Acute Kidney InjuryNCT05721638
Neutrophil Gelatinase-associated Lipocalin in Major Abdominal Surgery
An observational study of Acute Kidney Injury, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Acute kidney injury (AKI) after major surgery is a well-known complication. The incidence of AKI after major surgery ranges from 13% to 50%. The morbidity and mortality rates increase in patients with AKI due to the treatments applied and the prolonged hospital stay. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Neutrophil gelatinase-associated lipocalin
- How many people
- 43 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 31 Dec 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who will undergo major abdominal surgery in Antalya Training and Research Hospital.
Who may be able to join
- ASA I-III,
- Patients undergoing elective major abdominal surgery
Who cannot join
- Chronic renal failure,
- Using nephrotoxic drugs,
- Patients with a history of kidney transplantation or nephrectomy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Antalya Training and Research Hospital
Antalya
About this study
Official title: Efficacy of Serum and Urinary Neutrophil Gelatinase-associated Lipocalin in the Early Detection of Acute Kidney Injury After Major Abdominal Surgery
Acute kidney injury (AKI) after major surgery is a well-known complication. The incidence of AKI after major surgery ranges from 13% to 50%. The morbidity and mortality rates increase in patients with AKI due to the treatments applied and the prolonged hospital stay. In addition, as a result of all these processes, hospital costs increase and burden the health systems.
Classifications such as Acute Kidney Injury Network (AKIN) or Kidney Disease Improving Global Outcomes (KDIGO) are used in the diagnosis of AKI. In these classifications, evaluation is made based on kidney damage, serum creatinine (Scr), and urine output. However, Scr; is affected by factors such as age, gender, diet, muscle mass, and medication. In addition, in healthy individuals in terms of kidney reserve, a loss of up to 50% in nephrons is tolerated by the body and there is no change in Scr values. Therefore, the onset of the increase in Scr values occurs 48-72 hours after kidney damage. This situation causes delays in the treatments applied and increases morbidity and mortality rates.
Read more
For these reasons, interest in biomarkers used in the early diagnosis of AKI has increased in recent years. Neutrophil gelatinase-associated lipocalin (NGAL) is a 25 KDa, neutrophil-derived molecule from the lipocalin family. It is also secreted in small amounts from kidney, prostate, and respiratory tract epithelial cells. After ischemic and nephrotoxic acute tubular necrosis, NGAL levels peak at the 3rd hour and remain elevated for approximately 24 hours. In patients who do not progress to AKI, NGAL levels begin to decrease in the 1st hour after injury.
When the current literature is examined, scientific studies on NGAL have mostly been carried out on cardiovascular surgery cases to date. There are very few studies evaluating NGAL levels in patients who develop AKI after major abdominal surgery. These few studies evaluated either serum NGAL or urinary NGAL levels. In this study, both serum NGAL and urinary NGAL will be measured simultaneously to detect AKI that may develop in patients undergoing major abdominal surgery.
- Conditions
- Acute Kidney Injury
- Being tested
- Neutrophil gelatinase-associated lipocalin
- Keywords
- Acute Kidney Injury, Neutrophil gelatinase-associated lipocalin, Major abdominal surgery
- 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.
Neutrophil gelatinase-associated lipocalinDiagnostic test
Neutrophil gelatinase-associated lipocalin (NGAL) is a 25 KDa, neutrophil-derived molecule from the lipocalin family. It is also secreted in small amounts from kidney, prostate, and respiratory tract epithelial cells. After ischemic and nephrotoxic acute tubular necrosis, NGAL levels peak at the 3rd hour and remain elevated for approximately 24 hours. In patients who do not progress to AKI, NGAL levels begin to decrease as of the 1st hour after injury.
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma NGAL Level
From patients undergoing major abdominal surgery, a blood sample will be taken at Postop 4th Hour for serum NGAL analysis.
Measured: Postoperative 4th hour
Urine NGAL level
Urine samples will be collected from patients undergoing major abdominal surgery at the 4th postoperative hour for urine NGAL analysis.
Measured: Postoperative 4th hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start1 Jun 2023
- Primary completion30 Nov 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Erhan Ozyurt, Antalya Training and Research Hospital
- Investigators
- Erhan OZYURT, MD, Principal investigator, Antalya Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05721638
- Sponsor's protocol ID
- Erhanter01
- Status last verified
- Jan 2024
- First submitted
- 1 Feb 2023
- Last updated
- 31 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pan HC, Yang SY, Chiou TT, Shiao CC, Wu CH, Huang CT, Wang TJ, Chen JY, Liao HW, Chen SY, Huang TM, Yang YF, Lin HY, Chan MJ, Sun CY, Chen YT, Chen YC, Wu VC. Comparative accuracy of biomarkers for the prediction of hospital-acquired acute kidney injury: a systematic review and meta-analysis. Crit Care. 2022 Nov 12;26(1):349. doi: 10.1186/s13054-022-04223-6.
PubMed 36371256
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Serum and Urinary Neutrophil Gelatinase-associated Lipocalin in the Early Detection of Acute Kidney Injury After Major Abdominal Surgery
- ClinicalTrials.gov ID
- NCT05721638
- Acronym / sponsor ID
- Erhanter01
- Conditions
- Acute Kidney Injury
- Keywords
- Acute Kidney Injury, Neutrophil gelatinase-associated lipocalin, Major abdominal surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 10 Feb 2023 (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.
Acute kidney injury (AKI) after major surgery is a well-known complication. The incidence of AKI after major surgery ranges from 13% to 50%. The morbidity and mortality rates increase in patients with AKI due to the treatments applied and the prolonged hospital stay. In addition, as a result of all these processes, hospital costs increase and burden the health systems.
Classifications such as Acute Kidney Injury Network (AKIN) or Kidney Disease Improving Global Outcomes (KDIGO) are used in the diagnosis of AKI. In these classifications, evaluation is made based on kidney damage, serum creatinine (Scr), and urine output. However, Scr; is affected by factors such as age, gender, diet, muscle mass, and medication. In addition, in healthy individuals in terms of kidney reserve, a loss of up to 50% in nephrons is tolerated by the body and there is no change in Scr values. Therefore, the onset of the increase in Scr values occurs 48-72 hours after kidney damage. This situation causes delays in the treatments applied and increases morbidity and mortality rates.
For these reasons, interest in biomarkers used in the early diagnosis of AKI has increased in recent years. Neutrophil gelatinase-associated lipocalin (NGAL) is a 25 KDa, neutrophil-derived molecule from the lipocalin family. It is also secreted in small amounts from kidney, prostate, and respiratory tract epithelial cells. After ischemic and nephrotoxic acute tubular necrosis, NGAL levels peak at the 3rd hour and remain elevated for approximately 24 hours. In patients who do not progress to AKI, NGAL levels begin to decrease in the 1st hour after injury.
When the current literature is examined, scientific studies on NGAL have mostly been carried out on cardiovascular surgery cases to date. There are very few studies evaluating NGAL levels in patients who develop AKI after major abdominal surgery. These few studies evaluated either serum NGAL or urinary NGAL levels. In this study, both serum NGAL and urinary NGAL will be measured simultaneously to detect AKI that may develop in patients undergoing major abdominal surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who will undergo major abdominal surgery in Antalya Training and Research Hospital.
Key inclusion criteria (2 listed)
- ASA I-III,
- Patients undergoing elective major abdominal surgery
Key exclusion criteria (3 listed)
- Chronic renal failure,
- Using nephrotoxic drugs,
- Patients with a history of kidney transplantation or nephrectomy
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 |
|---|---|---|
| Neutrophil gelatinase-associated lipocalinNeutrophil gelatinase-associated lipocalin (NGAL) is a 25 KDa, neutrophil-derived molecule from the lipocalin family. It is also secreted in small amounts from kidney, prostate, and respiratory tract epithelial cells. After ischemic and nephrotoxic acute tubular necrosis, NGAL levels peak at the 3rd hour and remain elevated for approximately 24 hours. In patients who do not progress to AKI, NGAL levels begin to decrease as of the 1st hour after injury. | Diagnostic test | – |
Primary outcome
Plasma NGAL Level
Time frame: Postoperative 4th hour
From patients undergoing major abdominal surgery, a blood sample will be taken at Postop 4th Hour for serum NGAL analysis.
Urine NGAL level
Time frame: Postoperative 4th hour
Urine samples will be collected from patients undergoing major abdominal surgery at the 4th postoperative hour for urine NGAL analysis.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Background: PubMed 36371256Pan HC, Yang SY, Chiou TT, Shiao CC, Wu CH, Huang CT, Wang TJ, Chen JY, Liao HW, Chen SY, Huang TM, Yang YF, Lin HY, Chan MJ, Sun CY, Chen YT, Chen YC, Wu VC. Comparative accuracy of biomarkers for the prediction of hospital-acquired acute kidney injury: a systematic review and meta-analysis. Crit Care. 2022 Nov 12;26(1):349. doi: 10.1186/s13054-022-04223-6.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Kidney Injury
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Acute Kidney Injury, Hypotension (MeSH: D007022)
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.
Erhan OZYURT, MD principal investigator
Antalya Training and Research Hospital
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 Acute Kidney Injury, run by Antalya Training and Research Hospital 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 31 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma NGAL Level (time frame: Postoperative 4th hour). The study lists 2 primary outcomes in all. 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 NCT05721638, which also lists 1 linked publication.
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 31 Jan 2024.