Acute Kidney Injury After Cardiac Surgery

Last updated: January 21, 2023
Sponsor: University of Giessen
Overall Status: Completed

Phase

N/A

Condition

Kidney Failure

Renal Failure

Kidney Disease

Treatment

N/A

Clinical Study ID

NCT03457987
AZ 216/17
  • Ages > 18
  • All Genders

Study Summary

The investigators seek to determine whether a reduced preoperative renal functional reserve predicts postoperative acute kidney injury in patients with normal estimated glomerular filtration rates undergoing elective cardiac surgery.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subjects older than 18 years
  2. Subjects undergoing elective cardiac surgery (with or without cardiopulmonary bypass)
  3. Subjects with an estimated GFR ≥60 ml/min/1.73 m2 (CKD-Epidemiology Collaborationequation)
  4. Subjects who signed informed consent forms

Exclusion

Exclusion Criteria:

  1. Preexisting acute kidney injury (as determined by all available serum creatininevalues from hospital and outpatient medical records within the previous 90 days)
  2. Chronic kidney disease ≥ stage III (KDIGO)
  3. Subjects undergoing transcatheter aortic valve implantation (TAVI)
  4. Pregnancy
  5. Solitary kidney
  6. Diabetes mellitus type 1
  7. Recent cardiac arrest (within last 3 months)
  8. Liver failure or cirrhosis
  9. Total parenteral nutrition
  10. Hemoglobin <11 g/dl
  11. Sepsis
  12. History of malabsorption, chronic inflammatory bowel disease, short bowel, orpancreatic insufficiency
  13. Transplant donor or recipient
  14. Active autoimmune disease with renal involvement
  15. Rhabdomyolysis
  16. Prostate hypertrophy with International Prostate Symptom Score ≥20
  17. Active neoplasm
  18. Decompensated heart failure / inability to pause angiotensin-converting enzymeinhibitors or angiotensin II receptor blockers minimum 2 days before protein load
  19. Known iodine allergy (exclusion criteria only for those centres who use iohexol plasmaclearance for determination of GFR)
  20. TSH <0.3 µU/l (exclusion criteria only for those centres who use iohexol)
  21. Subjects who received intravenous radiocontrast agents within the 72 hours before theprotein load
  22. Subjects who received NSAIDs within 48 hours before the protein load

Study Design

Total Participants: 30
Study Start date:
March 01, 2018
Estimated Completion Date:
January 21, 2023

Study Description

Although acute kidney injury (AKI) frequently complicates cardiac surgery, methods to determine AKI risk in patients without underlying kidney disease are lacking. Renal functional reserve (RFR) can be used to measure the capacity of the kidney to increase glomerular filtration rate under conditions of physiological stress and may serve as a functional marker that assesses susceptibility to injury.

The investigators seek to determine whether a reduced preoperative RFR predicts postoperative AKI in patients with normal estimated glomerular filtration rates undergoing elective cardiac surgery. All centres will measure RFR with creatinine clearance, except University Hospital Giessen where in addition iohexol plasma-clearance will be used.

Connect with a study center

  • University Clinic Giessen and Marburg - Campus Giessen

    Gießen, Hessen 35392
    Germany

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.