Renal Arterial Resistive Index Versus Novel Biomarkers for Early Prediction of Sepsis Associated-acute Kidney Injury (RRIBIOSAKI)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03799159 |
|
Recruitment Status :
Completed
First Posted : January 10, 2019
Last Update Posted : March 2, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease |
|---|
| Sepsis Septic Shock Acute Kidney Injury |
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 Type : | Observational |
| Actual Enrollment : | 75 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| 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 |
| Actual Study Start Date : | May 15, 2019 |
| Actual Primary Completion Date : | February 28, 2021 |
| Actual Study Completion Date : | February 28, 2021 |
- 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.
- Mortality [ Time Frame: 28 days from inclusion ]All cause 28-days mortality
Biospecimen Retention: Samples Without DNA
Serum samples for neutrophil gelatinase-associated lipocalin (NGAL) and Cystatin C (CysC).
Urine samples for neutrophil gelatinase-associated lipocalin (NGAL)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Sampling Method: | Probability Sample |
Inclusion Criteria:
- Adult patients (aged above 18 years) recently admitted with sepsis
Exclusion Criteria:
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03799159
| Egypt | |
| Alexandria Main University Hospital | |
| Alexandria, Egypt, 21563 | |
| Principal Investigator: | Ibrahim Ibrahim, MSc | Assistant Lecturer of Critical Care Medicine, Kafr Elsheikh University | |
| Study Director: | Taysser Zaitoun, MD | Professor of Critical Care Medicine, Alexandria University | |
| Study Director: | Mohamed Megahed, MD | Professor of Critical Care Medicine, Alexandria University | |
| Study Chair: | Hisham Elghonemy, MD | Lecturer of Nephrology, Alexandria University | |
| Study Chair: | Doaa Emara, MD | Lecturer of Radiodiagnosis, Alexandria University | |
| Study Chair: | Islam Ahmed, PharmD | Clinical Pharmacy Specialist, Alexandria University |
| Responsible Party: | Islam Elsayed Mohamed Ahmed, Critical Care Clinical Pharmacy Specialist, Alexandria University |
| ClinicalTrials.gov Identifier: | NCT03799159 |
| Other Study ID Numbers: |
RRIBIOSAKI |
| First Posted: | January 10, 2019 Key Record Dates |
| Last Update Posted: | March 2, 2021 |
| Last Verified: | February 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | The summary of all relevant data |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
|
Sepsis Acute Kidney Injury Ultrasound Resistive Index Biomarkers |
|
Sepsis Toxemia Acute Kidney Injury Wounds and Injuries Infections Systemic Inflammatory Response Syndrome |
Inflammation Pathologic Processes Renal Insufficiency Kidney Diseases Urologic Diseases |