Evaluation of Kidney Damage Using NGAL Measurements

NCT ID: NCT06274125

Last Updated: 2024-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-04-30

Brief Summary

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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

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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.

Conditions

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Prostatectomy Neutrophil Gelatinase-Associated Lipocalin Kidney Function Tests

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Robotic-Assisted Laparoscopic Radical Prostatectomy

Intervention Type PROCEDURE

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

Interventions

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Robotic-Assisted Laparoscopic Radical Prostatectomy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Ankara City Hospital Bilkent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ankara Bilkent City Hospital

Ankara, Çankaya, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Aslı Demircioğlu

Role: CONTACT

5383118012 ext. +90

Zeynep Nur Akçaboy

Role: CONTACT

5054514665 ext. +90

References

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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.

Reference Type RESULT
PMID: 30417831 (View on PubMed)

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.

Reference Type RESULT
PMID: 25778333 (View on PubMed)

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.

Reference Type RESULT
PMID: 29739822 (View on PubMed)

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.

Reference Type RESULT
PMID: 21311195 (View on PubMed)

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.

Reference Type RESULT
PMID: 32980930 (View on PubMed)

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.

Reference Type RESULT
PMID: 31266271 (View on PubMed)

Other Identifiers

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AslıDemircioglu1

Identifier Type: -

Identifier Source: org_study_id

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