ProstatectomyNCT06274125
Evaluation of Kidney Damage Using NGAL Measurements
An observational study of Prostatectomy and Neutrophil Gelatinase-Associated Lipocalin, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostatectomy, Neutrophil Gelatinase-Associated Lipocalin, Kidney Function Tests
- What is being tested?
- Robotic-Assisted Laparoscopic Radical Prostatectomy
- Type of treatment
- Surgery or procedure
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- -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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Bilkent City Hospital
Ankara, Çankaya, 06530
About this study
Official title: The Assessment of Kidney Damage Using NGAL Measurements in Patients Undergoing Robotic Radical Prostatectomy
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.
Read the 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.
- Being tested
- Robotic-Assisted Laparoscopic Radical Prostatectomy
- Keywords
- robotic surgery, Neutrophil Gelatinase-Associated Lipocalin, Acute kidney injury
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic-Assisted Laparoscopic Radical ProstatectomyProcedure or surgery
To evaluate kidney damage in patients undergoing robotic radical prostatectomy, NGAL measurement will be performed.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Robotic-Assisted Laparoscopic Radical Prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: The relationship between intraoperative mean arterial pressure monitoring and NGAL values obtained at 0, 2, and 6 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start1 Oct 2023
- Primary completionMar 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for ProstatectomyStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06274125
- Sponsor's protocol ID
- AslıDemircioglu1
- Status last verified
- Feb 2024
- First submitted
- 16 Feb 2024
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30417831Orsolya 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.
PubMed 25778333Buonafine 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.
PubMed 29739822Shavit 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.
PubMed 21311195Akpinar 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.
PubMed 32980930Colamonico 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.
PubMed 31266271
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Assessment of Kidney Damage Using NGAL Measurements in Patients Undergoing Robotic Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT06274125
- Acronym / sponsor ID
- AslıDemircioglu1
- Keywords
- robotic surgery, Neutrophil Gelatinase-Associated Lipocalin, Acute kidney injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 23 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NGAL measurement for evaluating kidney damage in patients undergoing robotic radical prostatectomy. | – | Procedure: Robotic-Assisted Laparoscopic Radical ProstatectomyFor 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- -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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic-Assisted Laparoscopic Radical ProstatectomyTo evaluate kidney damage in patients undergoing robotic radical prostatectomy, NGAL measurement will be performed. | Procedure or surgery | NGAL measurement for evaluating kidney damage in patients undergoing robotic radical prostatectomy. |
Primary outcome
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.
Time frame: 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.
3 secondary outcomes
The relationship between demographic parameters such as age, BMI, comorbidities, and ASA classification will be evaluated in relation to the development of AKI.
Time frame: 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.
Time frame: 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.
Time frame: The relationship between intraoperative mean arterial pressure monitoring and NGAL values obtained at 0, 2, and 6 hours.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Results publication: PubMed 30417831Savran 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.
- Results publication: PubMed 25778333Orsolya 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.
- Results publication: PubMed 29739822Buonafine 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.
- Results publication: PubMed 21311195Shavit 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.
- Results publication: PubMed 32980930Akpinar 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.
- Results publication: PubMed 31266271Colamonico 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatectomy and Neutrophil Gelatinase-Associated Lipocalin, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aslı Demircioğlu (5383118012 ext. +90, asli.demircioglu92@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06274125, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.