SepsisNGALNCT05374759
NGAL and Renal Resistive Index in the Diagnosis and Prognosis of Sepsis-associated AKI
An observational study of Sepsis and Acute Kidney Injury, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
AKI develops frequently in patients hospitalized in the intensive care unit, and the biggest risk factor is sepsis. Creatine, which is traditionally used in the diagnosis of AKI, is affected by many factors, causes the diagnosis to be delayed, and its effect in showing the prognosis is limited. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sepsis, Acute Kidney Injury
- What is being tested?
- neutrophil gelatinase-associated lipocalin and renal resistive index
- How many people
- 101 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 May 2022to 11 Dec 2022
- 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 70 years
- All sexes
- Adult, Older adult
Study population: patients with sepsis in ICU.
Who may be able to join
- sepsis
- septic shock
Who cannot join
- Weak abdominal echogenicity age < 18, other conditions causing shock (hypovolemic, cardiogenic, neurogenic), having a life expectancy of less than 24 hours, pregnancy, vasospastic disease, intraperitoneal pressure > 15 mm Hg, obstructive renal failure or suspected, presence of arrhythmia, presence of renal artery stenosis, kidney transplant patients presence of kidney tumor patients receiving dialysis treatment, solitary kidney and other kidney abnormalities, presence of coronary artery disease, presence of acute mesenteric ischemia, Those who have been using drugs that inhibit angiotensin converting enzyme (ACE) and angiotensin receptor blockers for the last 48 hours, Patients with severe acute or chronic renal failure defined as glomerular filtration rate (GFR) < 30 ml/min/1.73 m2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of the Value of Neutrophil Gelatinase-associated Lipocalin and Renal Resistive Index in the Diagnosis and Prognosis of Sepsis-associated Acute Kidney Injury
AKI develops frequently in patients hospitalized in the intensive care unit, and the biggest risk factor is sepsis. Creatine, which is traditionally used in the diagnosis of AKI, is affected by many factors, causes the diagnosis to be delayed, and its effect in showing the prognosis is limited. Therefore, there is a need to search for new parameters for early diagnosis and prediction of prognosis. Although many biomarkers studied in blood and urine have been reported in the literature, NGAL has been the most emphasized in terms of both diagnosis and prognosis. Although there are publications on the use of the renal resistive index in the diagnosis in new studies, the place of RRI in the diagnosis has not been determined exactly, and its effect on the prognosis has not been studied. In our study, renal resistive index will be measured by renal ultrasonography at the bedside in patients with sepsis at the time of diagnosis, and NGAL will be studied from the blood of the patients, and their values will be compared in terms of detecting patients with AKI in sepsis and showing prognosis. In summary, if the renal resistive index is superior to serum NGAL and parameters such as creatinine level in showing the diagnosis and prognosis of AKI; Early planning of the patient's treatment with a bedside and non-invasive method will also reduce the cost, considering that ultrasonography is now indispensable for all intensive care units.
Read the detailed description
In this prospective cross-sectional study, the diagnosis of sepsis (infection+SOFA≥2) and septic shock (lactate>2 in patients with sepsis and vasopressor requirement to keep mean arterial pressure above 65mmHg) were included in our 26-bed mixed intensive care unit, aged 18-70 years. Patients receiving according to sepsis-3 criteria will be included.
Poor abdominal echogenicity, age < 18 years, other conditions causing shock (hypovolemic, cardiogenic, neurogenic), life expectancy shorter than 24 hours, pregnancy, vasospastic disease, intraperitoneal pressure > 15 mm Hg, obstructive renal failure or suspected, presence of arrhythmia , presence of renal artery stenosis, kidney transplant patients, kidney tumor, patients receiving dialysis treatment, single kidney and other kidney abnormalities, presence of coronary artery disease, presence of acute mesenteric ischemia, presence of angiotensin converting enzyme (ACE) inhibition and angiotensin receptor for the last 48 hours Those who use blocking drugs, those with severe acute or chronic renal failure defined as glomerular filtration rate (GFR) < 30 ml/min/1.73m2 will be excluded from the study.
After the patients were diagnosed with sepsis/septic shock, in accordance with the Surviving sepsis 2021 guideline; cultures will be sent and antibiotic, fluid and, if necessary, vasopressor therapy will be started. Standard monitoring of the patients (heart rate, mean arterial pressure, peripheral oxygen saturation, temperature, capillary refill time, perfusion index) will be performed. To determine whether patients develop AKI in the first five days of ICU admission, both creatinine and urine output will be monitored daily according to the KDIGO criteria during the first five days of ICU admission. Patients who developed AKI in our follow-up period after being diagnosed with sepsis/septic shock will be included in Group AKI. Group Control (GK) will be formed from patients who do not develop AKI.
Blood collection for RRI measurement and Serum NGAL level for the study; patients will be diagnosed with sepsis and septic shock, and bundle therapy will be applied for one hour, and after hemodynamic stabilization is achieved (within the first 24 hours). Day 5 RRI measurement and serum NGAL level measurement will be repeated to evaluate the prognosis in patients in group AKI.
The renal resistive index (RRI) will be measured by ultrasound-Doppler. After imaging the kidney in ultrasound mode and checking for renal abnormalities, an arcuate or interlobar artery will be localized and three consecutive Doppler measurements at different points in kidney positions (high, medium, and low) will be performed 3 times in each kidney, resulting in a total of 9 RRI values in each kidney. . The median value of each kidney will be used and the average of the 3 median values of each kidney will be taken.
For serum NGAL level, approximately 10 ml of blood samples taken from the peripheral vein line will be centrifuged at 1500 rpm for 5 minutes and stored at -80 oC.
Patients' age, gender, weight, height, body mass index, concomitant diseases (eg, diabetes mellitus, hypertension, heart failure, COPD, cancer, anemia, intoxications, trauma), source of infection, procalcitonin, c-reactive protein (CRP) ), lactate, circulatory markers, medications (diuretic, vasopressor, inotropic agent, antimicrobial, insulin, colloid, albumin use, blood and blood product transfusion), recent use of contrast media, fluid balance, need for dialysis or hemodiafiltration, mechanical ventilation therapy need, stage of the AKI group according to KDIGO, Acute Physiology and Chronic Health Evaluation (APACHE II) score, Sequential Organ Failure Assesment (SOFA) score, length of hospital stay, renal function before discharge or mortality, and 28-day mortality will be recorded.
- Conditions
- Sepsis, Acute Kidney Injury
- Being tested
- neutrophil gelatinase-associated lipocalin, renal resistive index
- Medical subject headings
- Sepsis, 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
When the patient is diagnosed with sepsis and on the 3rd day of the follow-up, blood samples will be taken and NGAL levels will measured.
renal resistive indexDiagnostic test
When the patient is diagnosed with sepsis and on the 3rd day of the follow-up, renal resistive index will measure and record.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients with sepsis who develop AKI Receives: Diagnostic Test: neutrophil gelatinase-associated lipocalin; Diagnostic Test: renal resistive index | |
| Group 2 | Patients with sepsis who do not develop AKI Receives: Diagnostic Test: neutrophil gelatinase-associated lipocalin; Diagnostic Test: renal resistive index |
What is being measured
The primary outcome is the main question the study is designed to answer.
NGAL
Blood NGAL
Measured: at diagnosis
NGAL
Blood NGAL
Measured: at the third days
Renal resistive index
renal resistive index guided ultrasound
Measured: at diagnosis
Renal resistive index
renal resistive index guided ultrasound
Measured: at the third days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study start11 May 2022
- Primary completion11 Nov 2022
- Study completion11 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Inonu 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Belin Ozer, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05374759
- Sponsor's protocol ID
- AOzer3
- Acronym
- NGAL
- Status last verified
- Nov 2023
- First submitted
- 29 Apr 2022
- Last updated
- 3 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Faubel S, Patel NU, Lockhart ME, Cadnapaphornchai MA. Renal relevant radiology: use of ultrasonography in patients with AKI. Clin J Am Soc Nephrol. 2014 Feb;9(2):382-94. doi: 10.2215/CJN.04840513. Epub 2013 Nov 14.
PubMed 24235286Renberg M, Jonmarker O, Kilhamn N, Rimes-Stigare C, Bell M, Hertzberg D. Renal resistive index is associated with acute kidney injury in COVID-19 patients treated in the intensive care unit. Ultrasound J. 2021 Feb 5;13(1):3. doi: 10.1186/s13089-021-00203-z.
PubMed 33544258Haitsma Mulier JLG, Rozemeijer S, Rottgering JG, Spoelstra-de Man AME, Elbers PWG, Tuinman PR, de Waard MC, Oudemans-van Straaten HM. Renal resistive index as an early predictor and discriminator of acute kidney injury in critically ill patients; A prospective observational cohort study. PLoS One. 2018 Jun 11;13(6):e0197967. doi: 10.1371/journal.pone.0197967. eCollection 2018.
PubMed 29889830
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Value of Neutrophil Gelatinase-associated Lipocalin and Renal Resistive Index in the Diagnosis and Prognosis of Sepsis-associated Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT05374759
- Acronym / sponsor ID
- NGAL / AOzer3
- Conditions
- Sepsis, Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 11 May 2022 (actual)
- Primary completion
- 11 Nov 2022 (actual)
- Study completion
- 11 Dec 2022 (actual)
- First posted
- 16 May 2022 (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.
AKI develops frequently in patients hospitalized in the intensive care unit, and the biggest risk factor is sepsis. Creatine, which is traditionally used in the diagnosis of AKI, is affected by many factors, causes the diagnosis to be delayed, and its effect in showing the prognosis is limited. Therefore, there is a need to search for new parameters for early diagnosis and prediction of prognosis. Although many biomarkers studied in blood and urine have been reported in the literature, NGAL has been the most emphasized in terms of both diagnosis and prognosis. Although there are publications on the use of the renal resistive index in the diagnosis in new studies, the place of RRI in the diagnosis has not been determined exactly, and its effect on the prognosis has not been studied. In our study, renal resistive index will be measured by renal ultrasonography at the bedside in patients with sepsis at the time of diagnosis, and NGAL will be studied from the blood of the patients, and their values will be compared in terms of detecting patients with AKI in sepsis and showing prognosis. In summary, if the renal resistive index is superior to serum NGAL and parameters such as creatinine level in showing the diagnosis and prognosis of AKI; Early planning of the patient's treatment with a bedside and non-invasive method will also reduce the cost, considering that ultrasonography is now indispensable for all intensive care units.
Detailed description
In this prospective cross-sectional study, the diagnosis of sepsis (infection+SOFA≥2) and septic shock (lactate>2 in patients with sepsis and vasopressor requirement to keep mean arterial pressure above 65mmHg) were included in our 26-bed mixed intensive care unit, aged 18-70 years. Patients receiving according to sepsis-3 criteria will be included.
Poor abdominal echogenicity, age < 18 years, other conditions causing shock (hypovolemic, cardiogenic, neurogenic), life expectancy shorter than 24 hours, pregnancy, vasospastic disease, intraperitoneal pressure > 15 mm Hg, obstructive renal failure or suspected, presence of arrhythmia , presence of renal artery stenosis, kidney transplant patients, kidney tumor, patients receiving dialysis treatment, single kidney and other kidney abnormalities, presence of coronary artery disease, presence of acute mesenteric ischemia, presence of angiotensin converting enzyme (ACE) inhibition and angiotensin receptor for the last 48 hours Those who use blocking drugs, those with severe acute or chronic renal failure defined as glomerular filtration rate (GFR) < 30 ml/min/1.73m2 will be excluded from the study.
After the patients were diagnosed with sepsis/septic shock, in accordance with the Surviving sepsis 2021 guideline; cultures will be sent and antibiotic, fluid and, if necessary, vasopressor therapy will be started. Standard monitoring of the patients (heart rate, mean arterial pressure, peripheral oxygen saturation, temperature, capillary refill time, perfusion index) will be performed. To determine whether patients develop AKI in the first five days of ICU admission, both creatinine and urine output will be monitored daily according to the KDIGO criteria during the first five days of ICU admission. Patients who developed AKI in our follow-up period after being diagnosed with sepsis/septic shock will be included in Group AKI. Group Control (GK) will be formed from patients who do not develop AKI.
Blood collection for RRI measurement and Serum NGAL level for the study; patients will be diagnosed with sepsis and septic shock, and bundle therapy will be applied for one hour, and after hemodynamic stabilization is achieved (within the first 24 hours). Day 5 RRI measurement and serum NGAL level measurement will be repeated to evaluate the prognosis in patients in group AKI.
The renal resistive index (RRI) will be measured by ultrasound-Doppler. After imaging the kidney in ultrasound mode and checking for renal abnormalities, an arcuate or interlobar artery will be localized and three consecutive Doppler measurements at different points in kidney positions (high, medium, and low) will be performed 3 times in each kidney, resulting in a total of 9 RRI values in each kidney. . The median value of each kidney will be used and the average of the 3 median values of each kidney will be taken.
For serum NGAL level, approximately 10 ml of blood samples taken from the peripheral vein line will be centrifuged at 1500 rpm for 5 minutes and stored at -80 oC.
Patients' age, gender, weight, height, body mass index, concomitant diseases (eg, diabetes mellitus, hypertension, heart failure, COPD, cancer, anemia, intoxications, trauma), source of infection, procalcitonin, c-reactive protein (CRP) ), lactate, circulatory markers, medications (diuretic, vasopressor, inotropic agent, antimicrobial, insulin, colloid, albumin use, blood and blood product transfusion), recent use of contrast media, fluid balance, need for dialysis or hemodiafiltration, mechanical ventilation therapy need, stage of the AKI group according to KDIGO, Acute Physiology and Chronic Health Evaluation (APACHE II) score, Sequential Organ Failure Assesment (SOFA) score, length of hospital stay, renal function before discharge or mortality, and 28-day mortality will be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Diagnostic Test: neutrophil gelatinase-associated lipocalin, Diagnostic Test: renal resistive indexPatients with sepsis who develop AKI |
| Group 2 | – | Diagnostic Test: neutrophil gelatinase-associated lipocalin, Diagnostic Test: renal resistive indexPatients with sepsis who do not develop AKI |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients with sepsis in ICU.
Key inclusion criteria (2 listed)
- sepsis
- septic shock
Key exclusion criteria (1 listed)
- Weak abdominal echogenicity age < 18, other conditions causing shock (hypovolemic, cardiogenic, neurogenic), having a life expectancy of less than 24 hours, pregnancy, vasospastic disease, intraperitoneal pressure > 15 mm Hg, obstructive renal failure or suspected, presence of arrhythmia, presence of renal artery stenosis, kidney transplant patients presence of kidney tumor patients receiving dialysis treatment, solitary kidney and other kidney abnormalities, presence of coronary artery disease, presence of acute mesenteric ischemia, Those who have been using drugs that inhibit angiotensin converting enzyme (ACE) and angiotensin receptor blockers for the last 48 hours, Patients with severe acute or chronic renal failure defined as glomerular filtration rate (GFR) < 30 ml/min/1.73 m2
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 lipocalinWhen the patient is diagnosed with sepsis and on the 3rd day of the follow-up, blood samples will be taken and NGAL levels will measured. | Diagnostic test | Group 1, Group 2 |
| renal resistive indexWhen the patient is diagnosed with sepsis and on the 3rd day of the follow-up, renal resistive index will measure and record. | Diagnostic test | Group 1, Group 2 |
Primary outcome
NGAL
Time frame: at diagnosis
Blood NGAL
NGAL
Time frame: at the third days
Blood NGAL
Renal resistive index
Time frame: at diagnosis
renal resistive index guided ultrasound
Renal resistive index
Time frame: at the third days
renal resistive index guided ultrasound
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 3 Nov 2023.
- Background: PubMed 24235286Faubel S, Patel NU, Lockhart ME, Cadnapaphornchai MA. Renal relevant radiology: use of ultrasonography in patients with AKI. Clin J Am Soc Nephrol. 2014 Feb;9(2):382-94. doi: 10.2215/CJN.04840513. Epub 2013 Nov 14.
- Background: PubMed 33544258Renberg M, Jonmarker O, Kilhamn N, Rimes-Stigare C, Bell M, Hertzberg D. Renal resistive index is associated with acute kidney injury in COVID-19 patients treated in the intensive care unit. Ultrasound J. 2021 Feb 5;13(1):3. doi: 10.1186/s13089-021-00203-z.
- Background: PubMed 29889830Haitsma Mulier JLG, Rozemeijer S, Rottgering JG, Spoelstra-de Man AME, Elbers PWG, Tuinman PR, de Waard MC, Oudemans-van Straaten HM. Renal resistive index as an early predictor and discriminator of acute kidney injury in critically ill patients; A prospective observational cohort study. PLoS One. 2018 Jun 11;13(6):e0197967. doi: 10.1371/journal.pone.0197967. eCollection 2018.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Sepsis and Acute Kidney Injury, run by Inonu 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 2 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 3 Nov 2023. 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?
NGAL (time frame: at diagnosis). The study lists 4 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 NCT05374759, which also lists 3 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 3 Nov 2023.