Evaluation of Kidney Damage Using NGAL Measurements

NCT06274125 | Recruiting

• 1 other identifier: AslıDemircioglu1
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatectomy; Neutrophil Gelatinase-Associated Lipocalin; Kidney Function Tests

Keywords

robotic surgery; Neutrophil Gelatinase-Associated Lipocalin; Acute kidney injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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.

Study Arms (1)

NGAL measurement for evaluating kidney damage in patients undergoing robotic 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.

Procedure: Robotic-Assisted Laparoscopic Radical Prostatectomy

Interventions

Robotic-Assisted Laparoscopic Radical Prostatectomy PROCEDURE

To evaluate kidney damage in patients undergoing robotic radical prostatectomy, NGAL measurement will be performed.

NGAL measurement for evaluating kidney damage in patients undergoing robotic radical prostatectomy.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Participants were selected from male individuals as the evaluation was conducted on patients undergoing prostatectomy.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• Individuals who do not have the ability to read, understand, or sign the consent form.
• \. Individuals with diagnosed renal disease. 3. Patients who do not wish to participate in the study. 4. Patients classified as ASA-3 or higher.

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Çankaya, 06530, Turkey (Türkiye)

RECRUITING

Related Publications (6)

• Savran Karadeniz M, Alp Eniste I, Senturk Ciftci H, Usta S, Tefik T, Sanli O, Pembeci K, Tugrul KM. Neutrophil Gelatinase-associated Lipocalin Significantly Correlates with Ischemic Damage in Patients Undergoing Laparoscopic Partial Nephrectomy. Balkan Med J. 2019 Feb 28;36(2):121-128. doi: 10.4274/balkanmedj.galenos.2018.2018.0852. Epub 2018 Nov 12.

  PMID: 30417831 RESULT

• Orsolya M, Attila-Zoltan M, Gherman V, Zaharie F, Bolboaca S, Chira C, Bodolea C, Tomuleasa C, Irimie A, Coman I, Ionescu D. The effect of anaesthetic management on neutrophil gelatinase associated lipocalin (NGAL) levels after robotic surgical oncology. J BUON. 2015 Jan-Feb;20(1):317-24.

  PMID: 25778333 RESULT

• Buonafine M, Martinez-Martinez E, Jaisser F. More than a simple biomarker: the role of NGAL in cardiovascular and renal diseases. Clin Sci (Lond). 2018 May 8;132(9):909-923. doi: 10.1042/CS20171592. Print 2018 May 16.

  PMID: 29739822 RESULT

• Shavit L, Dolgoker I, Ivgi H, Assous M, Slotki I. Neutrophil gelatinase-associated lipocalin as a predictor of complications and mortality in patients undergoing non-cardiac major surgery. Kidney Blood Press Res. 2011;34(2):116-24. doi: 10.1159/000323897. Epub 2011 Feb 11.

  PMID: 21311195 RESULT

• Akpinar C, Dogan O, Kubilay E, Gokce MI, Suer E, Gulpinar O, Baltaci S. The evaluation of acute kidney injury due to ischemia by urinary neutrophil gelatinase-induced lipocalin (uNGAL) measurement in patients who underwent partial nephrectomy. Int Urol Nephrol. 2021 Mar;53(3):393-400. doi: 10.1007/s11255-020-02660-2. Epub 2020 Sep 26.

  PMID: 32980930 RESULT

• Colamonico O, Cardo G, Ceci E, Scarcia M, Zazzara M, Dassira M, Porreca A, Ludovico GM. The variation of selective uNGAL levels after robot-assisted partial nephrectomy: Early results of a prospective single center study. Arch Ital Urol Androl. 2019 Jul 2;91(2). doi: 10.4081/aiua.2019.2.74.

  PMID: 31266271 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Preoperative and perioperative blood samples will be taken at the 2nd and 6th hours to determine NGAL values. Blood samples will also be taken for urea, creatinine, and GFR values.

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

Central Study Contacts

Aslı Demircioğlu

CONTACT

5383118012; asli.demircioglu92@gmail.com

Zeynep Nur Akçaboy

CONTACT

5054514665; zakcaboy@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2024
• First Posted: February 23, 2024
• Study Start: October 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: April 1, 2024
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)