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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

Immunoparalysis in Acute Kidney Injury After Cardiac Surgery

Clinicaltrials.gov identifier NCT03922958

Recruitment Status Recruiting

First Posted April 22, 2019

Last update posted April 27, 2020

Study Description

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:Immune Deficiency
    Acute Kidney Injury
  • Intervention/Treatment:
  • Phase: N/A
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.

Study Design
  • 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 2019
  • Estimated Primary Completion Date: February 2021
  • Estimated Study Completion Date: February 2021
Outcome Measures
  • 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

Eligibility Criteria
  • 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

Contacts and Locations
Contacts

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

Locations

United States, Colorado
University of Colorado Hospital
Aurora

Sponsors and Collaborators

University of Colorado, Denver

Investigators

Principal Investigator: Sarah Faubel, MD UC Denver Anschutz Medical Campus

More Information
  • Responsible Party: University of Colorado, Denver
  • ClinicalTrials.gov Identifier: NCT03922958 History of Changes
  • Other Study ID Numbers: 18-0127
  • First Posted: April 22, 2019 Key Record Dates
  • Last Update Posted: April 27, 2020
  • Last Verified: April 2020
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Acute Kidney Injury
    Immunologic Deficiency Syndromes
    Wounds and Injuries