Evaluation of Kidney Damage Using NGAL Measurements

Recruiting

• Conditions: Neutrophil Gelatinase-Associated Lipocalin; Prostatectomy; Kidney Function Tests
• Interventions: Procedure: Robotic-Assisted Laparoscopic Radical Prostatectomy

• Registration Number: NCT06274125
• Lead Sponsor: Ankara City Hospital Bilkent

Brief Summary

The main objective of this study is to evaluate whether blood NGAL measurement provides superiority over sCr and BUN tests in early diagnosis for assessing renal function in patients undergoing robotic urological surgery.

Detailed Description

The main objective of this study is to evaluate whether blood NGAL measurement provides superiority over sCr and BUN tests in early diagnosis for assessing renal function in patients undergoing robotic urological surgery.

The secondary objective of the study is to evaluate the relationship between AKI development and monitored parameters such as age, BMI, comorbidities, ASA, OAB (overactive bladder), mean arterial pressure, intraabdominal pressure, surgical duration, urea and creatinine levels.

After obtaining ethical approval from the Ministry of Health Ankara City Hospital Oncology Operating Room, a total of 55 patients between the ages of 18-80, ASA 1-3, who will undergo general anesthesia under elective conditions will be included in this prospective observational study.

During the preoperative period, patients will be evaluated and provided with written informed consent. Before being taken to the operating room, patients' age, gender, weight, height, body mass index (BMI), comorbidities, regular medication use, ASA classification, hemodynamic values and laboratory values will be recorded in the waiting area. Once in the operating room, patients will be monitored according to the standard working protocol of the anesthesia clinic including non-invasive arterial blood pressure monitoring, 3 or 5-channel ECG and pulse oximetry. Additionally, standard preoperative and postoperative biochemical profiles (including hemogram) and urinary NGAL levels will be measured.

During the perioperative period, routine hemodynamic parameters such as heart rate (HR) (beats per minute), systolic arterial blood pressure (SAB) (mmHg), diastolic arterial blood pressure (DAB) (mmHg), mean arterial blood pressure (OAB)(mmHg), peripheral oxygen saturation(SpO2) as well as postoperative laboratory values will be recorded.

Blood samples for NGAL measurements will be collected at preoperative and perioperative hours 2nd and 6th. Creatinine clearance calculation,hourly urine output; which are commonly used markers to evaluate acute kidney injury(AKI) along with standard laboratory parameters,and other complications related to AKI management ,will also be recorded.

Study Timeline

• Study Start: 2023-10-01
• Status Verified: 2024-02
• Study First Submitted: 2024-02-16
• Study First Submitted QC: 2024-02-16
• Last Update Submitted: 2024-02-16
• Study First Posted: 2024-02-23
• Last Update Posted: 2024-02-23
• Primary Completion: 2024-03
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 55

Inclusion Criteria

• A total of 55 patients, with ASA scores 1-2-3, aged between 18 and 80 years, will be included in the study conducted at the Robotic Surgery operating room of Ankara City Hospital, Ministry of Health, Turkey.

Exclusion Criteria

-1. Individuals who do not have the ability to read, understand, or sign the consent form.

2. Individuals with diagnosed renal disease. 3. Patients who do not wish to participate in the study. 4. Patients classified as ASA-3 or higher.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NGAL measurement for evaluating kidney damage in patients undergoing robotic radical prostatectomy.	Robotic-Assisted Laparoscopic Radical Prostatectomy	For the evaluation of kidney damage in patients undergoing robotic radical prostatectomy, blood samples will be collected at preoperative and perioperative 2nd and 6th hours to measure NGAL values.

Primary Outcome Measures

Name	Time	Method
The main objective of this study is to evaluate whether blood NGAL measurement has superiority over sCr and BUN tests in terms of early diagnosis for assessing kidney function in patients undergoing robotic urologic surgery.	For the evaluation of kidney damage in patients undergoing robotic radical prostatectomy, blood samples will be collected at preoperative and perioperative 2nd and 6th hours to measure NGAL values.

Secondary Outcome Measures

Name	Time	Method
The relationship between demographic parameters such as age, BMI, comorbidities, and ASA classification will be evaluated in relation to the development of AKI.	For the evaluation of kidney damage in patients undergoing robotic radical prostatectomy, blood samples will be collected at preoperative and perioperative 2nd and 6th hours to measure NGAL values.
The evaluation of the relationship between intraabdominal pressure and the development of AKI.	The relationship between intraabdominal pressure monitoring during surgery and NGAL values obtained at 0, 2, and 6 hours.
The relationship between intraoperative mean arterial pressure (MAP) and NGAL (Neutrophil Gelatinase-Associated Lipocalin) values.	The relationship between intraoperative mean arterial pressure monitoring and NGAL values obtained at 0, 2, and 6 hours.

Trial Locations

Locations (1)

Ankara Bilkent City Hospital; 🇹🇷 Ankara, Çankaya, Turkey