Acute Kidney Injury After Cardiac Surgery

Completed

• Conditions: Acute Kidney Injury

• Registration Number: NCT03457987
• Lead Sponsor: University of Giessen

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2018-03-01
• Study First Submitted: 2018-03-01
• Study First Submitted QC: 2018-03-06
• Study First Posted: 2018-03-08
• Status Verified: 2022-06
• Primary Completion: 2022-06-23
• Study Completion: 2023-01-21
• Last Update Submitted: 2023-01-21
• Last Update Posted: 2023-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 Collaboration equation)
4. Subjects who signed informed consent forms

Exclusion Criteria

1. Preexisting acute kidney injury (as determined by all available serum creatinine values 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, or pancreatic 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 enzyme inhibitors or angiotensin II receptor blockers minimum 2 days before protein load
19. Known iodine allergy (exclusion criteria only for those centres who use iohexol plasma clearance 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 the protein load
22. Subjects who received NSAIDs within 48 hours before the protein load

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Whether a reduced preoperative RFR ≤15 ml/min/1.73 m2 increased the odds ratio for postoperative acute kidney injury in patients undergoing elective cardiac surgery.	Preoperative	Renal functional reserve

Secondary Outcome Measures

Name	Time	Method
To evaluate whether chronic kidney disease is associated to preoperative RFR.	Preoperative	Renal functional reserve
determine preoperative RFR accuracy based on receiver operating characteristic curve curve to predict acute kidney injury.	Preoperative	Renal functional reserve
Mortality at 30 and 90 days	30 and 90 days after surgery	Mortality
To evaluate renal function at three months after surgery.	3 months after surgery	Estimated glomerular filtration rate
To analyze an acute kidney injury risk prediction model based on clinical covariates.	Preoperative	Renal functional reserve
Length of stay in intensive care unit and hospital.	Postoperative	Hospital stay
Use and duration of renal replacement therapy during hospital stay.	Postoperative	Renal replacement therapy
Renal replacement therapy dependence at days 30 and 90.	30 and 90 days after surgery	Renal replacement therapy
To evaluate whether preoperative RFR is correlated to renal function at three months after surgery.	Preoperative	Renal functional reserve

Trial Locations

Locations (1)

University Clinic Giessen and Marburg - Campus Giessen; 🇩🇪 Gießen, Hessen, Germany