Clinical trial NCT03922958: Immunoparalysis in Acute Kidney Injury After Cardiac Surgery
Official title: Immunoparalysis in Acute Kidney Injury After Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Acute Kidney Injury
Immune Deficiency
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2019-04-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults undergoing cardiac surggery with CPB at University of Colorado Hospital (UCH)

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.

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.

Eligibility 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

Primary outcomes:
measure: Determine if patients with AKI have a higher rate of immunoparalyisis after CPB
timeFrame: 2 years
measure: Determine if the severity of immunoparalysis is greater among patients with AKI after CPB compared to patients without AKI after CPB.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
affiliation: UC Denver Anschutz Medical Campus
name: Sarah Faubel, MD
role: PRINCIPAL_INVESTIGATOR
References: