NGAL is produced from the epithelium of kidneys, lungs, colon, liver, adipose tissue, and inflammatory cells. NGAL is elevated in serum and urine after acute tubular injury, making it possible to diagnose kidney damage within 2 hours of injury. However, the increase of other traditional markers such as creatinine may be delayed for up to 48 hours after acute kidney injury.To determine the roles of primary outcome serum creatinine, creatinine clearance rates and plasma NGAL levels in the diagnosis of acute renal failure

Conditions

Geriatric Presentation of Urinary Tract Infection; Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• the roles of plasma NGAL levels in acute renal failure.

  roles of plasma NGAL levels in the diagnosis of acute renal failure.

  first 24 hours after surgery

Study Arms (1)

Evaluation of intraoperative NGAL levels in terms of acute kidney injury in geriatric patients

OTHER

only one group

Diagnostic Test: record of pNGAL

Interventions

record of pNGAL DIAGNOSTIC_TEST

Preoperative (0.hour baseline), postoperative 24.,48. BUN, Creatinine, Lactate values in the blood of the patients at 1 hour, and for plasma NGAL, blood samples will be taken at the preoperative, postoperative 6th and 24th hours. And the results will be recorded.

Evaluation of intraoperative NGAL levels in terms of acute kidney injury in geriatric patients

Eligibility Criteria

• Age: 64 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 64 years and older (ASA I-II-III class), who were to undergo major abdominal laparotomy surgery, whose consent forms were obtained, were included in the study.

You may not qualify if:

• Patients with severe cardiac and respiratory distress, liver and kidney failure, and those who did not consent to the study will not be accepted into the study.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University

Istanbul, Maltepe, 34854, Turkey (Türkiye)

Location

Related Publications (1)

• Orhon Ergun M, Zengin SU, Mustafayeva A, Umuroglu T. Neutrophil gelatinase associated lipocalin in predicting postoperative acute kidney injury in elderly. Ir J Med Sci. 2022 Jun;191(3):1297-1303. doi: 10.1007/s11845-021-02865-z. Epub 2021 Nov 25.

  PMID: 34822023 DERIVED

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

• MELIHA ORHON ERGUN

  Marmara University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: September 1, 2021
• Study Start: March 5, 2021
• Primary Completion: September 2, 2021
• Study Completion: September 10, 2021
• Last Updated: October 8, 2021

Record last verified: 2021-10

Locations

TU (1)