Immunoparalysis in Acute Kidney Injury After Cardiac Surgery

NCT03922958 | Terminated

• 1 other identifier: 18-0127
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury; Immune Deficiency

Outcome Measures

Primary Outcomes (2)

• Determine if patients with AKI have a higher rate of immunoparalyisis after CPB

  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 years

• Determine if the severity of immunoparalysis is greater among patients with AKI after CPB compared to patients without AKI after CPB.

  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.

  2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults undergoing cardiac surggery with CPB at University of Colorado Hospital (UCH)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood samples and urine samples

MeSH Terms

Conditions

Acute Kidney Injury; Immunologic Deficiency Syndromes

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Immune System Diseases

Study Officials

• Sarah Faubel, MD

  UC Denver Anschutz Medical Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: April 22, 2019
• Study Start: February 22, 2019
• Primary Completion: May 30, 2022
• Study Completion: May 30, 2022
• Last Updated: February 14, 2023

Record last verified: 2023-02

Locations

US (1)