SepsisRRIBIOSAKINCT03799159
Renal Arterial Resistive Index Versus Novel Biomarkers for Early Prediction of Sepsis Associated-acute Kidney Injury
An observational study of Sepsis and Septic Shock, run by Islam Elsayed Mohamed Ahmed at 1 site in Egypt.
Trial summary
Populations at high risk of Sepsis-Associated Acute Kidney Injury (SA-AKI) have been identified. Sources of sepsis, in particular, bloodstream infection, abdominal and genitourinary sepsis, and infective endocarditis, are associated with a higher likelihood of developing AKI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Septic Shock, Acute Kidney Injury
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 15 May 2019to 28 Feb 2021
- 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
- Adult, Older adult
Study population: - Critically ill patients recently admitted with sepsis.
Who may be able to join
- Adult patients (aged above 18 years) recently admitted with sepsis
Who cannot join
- Pregnant Females
- Patients with renal transplant.
- Patients with End Stage Renal Disease (ESRD).
- Patients with Chronic Kidney Disease (CKD) known with history, laboratory or ultrasonographic evaluation with chronic nephropathic changes.
- Patients with renal artery stenosis.
- Patients with obstructive uropathy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Renal Arterial Resistive Index Versus Novel Serum and Urinary Biomarkers for Early Prediction of Sepsis Associated-acute Kidney Injury in Critically Ill Patients
Populations at high risk of Sepsis-Associated Acute Kidney Injury (SA-AKI) have been identified. Sources of sepsis, in particular, bloodstream infection, abdominal and genitourinary sepsis, and infective endocarditis, are associated with a higher likelihood of developing AKI. Similar to the poor outcome of patients with sepsis, delayed administration of appropriate antimicrobial therapy was shown to be an independent predictor of the development of AKI. Incremental delays in antimicrobial delivery after the onset of hypotension showed a direct relationship with the development of AKI. The need for sensitive, simple and time-applicable biomarker to predict AKI development after renal insult is urgent.
Serum creatinine (sCr) and urea are used routinely for the diagnosis of AKI. However, these parameters are not accurate for the diagnosis of AKI. Cystatin C. (CysC) is suggested to be a good biomarker because of its constant rate of production, almost filtered by glomeruli (99%), has no significant protein binding and not secreted by renal tubule. Neutrophil gelatinase-associated lipocalin (NGAL) is recently identified and extensively investigated as a most promising early marker of AKI. Urinary NGAL is not only effective in detection of AKI but also its degree of expression might distinguish among AKI, prerenal azotemia and chronic kidney disease, and it is detectable before the accumulation of serum creatinine.
Read more
Ultrasonography (US) is used routinely to assess renal morphology. Renal Resistive Index (RRI) is a non-invasive Doppler-measured parameter that is directly correlated with intra-renal arterial resistance. RRI is defined as [(peak systolic velocity - end diastolic velocity)/ peak systolic velocity]. It theoretically ranges from 0 to 1 and it is normally lower than 0.7 with age differences. RRI calculation was found to be useful as an early indicator of the vascular resistance changes and in the determination of the optimal systemic hemodynamics required for renal perfusion.
The aim of this study is to compare the ability of arterial renal resistive index (RRI), serum and urinary neutrophil gelatinase-associated lipocalin (NGAL), Cystatin C (CysC) in early diagnosis and predicting the persistence of acute kidney injury in septic patients.
Read the detailed description
All included patients in this study will be assessed for the following:
- Data Collection
- Complete history taking (age, sex, illness, medications, etc.).
- Complete physical examination (Glasgow coma scale (GCS), temperature, blood pressure, urine output, heart rate, respiratory rate and chest auscultation).
- SOFA score, APACHE II score, and Quick SOFA (qSOFA).
- Routine laboratory investigations and Coagulation profile.
- C-reactive protein (CRP), and Serum lactate.
- Complete sepsis workup (chest x-ray, urine analysis, abdomen and pelvis ultrasound, microbiological cultures) to identify the source of sepsis.
- Renal Biomarkers
- Serum and urinary samples will be collected directly at time of enrollment (within 2 hours from admission). It will be assayed for serum creatinine, serum neutrophil gelatinase-associated lipocalin (NGAL), urinary NGAL and serum Cystatin C (CysC). Then, it will be repeated at day 3.
- Ultrasound evaluation of kidneys and renal Doppler
- In each patient, both kidneys will be examined with real-time ultrasound (US) with a 3.75-MHz transducer (ACUSON X 300). Pulsed Doppler US evaluation of the intrarenal arteries will be obtained at the same respective scanning frequencies. The color Doppler functions are set for a study focused on interlobar arteries, that is, the highest gains possible, the use of the lowest filters and a low pulse repetition frequency (PRF) of 1-1.5 kHz that must be preferred while always limiting the aliasing phenomenon.
- The renal resistance index (RRI, [peak systolic frequency shift-minimum diastolic frequency shift]/ peak systolic frequency shift) will be calculated from calibrated software. (26) All measurements will be performed by the same examiner.
- The renal resistive index (RRI) will be measured at time of enrollment (within 2 hours from admission) and 24 hours after admission.
- Treatment All patients will receive the standard treatment for management of sepsis on the guidelines of SCC (sepsis-3). The protocol of treatment will not be changed during the study time.
- Follow up - All patients will be followed up using urine output (UOP), serum creatinine, KDIGO (Kidney Disease Improving Global Outcomes) classification, the use of vasopressors and need for renal replacement therapy (RRT).
- Conditions
- Sepsis, Septic Shock, Acute Kidney Injury
- Keywords
- Sepsis, Acute Kidney Injury, Ultrasound, Resistive Index, Biomarkers
- Medical subject headings
- Sepsis, Shock, Septic, Acute Kidney Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Kidney Injury
AKI is defined according to KDIGO (Kidney Disease Improving Global Outcomes)
Measured: 7 days from inclusion
Transient Acute Kidney Injury
Transient AKI is defined as AKI with a cause of renal hypoperfusion and recovery within 3 days after inclusion. Recovery from AKI is defined as urine output normalization and/or serum creatinine decrease by 50% and/or serum creatinine normalization to its measured or estimated baseline level.
Measured: 7 days from inclusion
Persistent Acute Kidney Injury
Persistent AKI is defined as persistent serum creatinine rise or oliguria after 3 days.
Measured: 7 days from inclusion
Secondary outcomes (1)
Mortality
All cause 28-days mortality
Measured: 28 days from inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start15 May 2019
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Islam Elsayed Mohamed Ahmed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Islam Elsayed Mohamed Ahmed, Alexandria University
- Investigators
- Ibrahim Ibrahim, MSc, Principal investigator, Assistant Lecturer of Critical Care Medicine, Kafr Elsheikh UniversityTaysser Zaitoun, MD, Study director, Professor of Critical Care Medicine, Alexandria UniversityMohamed Megahed, MD, Study director, Professor of Critical Care Medicine, Alexandria UniversityHisham Elghonemy, MD, Study chair, Lecturer of Nephrology, Alexandria UniversityDoaa Emara, MD, Study chair, Lecturer of Radiodiagnosis, Alexandria UniversityIslam Ahmed, PharmD, Study chair, Clinical Pharmacy Specialist, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03799159
- Sponsor's protocol ID
- RRIBIOSAKI
- Acronym
- RRIBIOSAKI
- Status last verified
- Feb 2021
- First submitted
- 8 Jan 2019
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The summary of all relevant data
Publications
Bagshaw SM, George C, Bellomo R; ANZICS Database Management Committee. Early acute kidney injury and sepsis: a multicentre evaluation. Crit Care. 2008;12(2):R47. doi: 10.1186/cc6863. Epub 2008 Apr 10.
PubMed 18402655Bagshaw SM, Uchino S, Bellomo R, Morimatsu H, Morgera S, Schetz M, Tan I, Bouman C, Macedo E, Gibney N, Tolwani A, Oudemans-van Straaten HM, Ronco C, Kellum JA; Beginning and Ending Supportive Therapy for the Kidney (BEST Kidney) Investigators. Septic acute kidney injury in critically ill patients: clinical characteristics and outcomes. Clin J Am Soc Nephrol. 2007 May;2(3):431-9. doi: 10.2215/CJN.03681106. Epub 2007 Mar 21.
PubMed 17699448Bagshaw SM, Lapinsky S, Dial S, Arabi Y, Dodek P, Wood G, Ellis P, Guzman J, Marshall J, Parrillo JE, Skrobik Y, Kumar A; Cooperative Antimicrobial Therapy of Septic Shock (CATSS) Database Research Group. Acute kidney injury in septic shock: clinical outcomes and impact of duration of hypotension prior to initiation of antimicrobial therapy. Intensive Care Med. 2009 May;35(5):871-81. doi: 10.1007/s00134-008-1367-2. Epub 2008 Dec 9.
PubMed 19066848Schnell D, Deruddre S, Harrois A, Pottecher J, Cosson C, Adoui N, Benhamou D, Vicaut E, Azoulay E, Duranteau J. Renal resistive index better predicts the occurrence of acute kidney injury than cystatin C. Shock. 2012 Dec;38(6):592-7. doi: 10.1097/SHK.0b013e318271a39c.
PubMed 23042202Merrikhi A, Gheissari A, Mousazadeh H. Urine and serum neutrophil gelatinase-associated lipocalin cut-off point for the prediction of acute kidney injury. Adv Biomed Res. 2014 Jan 27;3:66. doi: 10.4103/2277-9175.125847. eCollection 2014.
PubMed 24627874Zhang Z, Lu B, Sheng X, Jin N. Cystatin C in prediction of acute kidney injury: a systemic review and meta-analysis. Am J Kidney Dis. 2011 Sep;58(3):356-65. doi: 10.1053/j.ajkd.2011.02.389. Epub 2011 May 20.
PubMed 21601330Mori K, Lee HT, Rapoport D, Drexler IR, Foster K, Yang J, Schmidt-Ott KM, Chen X, Li JY, Weiss S, Mishra J, Cheema FH, Markowitz G, Suganami T, Sawai K, Mukoyama M, Kunis C, D'Agati V, Devarajan P, Barasch J. Endocytic delivery of lipocalin-siderophore-iron complex rescues the kidney from ischemia-reperfusion injury. J Clin Invest. 2005 Mar;115(3):610-21. doi: 10.1172/JCI23056.
PubMed 15711640Mishra J, Dent C, Tarabishi R, Mitsnefes MM, Ma Q, Kelly C, Ruff SM, Zahedi K, Shao M, Bean J, Mori K, Barasch J, Devarajan P. Neutrophil gelatinase-associated lipocalin (NGAL) as a biomarker for acute renal injury after cardiac surgery. Lancet. 2005 Apr 2-8;365(9466):1231-8. doi: 10.1016/S0140-6736(05)74811-X.
PubMed 15811456Nickolas TL, O'Rourke MJ, Yang J, Sise ME, Canetta PA, Barasch N, Buchen C, Khan F, Mori K, Giglio J, Devarajan P, Barasch J. Sensitivity and specificity of a single emergency department measurement of urinary neutrophil gelatinase-associated lipocalin for diagnosing acute kidney injury. Ann Intern Med. 2008 Jun 3;148(11):810-9. doi: 10.7326/0003-4819-148-11-200806030-00003.
PubMed 18519927Zwiers AJ, de Wildt SN, van Rosmalen J, de Rijke YB, Buijs EA, Tibboel D, Cransberg K. Urinary neutrophil gelatinase-associated lipocalin identifies critically ill young children with acute kidney injury following intensive care admission: a prospective cohort study. Crit Care. 2015 Apr 21;19(1):181. doi: 10.1186/s13054-015-0910-0.
PubMed 25895828Haase-Fielitz A, Bellomo R, Devarajan P, Bennett M, Story D, Matalanis G, Frei U, Dragun D, Haase M. The predictive performance of plasma neutrophil gelatinase-associated lipocalin (NGAL) increases with grade of acute kidney injury. Nephrol Dial Transplant. 2009 Nov;24(11):3349-54. doi: 10.1093/ndt/gfp234. Epub 2009 May 27.
PubMed 19474273Schnell D, Darmon M. Renal Doppler to assess renal perfusion in the critically ill: a reappraisal. Intensive Care Med. 2012 Nov;38(11):1751-60. doi: 10.1007/s00134-012-2692-z. Epub 2012 Sep 22.
PubMed 23001447Bougle A, Duranteau J. Pathophysiology of sepsis-induced acute kidney injury: the role of global renal blood flow and renal vascular resistance. Contrib Nephrol. 2011;174:89-97. doi: 10.1159/000329243. Epub 2011 Sep 9.
PubMed 21921613
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Arterial Resistive Index Versus Novel Serum and Urinary Biomarkers for Early Prediction of Sepsis Associated-acute Kidney Injury in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT03799159
- Acronym / sponsor ID
- RRIBIOSAKI / RRIBIOSAKI
- Conditions
- Sepsis, Septic Shock, Acute Kidney Injury
- Keywords
- Sepsis, Acute Kidney Injury, Ultrasound, Resistive Index, Biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Islam Elsayed Mohamed AhmedUniversity, hospital or other
- Study start
- 15 May 2019 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 10 Jan 2019 (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.
Populations at high risk of Sepsis-Associated Acute Kidney Injury (SA-AKI) have been identified. Sources of sepsis, in particular, bloodstream infection, abdominal and genitourinary sepsis, and infective endocarditis, are associated with a higher likelihood of developing AKI. Similar to the poor outcome of patients with sepsis, delayed administration of appropriate antimicrobial therapy was shown to be an independent predictor of the development of AKI. Incremental delays in antimicrobial delivery after the onset of hypotension showed a direct relationship with the development of AKI. The need for sensitive, simple and time-applicable biomarker to predict AKI development after renal insult is urgent.
Serum creatinine (sCr) and urea are used routinely for the diagnosis of AKI. However, these parameters are not accurate for the diagnosis of AKI. Cystatin C. (CysC) is suggested to be a good biomarker because of its constant rate of production, almost filtered by glomeruli (99%), has no significant protein binding and not secreted by renal tubule. Neutrophil gelatinase-associated lipocalin (NGAL) is recently identified and extensively investigated as a most promising early marker of AKI. Urinary NGAL is not only effective in detection of AKI but also its degree of expression might distinguish among AKI, prerenal azotemia and chronic kidney disease, and it is detectable before the accumulation of serum creatinine.
Ultrasonography (US) is used routinely to assess renal morphology. Renal Resistive Index (RRI) is a non-invasive Doppler-measured parameter that is directly correlated with intra-renal arterial resistance. RRI is defined as [(peak systolic velocity - end diastolic velocity)/ peak systolic velocity]. It theoretically ranges from 0 to 1 and it is normally lower than 0.7 with age differences. RRI calculation was found to be useful as an early indicator of the vascular resistance changes and in the determination of the optimal systemic hemodynamics required for renal perfusion.
The aim of this study is to compare the ability of arterial renal resistive index (RRI), serum and urinary neutrophil gelatinase-associated lipocalin (NGAL), Cystatin C (CysC) in early diagnosis and predicting the persistence of acute kidney injury in septic patients.
Detailed description
All included patients in this study will be assessed for the following:
- Data Collection
- Complete history taking (age, sex, illness, medications, etc.).
- Complete physical examination (Glasgow coma scale (GCS), temperature, blood pressure, urine output, heart rate, respiratory rate and chest auscultation).
- SOFA score, APACHE II score, and Quick SOFA (qSOFA).
- Routine laboratory investigations and Coagulation profile.
- C-reactive protein (CRP), and Serum lactate.
- Complete sepsis workup (chest x-ray, urine analysis, abdomen and pelvis ultrasound, microbiological cultures) to identify the source of sepsis.
- Renal Biomarkers
- Serum and urinary samples will be collected directly at time of enrollment (within 2 hours from admission). It will be assayed for serum creatinine, serum neutrophil gelatinase-associated lipocalin (NGAL), urinary NGAL and serum Cystatin C (CysC). Then, it will be repeated at day 3.
- Ultrasound evaluation of kidneys and renal Doppler
- In each patient, both kidneys will be examined with real-time ultrasound (US) with a 3.75-MHz transducer (ACUSON X 300). Pulsed Doppler US evaluation of the intrarenal arteries will be obtained at the same respective scanning frequencies. The color Doppler functions are set for a study focused on interlobar arteries, that is, the highest gains possible, the use of the lowest filters and a low pulse repetition frequency (PRF) of 1-1.5 kHz that must be preferred while always limiting the aliasing phenomenon.
- The renal resistance index (RRI, [peak systolic frequency shift-minimum diastolic frequency shift]/ peak systolic frequency shift) will be calculated from calibrated software. (26) All measurements will be performed by the same examiner.
- The renal resistive index (RRI) will be measured at time of enrollment (within 2 hours from admission) and 24 hours after admission.
- Treatment All patients will receive the standard treatment for management of sepsis on the guidelines of SCC (sepsis-3). The protocol of treatment will not be changed during the study time.
- Follow up - All patients will be followed up using urine output (UOP), serum creatinine, KDIGO (Kidney Disease Improving Global Outcomes) classification, the use of vasopressors and need for renal replacement therapy (RRT).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- - Critically ill patients recently admitted with sepsis.
Key inclusion criteria (1 listed)
- Adult patients (aged above 18 years) recently admitted with sepsis
Key exclusion criteria (6 listed)
- Pregnant Females
- Patients with renal transplant.
- Patients with End Stage Renal Disease (ESRD).
- Patients with Chronic Kidney Disease (CKD) known with history, laboratory or ultrasonographic evaluation with chronic nephropathic changes.
- Patients with renal artery stenosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Acute Kidney Injury
Time frame: 7 days from inclusion
AKI is defined according to KDIGO (Kidney Disease Improving Global Outcomes)
Transient Acute Kidney Injury
Time frame: 7 days from inclusion
Transient AKI is defined as AKI with a cause of renal hypoperfusion and recovery within 3 days after inclusion. Recovery from AKI is defined as urine output normalization and/or serum creatinine decrease by 50% and/or serum creatinine normalization to its measured or estimated baseline level.
Persistent Acute Kidney Injury
Time frame: 7 days from inclusion
Persistent AKI is defined as persistent serum creatinine rise or oliguria after 3 days.
1 secondary outcome
Mortality
Time frame: 28 days from inclusion
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 2 Mar 2021.
- Background: PubMed 18402655Bagshaw SM, George C, Bellomo R; ANZICS Database Management Committee. Early acute kidney injury and sepsis: a multicentre evaluation. Crit Care. 2008;12(2):R47. doi: 10.1186/cc6863. Epub 2008 Apr 10.
- Background: PubMed 17699448Bagshaw SM, Uchino S, Bellomo R, Morimatsu H, Morgera S, Schetz M, Tan I, Bouman C, Macedo E, Gibney N, Tolwani A, Oudemans-van Straaten HM, Ronco C, Kellum JA; Beginning and Ending Supportive Therapy for the Kidney (BEST Kidney) Investigators. Septic acute kidney injury in critically ill patients: clinical characteristics and outcomes. Clin J Am Soc Nephrol. 2007 May;2(3):431-9. doi: 10.2215/CJN.03681106. Epub 2007 Mar 21.
- Background: PubMed 19066848Bagshaw SM, Lapinsky S, Dial S, Arabi Y, Dodek P, Wood G, Ellis P, Guzman J, Marshall J, Parrillo JE, Skrobik Y, Kumar A; Cooperative Antimicrobial Therapy of Septic Shock (CATSS) Database Research Group. Acute kidney injury in septic shock: clinical outcomes and impact of duration of hypotension prior to initiation of antimicrobial therapy. Intensive Care Med. 2009 May;35(5):871-81. doi: 10.1007/s00134-008-1367-2. Epub 2008 Dec 9.
- Background: PubMed 23042202Schnell D, Deruddre S, Harrois A, Pottecher J, Cosson C, Adoui N, Benhamou D, Vicaut E, Azoulay E, Duranteau J. Renal resistive index better predicts the occurrence of acute kidney injury than cystatin C. Shock. 2012 Dec;38(6):592-7. doi: 10.1097/SHK.0b013e318271a39c.
- Background: PubMed 24627874Merrikhi A, Gheissari A, Mousazadeh H. Urine and serum neutrophil gelatinase-associated lipocalin cut-off point for the prediction of acute kidney injury. Adv Biomed Res. 2014 Jan 27;3:66. doi: 10.4103/2277-9175.125847. eCollection 2014.
- Background: PubMed 21601330Zhang Z, Lu B, Sheng X, Jin N. Cystatin C in prediction of acute kidney injury: a systemic review and meta-analysis. Am J Kidney Dis. 2011 Sep;58(3):356-65. doi: 10.1053/j.ajkd.2011.02.389. Epub 2011 May 20.
- Background: PubMed 15711640Mori K, Lee HT, Rapoport D, Drexler IR, Foster K, Yang J, Schmidt-Ott KM, Chen X, Li JY, Weiss S, Mishra J, Cheema FH, Markowitz G, Suganami T, Sawai K, Mukoyama M, Kunis C, D'Agati V, Devarajan P, Barasch J. Endocytic delivery of lipocalin-siderophore-iron complex rescues the kidney from ischemia-reperfusion injury. J Clin Invest. 2005 Mar;115(3):610-21. doi: 10.1172/JCI23056.
- Background: PubMed 15811456Mishra J, Dent C, Tarabishi R, Mitsnefes MM, Ma Q, Kelly C, Ruff SM, Zahedi K, Shao M, Bean J, Mori K, Barasch J, Devarajan P. Neutrophil gelatinase-associated lipocalin (NGAL) as a biomarker for acute renal injury after cardiac surgery. Lancet. 2005 Apr 2-8;365(9466):1231-8. doi: 10.1016/S0140-6736(05)74811-X.
- Background: PubMed 18519927Nickolas TL, O'Rourke MJ, Yang J, Sise ME, Canetta PA, Barasch N, Buchen C, Khan F, Mori K, Giglio J, Devarajan P, Barasch J. Sensitivity and specificity of a single emergency department measurement of urinary neutrophil gelatinase-associated lipocalin for diagnosing acute kidney injury. Ann Intern Med. 2008 Jun 3;148(11):810-9. doi: 10.7326/0003-4819-148-11-200806030-00003.
- Background: PubMed 25895828Zwiers AJ, de Wildt SN, van Rosmalen J, de Rijke YB, Buijs EA, Tibboel D, Cransberg K. Urinary neutrophil gelatinase-associated lipocalin identifies critically ill young children with acute kidney injury following intensive care admission: a prospective cohort study. Crit Care. 2015 Apr 21;19(1):181. doi: 10.1186/s13054-015-0910-0.
- Background: PubMed 19474273Haase-Fielitz A, Bellomo R, Devarajan P, Bennett M, Story D, Matalanis G, Frei U, Dragun D, Haase M. The predictive performance of plasma neutrophil gelatinase-associated lipocalin (NGAL) increases with grade of acute kidney injury. Nephrol Dial Transplant. 2009 Nov;24(11):3349-54. doi: 10.1093/ndt/gfp234. Epub 2009 May 27.
- Background: PubMed 23001447Schnell D, Darmon M. Renal Doppler to assess renal perfusion in the critically ill: a reappraisal. Intensive Care Med. 2012 Nov;38(11):1751-60. doi: 10.1007/s00134-012-2692-z. Epub 2012 Sep 22.
- Individual participant dataSharing planned: No. The summary of all relevant data
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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.
Ibrahim Ibrahim, MSc principal investigator
Assistant Lecturer of Critical Care Medicine, Kafr Elsheikh University
Taysser Zaitoun, MD study director
Professor of Critical Care Medicine, Alexandria University
Mohamed Megahed, MD study director
Professor of Critical Care Medicine, Alexandria University
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 Septic Shock, run by Islam Elsayed Mohamed Ahmed at 1 site in Egypt.
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 6 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 2 Mar 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 Egypt. 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?
Acute Kidney Injury (time frame: 7 days from inclusion). The study lists 3 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 NCT03799159, which also lists 13 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 2 Mar 2021.