Geriatric Presentation of Urinary Tract InfectionNCT05030727
Intraoperative NGAL Level in Geriatric Patients Undergoing Laparotomy
A study testing record of pNGAL in people with Geriatric Presentation of Urinary Tract Infection and Acute Kidney Injury, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to detect early renal dysfunction that may occur during the surgical procedure in geriatric patients who will undergo laparotomy surgery. In elderly patients undergoing surgery, accurate estimation of organ function is often not possible. Read more about this study
- Who is it for?
- Ages 64 to 90 years
- Conditions the study is for
- Geriatric Presentation of Urinary Tract Infection, Acute Kidney Injury
- What is being tested?
- record of pNGAL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Mar 2021to 10 Sep 2021
- Phase
- Interventional
- 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 64 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 64 years and older (ASA I-II-III class), who were to undergo major abdominal laparotomy surgery, whose consent forms were obtained, were included in the study.
Who cannot join
- Patients with severe cardiac and respiratory distress, liver and kidney failure, and those who did not consent to the study will not be accepted into the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comprehensive Assessments of Intraoperative NGAL Level in Geriatric Patients Undergoing Laparotomy'
The aim of this study is to detect early renal dysfunction that may occur during the surgical procedure in geriatric patients who will undergo laparotomy surgery.
In elderly patients undergoing surgery, accurate estimation of organ function is often not possible. Accurate measurement of kidney function is vital to the routine care of patients. Determining kidney function status can predict the progression of kidney disease and prevent toxic drug levels in the body.The biochemical marker creatinine, found in serum and urine, is widely used in the estimation of GFR. Although glomerular filtration rate decreases with aging, creatinine also decreases in the elderly due to muscle loss. Even moderately elevated blood creatinine may be indicative of severe kidney failure. Creatinine clearance (CrCl) is the volume of blood plasma cleared of creatinine per unit time. It is a fast and cost-effective method for measuring kidney function. Creatine is a breakdown product of creatine phosphate found in skeletal muscle. Its production in the body depends on muscle mass. The CrCl ratio approximates the GFR calculation as it freely filters the glomerular creatine.
High serum creatinine levels and decreased CrCl ratio are usually indicators of abnormal kidney function.One of the markers of acute kidney injury is to look at plasma NGAL values. Plasma NGAL (neutrophil gelatinase associated lipocalin) increases in response to damaged kidney status and can predict acute kidney injury as an early marker. Data on investigating plasma NGAL values as a predictive biomarker of acute kidney injury in patients undergoing non-cardiovascular surgery are very limited NGAL is produced from the epithelium of kidneys, lungs, colon, liver, adipose tissue, and inflammatory cells. NGAL is elevated in serum and urine after acute tubular injury, making it possible to diagnose kidney damage within 2 hours of injury. However, the increase of other traditional markers such as creatinine may be delayed for up to 48 hours after acute kidney injury.To determine the roles of primary outcome serum creatinine, creatinine clearance rates and plasma NGAL levels in the diagnosis of acute renal failure
Read the detailed description
This study will be performed on 60 patients aged 64 years and older who will undergo major abdominal laparotomy surgery in Marmara University Pendik E.A.H Operating Room, whose informed consent forms have been obtained from the patients. Patients with severe cardiac and respiratory distress, liver and kidney failure, and those who did not consent to the study will not be accepted into the study.
Preoperative (0.hour baseline), postoperative 24.,48. BUN, Creatinine, Lactate values in the blood of the patients at 1 hour, and for plasma NGAL, blood samples will be taken at the preoperative, postoperative 6th and 24th hours. And the results will be recorded.
No group will be formed in the study, which includes a total of 60 patients. All patients will be anesthetized by induction of anesthesia (2 mg/kg propfol/ 1-2 mcgr/kg remifentanil/ 0.6 mg/kg rocuronium), and intraoperative inhaler Desflurane + intravenous Remifentanil will be used to provide maintenance anesthesia. Patients will be given intravenous fluids of 4-8 ml/kg/hr with PVI monitoring, if necessary, without fluid restriction.
Statistically is acceptable for the area under the ROC curve to be above 0.700. It has been determined that we need a minimum of 60 people in order to show that an area with a minimum level of 0.700 is statistically significant.
the aim of our study is to detect early renal dysfunction that may occur during the surgical procedure in geriatric patients who will undergo laparotomy surgery.
In elderly patients undergoing surgery, accurate estimation of organ function is often not possible. Accurate measurement of kidney function is vital to the routine care of patients. Determining kidney function status can predict the progression of kidney disease and prevent toxic drug levels in the body. Glomerular filtration rate measurement includes the injection of inulin and its clearance by the kidneys. However, the use of inulin is invasive, time consuming and an expensive procedure. Alternatively, the biochemical marker creatinine, found in serum and urine, is widely used in the estimation of GFR. Although glomerular filtration rate decreases with aging, creatinine also decreases in the elderly due to muscle loss. Even moderately elevated blood creatinine may be indicative of severe kidney failure. Creatinine clearance (CrCl) is the volume of blood plasma cleared of creatinine per unit time. It is a fast and cost-effective method for measuring kidney function. Creatine is a breakdown product of creatine phosphate found in skeletal muscle. Its production in the body depends on muscle mass. The CrCl ratio approximates the GFR calculation as it freely filters the glomerular creatinine. However, it is also secreted by the peritubular capillaries, causing CrCl to overestimate GFR by about 10% to 20%. Despite the marginal error, it was an accepted method for measuring GFR due to the ease of measurement of CrCl. Creatinine clearance can be estimated using serum creatinine levels. The Cockcroft-Gault (C-G) formula uses the patient's weight (kg) and gender to estimate CrCl (mg/dL). To correct for lower CrCl in females, the resulting CrCl is multiplied by 0.85 if the patient is female. The C-G formula is age dependent as the main predictor for CrCl.
eCCr = (140 - age) x (kg) x [0.85 if female] / 72 x [Serum creatinine (mg/dL)] High serum creatinine levels and decreased CrCl ratio are usually indicators of abnormal kidney function.
One of the markers of acute kidney injury is to look at plasma NGAL values. Plasma NGAL (neutrophil gelatinase associated lipocalin) increases in response to damaged kidney status and can predict acute kidney injury as an early marker. Data on investigating plasma NGAL values as a predictive biomarker of acute kidney injury in patients undergoing non-cardiovascular surgery are very limited NGAL is produced from the epithelium of kidneys, lungs, colon, liver, adipose tissue, and inflammatory cells. NGAL is elevated in serum and urine after acute tubular injury, making it possible to diagnose kidney damage within 2 hours of injury. However, the increase of other traditional markers such as creatinine may be delayed for up to 48 hours after acute kidney injury.
To determine the roles of primary outcome serum creatinine, creatinine clearance rates and plasma NGAL levels in the diagnosis of acute renal failure
- Being tested
- record of pNGAL
- 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.
record of pNGALDiagnostic test
Preoperative (0.hour baseline), postoperative 24.,48. BUN, Creatinine, Lactate values in the blood of the patients at 1 hour, and for plasma NGAL, blood samples will be taken at the preoperative, postoperative 6th and 24th hours. And the results will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Evaluation of intraoperative NGAL levels in terms of acute kidney injury in geriatric patients | Other | only one group Receives: Diagnostic Test: record of pNGAL |
What is being measured
The primary outcome is the main question the study is designed to answer.
the roles of plasma NGAL levels in acute renal failure.
roles of plasma NGAL levels in the diagnosis of acute renal failure.
Measured: first 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start5 Mar 2021
- Primary completion2 Sep 2021
- Study completion10 Sep 2021
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 Geriatric Presentation of Urinary Tract InfectionStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meliha Orhon, Marmara University
- Investigators
- MELIHA ORHON ERGUN, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05030727
- Sponsor's protocol ID
- 09.2021.392
- Status last verified
- Oct 2021
- First submitted
- 4 Jun 2021
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Orhon Ergun M, Zengin SU, Mustafayeva A, Umuroglu T. Neutrophil gelatinase associated lipocalin in predicting postoperative acute kidney injury in elderly. Ir J Med Sci. 2022 Jun;191(3):1297-1303. doi: 10.1007/s11845-021-02865-z. Epub 2021 Nov 25.
PubMed 34822023
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Assessments of Intraoperative NGAL Level in Geriatric Patients Undergoing Laparotomy'
- ClinicalTrials.gov ID
- NCT05030727
- Acronym / sponsor ID
- 09.2021.392
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 2 Sep 2021 (actual)
- Study completion
- 10 Sep 2021 (actual)
- First posted
- 1 Sep 2021 (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 aim of this study is to detect early renal dysfunction that may occur during the surgical procedure in geriatric patients who will undergo laparotomy surgery.
In elderly patients undergoing surgery, accurate estimation of organ function is often not possible. Accurate measurement of kidney function is vital to the routine care of patients. Determining kidney function status can predict the progression of kidney disease and prevent toxic drug levels in the body.The biochemical marker creatinine, found in serum and urine, is widely used in the estimation of GFR. Although glomerular filtration rate decreases with aging, creatinine also decreases in the elderly due to muscle loss. Even moderately elevated blood creatinine may be indicative of severe kidney failure. Creatinine clearance (CrCl) is the volume of blood plasma cleared of creatinine per unit time. It is a fast and cost-effective method for measuring kidney function. Creatine is a breakdown product of creatine phosphate found in skeletal muscle. Its production in the body depends on muscle mass. The CrCl ratio approximates the GFR calculation as it freely filters the glomerular creatine.
High serum creatinine levels and decreased CrCl ratio are usually indicators of abnormal kidney function.One of the markers of acute kidney injury is to look at plasma NGAL values. Plasma NGAL (neutrophil gelatinase associated lipocalin) increases in response to damaged kidney status and can predict acute kidney injury as an early marker. Data on investigating plasma NGAL values as a predictive biomarker of acute kidney injury in patients undergoing non-cardiovascular surgery are very limited NGAL is produced from the epithelium of kidneys, lungs, colon, liver, adipose tissue, and inflammatory cells. NGAL is elevated in serum and urine after acute tubular injury, making it possible to diagnose kidney damage within 2 hours of injury. However, the increase of other traditional markers such as creatinine may be delayed for up to 48 hours after acute kidney injury.To determine the roles of primary outcome serum creatinine, creatinine clearance rates and plasma NGAL levels in the diagnosis of acute renal failure
Detailed description
This study will be performed on 60 patients aged 64 years and older who will undergo major abdominal laparotomy surgery in Marmara University Pendik E.A.H Operating Room, whose informed consent forms have been obtained from the patients. Patients with severe cardiac and respiratory distress, liver and kidney failure, and those who did not consent to the study will not be accepted into the study.
Preoperative (0.hour baseline), postoperative 24.,48. BUN, Creatinine, Lactate values in the blood of the patients at 1 hour, and for plasma NGAL, blood samples will be taken at the preoperative, postoperative 6th and 24th hours. And the results will be recorded.
No group will be formed in the study, which includes a total of 60 patients. All patients will be anesthetized by induction of anesthesia (2 mg/kg propfol/ 1-2 mcgr/kg remifentanil/ 0.6 mg/kg rocuronium), and intraoperative inhaler Desflurane + intravenous Remifentanil will be used to provide maintenance anesthesia. Patients will be given intravenous fluids of 4-8 ml/kg/hr with PVI monitoring, if necessary, without fluid restriction.
Statistically is acceptable for the area under the ROC curve to be above 0.700. It has been determined that we need a minimum of 60 people in order to show that an area with a minimum level of 0.700 is statistically significant.
the aim of our study is to detect early renal dysfunction that may occur during the surgical procedure in geriatric patients who will undergo laparotomy surgery.
In elderly patients undergoing surgery, accurate estimation of organ function is often not possible. Accurate measurement of kidney function is vital to the routine care of patients. Determining kidney function status can predict the progression of kidney disease and prevent toxic drug levels in the body. Glomerular filtration rate measurement includes the injection of inulin and its clearance by the kidneys. However, the use of inulin is invasive, time consuming and an expensive procedure. Alternatively, the biochemical marker creatinine, found in serum and urine, is widely used in the estimation of GFR. Although glomerular filtration rate decreases with aging, creatinine also decreases in the elderly due to muscle loss. Even moderately elevated blood creatinine may be indicative of severe kidney failure. Creatinine clearance (CrCl) is the volume of blood plasma cleared of creatinine per unit time. It is a fast and cost-effective method for measuring kidney function. Creatine is a breakdown product of creatine phosphate found in skeletal muscle. Its production in the body depends on muscle mass. The CrCl ratio approximates the GFR calculation as it freely filters the glomerular creatinine. However, it is also secreted by the peritubular capillaries, causing CrCl to overestimate GFR by about 10% to 20%. Despite the marginal error, it was an accepted method for measuring GFR due to the ease of measurement of CrCl. Creatinine clearance can be estimated using serum creatinine levels. The Cockcroft-Gault (C-G) formula uses the patient's weight (kg) and gender to estimate CrCl (mg/dL). To correct for lower CrCl in females, the resulting CrCl is multiplied by 0.85 if the patient is female. The C-G formula is age dependent as the main predictor for CrCl.
eCCr = (140 - age) x (kg) x [0.85 if female] / 72 x [Serum creatinine (mg/dL)] High serum creatinine levels and decreased CrCl ratio are usually indicators of abnormal kidney function.
One of the markers of acute kidney injury is to look at plasma NGAL values. Plasma NGAL (neutrophil gelatinase associated lipocalin) increases in response to damaged kidney status and can predict acute kidney injury as an early marker. Data on investigating plasma NGAL values as a predictive biomarker of acute kidney injury in patients undergoing non-cardiovascular surgery are very limited NGAL is produced from the epithelium of kidneys, lungs, colon, liver, adipose tissue, and inflammatory cells. NGAL is elevated in serum and urine after acute tubular injury, making it possible to diagnose kidney damage within 2 hours of injury. However, the increase of other traditional markers such as creatinine may be delayed for up to 48 hours after acute kidney injury.
To determine the roles of primary outcome serum creatinine, creatinine clearance rates and plasma NGAL levels in the diagnosis of acute renal failure
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluation of intraoperative NGAL levels in terms of acute kidney injury in geriatric patients | Other | Diagnostic Test: record of pNGALonly one group |
Who may qualify
- Ages
- 64 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 64 years and older (ASA I-II-III class), who were to undergo major abdominal laparotomy surgery, whose consent forms were obtained, were included in the study.
Key exclusion criteria (1 listed)
- Patients with severe cardiac and respiratory distress, liver and kidney failure, and those who did not consent to the study will not be accepted into the study.
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 |
|---|---|---|
| record of pNGALPreoperative (0.hour baseline), postoperative 24.,48. BUN, Creatinine, Lactate values in the blood of the patients at 1 hour, and for plasma NGAL, blood samples will be taken at the preoperative, postoperative 6th and 24th hours. And the results will be recorded. | Diagnostic test | Evaluation of intraoperative NGAL levels in terms of acute kidney injury in geriatric patients |
Primary outcome
the roles of plasma NGAL levels in acute renal failure.
Time frame: first 24 hours after surgery
roles of plasma NGAL levels in the diagnosis of acute renal failure.
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 8 Oct 2021.
- Derived from this study: PubMed 34822023Orhon Ergun M, Zengin SU, Mustafayeva A, Umuroglu T. Neutrophil gelatinase associated lipocalin in predicting postoperative acute kidney injury in elderly. Ir J Med Sci. 2022 Jun;191(3):1297-1303. doi: 10.1007/s11845-021-02865-z. Epub 2021 Nov 25.
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.
MELIHA ORHON ERGUN principal investigator
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing record of pNGAL in people with Geriatric Presentation of Urinary Tract Infection and Acute Kidney Injury, run by Marmara University 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 1 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 8 Oct 2021. 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?
the roles of plasma NGAL levels in acute renal failure. (time frame: first 24 hours after surgery). 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 NCT05030727, 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 8 Oct 2021.