Immunoparalysis in Acute Kidney Injury After Cardiac Surgery

NCT ID: NCT03922958

Last Updated: 2023-02-14

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-02-22
• Study Completion Date: 2022-05-30

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.

Conditions

Acute Kidney Injury; Immune Deficiency

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarah Faubel, MD

Role: PRINCIPAL_INVESTIGATOR

UC Denver Anschutz Medical Campus

Locations

University of Colorado Hospital

Aurora, Colorado, United States

Countries

United States

Other Identifiers

18-0127

Identifier Type: -

Identifier Source: org_study_id