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Trial record 3 of 20 for:    Cystatin | Recruiting, Not yet recruiting, Available Studies | Acute kidney injury

Renal Arterial Resistive Index Versus Novel Biomarkers for Early Prediction of Sepsis Associated-acute Kidney Injury (RRIBIOSAKI)

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ClinicalTrials.gov Identifier: NCT03799159
Recruitment Status : Recruiting
First Posted : January 10, 2019
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
Islam Elsayed Mohamed Ahmed, Alexandria University

Tracking Information
First Submitted Date January 8, 2019
First Posted Date January 10, 2019
Last Update Posted Date May 29, 2019
Actual Study Start Date May 15, 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 8, 2019)
  • 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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03799159 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 8, 2019)
Mortality [ Time Frame: 28 days from inclusion ]
All cause 28-days mortality
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Renal Arterial Resistive Index Versus Novel Biomarkers for Early Prediction of Sepsis Associated-acute Kidney Injury
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
Brief 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. 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:

  1. 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.
  2. 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.

  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.
  4. 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.
  5. 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
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:

Serum samples for neutrophil gelatinase-associated lipocalin (NGAL) and Cystatin C (CysC).

Urine samples for neutrophil gelatinase-associated lipocalin (NGAL)

Sampling Method Probability Sample
Study Population - Critically ill patients recently admitted with sepsis.
Condition
  • Sepsis
  • Septic Shock
  • Acute Kidney Injury
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 8, 2019)
75
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Ibrahim Ibrahim +2-01227179834 dr.sabri55@gmail.com
Contact: Islam Ahmed +2-01289849292
Listed Location Countries Egypt
Removed Location Countries  
 
Administrative Information
NCT Number NCT03799159
Other Study ID Numbers RRIBIOSAKI
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: The summary of all relevant data
Responsible Party Islam Elsayed Mohamed Ahmed, Alexandria University
Study Sponsor Islam Elsayed Mohamed Ahmed
Collaborators Not Provided
Investigators
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
PRS Account Alexandria University
Verification Date May 2019