An observational study in Sepsis, Septic Shock and Acute Kidney Injury, sponsored by Islam Elsayed Mohamed Ahmed. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-02.
Sponsored by Islam Elsayed Mohamed Ahmed · Observational
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.
All included patients in this study will be assessed for the following:
Data Collection
Renal Biomarkers
Ultrasound evaluation of kidneys and renal Doppler
1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.
This study's enrollment of 75 is below the median of 160 across 931 observational studies indexed under Sepsis.
Browse Sepsis studies →This is the only study on the registry with Islam Elsayed Mohamed Ahmed as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Acute Kidney Injury
AKI is defined according to KDIGO (Kidney Disease Improving Global Outcomes)
Time frame: 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.
Time frame: 7 days from inclusion
Persistent Acute Kidney Injury
Persistent AKI is defined as persistent serum creatinine rise or oliguria after 3 days.
Time frame: 7 days from inclusion
Mortality
All cause 28-days mortality
Time frame: 28 days from inclusion
Plan to share: No — The summary of all relevant data
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.