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Immunoparalysis in Acute Kidney Injury After Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT03922958
Recruitment Status : Recruiting
First Posted : April 22, 2019
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
Sarah Faubel, University of Colorado, Aurora

Brief Summary:
Infection and sepsis are common after acute kidney injury (AKI) and increase mortality. In this study, the investigators will determine whether patients with acute kidney injury after cardiac surgery have immunosuppression as judged by blood markers of immunoparalysis.

Condition or disease
Acute Kidney Injury Immune Deficiency

Detailed Description:
Immunoparalysis is an immunosuppressed state that occurs after a wide variety of insults including sepsis and cardiopulmonary bypass surgery. Due to the impaired infection fighting ability, patients with immunoparalysis are at risk of subsequent infection which can increase mortality. Immunoparalysis can be measured by two methods: 1) ex vivo endotoxin stimulation and 2) blood monocyte HLA-DR levels. Since sepsis is also a known complication of Acute Kidney Injury(AKI), the investigators hypothesize that AKI is a risk factor for immunoparalysis. The investigators plan to look at these blood factors of immune function from patients before and 3 days following cardiac surgery. Urine will also be collected from the patients before their surgery as well as the 3 days following for AKI biomarker measurement. This prospective cohort will enroll 300 patients and determine the duration and severity of immunoparalysis among patients who develop AKI and those who do not develop AKI.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Immunoparalysis in Acute Kidney Injury After Cardiac Surgery
Actual Study Start Date : February 22, 2019
Estimated Primary Completion Date : February 22, 2021
Estimated Study Completion Date : February 22, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery




Primary Outcome Measures :
  1. Determine if patients with AKI have a higher rate of immunoparalyisis after CPB [ Time Frame: 2 years ]
    Patients with AKI will have a higher rate of immunoparalysis compared to those without AKI when immunoparalysis is identified by TNF levels after ex vivo endotoxin stimulation. As well as patients with AKI will have a higher rate of immunoparalysis compared to those without AKI when immunoparalysis is identified by monocyte HLA-DR (mHLA-DR) expression.

  2. Determine if the severity of immunoparalysis is greater among patients with AKI after CPB compared to patients without AKI after CPB. [ Time Frame: 2 years ]
    Patients with more severe AKI (based on KDIGO stage) will have a greater severity of immunoparalysis based on lower TNF levels after ex vivo endotoxin stimulation or lower mHLA-DR. As well as among the entire cohort, a greater increase in serum creatinine from baseline will be associated lower TNF levels after ex vivo endotoxin stimulation or lower mHLA-DR.


Biospecimen Retention:   Samples With DNA
Whole blood samples and urine samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adults undergoing cardiac surggery with CPB at University of Colorado Hospital (UCH)
Criteria

Inclusion Criteria:

  • All adults undergoing cardiac surgery with CPB will be considered for enrollment.

Exclusion Criteria:

  • Factors that affect immune function or AKI assessment are the basis for exclusion criteria:

    • Concurrent disease associated with immunosuppression including malignancy, chronic infection (e.g., HIV, Hepatitis C), organ transplant and immunosuppressant medications
    • Documented acute infection with the past 1 month (e.g., pneumonia, urinary tract infection)
    • Prednisone or other steroid use currently or within the past one month
    • AKI at the time of surgery
    • ESRD requiring renal replacement therapy
    • Estimated GFR <45 mL/min (as judged by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation

Information from the National Library of Medicine

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): NCT03922958


Contacts
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Contact: Sarah Faubel, MD 303-724-4813 sarah.faubel@ucdenver.edu

Locations
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United States, Colorado
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
Contact: Sarah Faubel, MD    303-724-4813    sarah.faubel@ucdenver.edu   
Principal Investigator: Sarah Faubel, MD         
Sub-Investigator: Muhammed Aftab, MD         
Sponsors and Collaborators
University of Colorado, Aurora
Investigators
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Principal Investigator: Sarah Faubel, MD UC Denver Anschutz Medical Campus

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Responsible Party: Sarah Faubel, Principal Investigator, University of Colorado, Aurora
ClinicalTrials.gov Identifier: NCT03922958     History of Changes
Other Study ID Numbers: 18-0127
First Posted: April 22, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Wounds and Injuries
Acute Kidney Injury
Immunologic Deficiency Syndromes
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Immune System Diseases