Acute Kidney Injury After Cardiac Surgery

Preoperative Renal Functional Reserve to Predict Risk of Acute Kidney Injury After Cardiac Surgery: The IRRIV Task Force and Collaborators for the Prevention of Acute Kidney Injury

Sponsors

Lead Sponsor: University of Giessen

Collaborator: Guy's and St Thomas' NHS Foundation Trust
Shanghai Jiao Tong University School of Medicine
Robert Bosch Medical Center
Ospedale San Bortolo di Vicenza
Azienda Ospedaliero Universitaria Maggiore della Carita
Charite University, Berlin, Germany

Source 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.

Overall Status Recruiting
Start Date March 1, 2018
Completion Date November 30, 2020
Primary Completion Date September 30, 2020
Study Type Observational
Primary Outcome
Measure Time Frame
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
Secondary Outcome
Measure Time Frame
determine preoperative RFR accuracy based on receiver operating characteristic curve curve to predict acute kidney injury. Preoperative
To analyze an acute kidney injury risk prediction model based on clinical covariates. Preoperative
Mortality at 30 and 90 days 30 and 90 days after surgery
Length of stay in intensive care unit and hospital. Postoperative
Use and duration of renal replacement therapy during hospital stay. Postoperative
Renal replacement therapy dependence at days 30 and 90. 30 and 90 days after surgery
To evaluate renal function at three months after surgery. 3 months after surgery
To evaluate whether preoperative RFR is correlated to renal function at three months after surgery. Preoperative
To evaluate whether chronic kidney disease is associated to preoperative RFR. Preoperative
Enrollment 206
Condition
Eligibility

Sampling Method: Probability Sample

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Claudio Ronco, MD Study Director San Bortolo Hospital, Vicenza, Italy
Overall Contact

Last Name: Faeq Husain-Syed, MD

Phone: +49 641 99 42378

Email: [email protected]-giessen.de

Location
Facility: Status: Contact: Contact Backup: University Clinic Giessen and Marburg - Campus Giessen Faeq Husain-Syed, MD +49 641 985 42378 [email protected]
Location Countries

Germany

Verification Date

November 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Giessen

Investigator Full Name: Faeq Husain

Investigator Title: Senior Physician

Keywords
Has Expanded Access No
Condition Browse
Patient Data Yes
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov