Acute Kidney Injury After Cardiac Surgery

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03457987
• Other study ID #: AZ 216/17
• Status: Completed
• Start date: March 1, 2018
• Est. completion date: January 21, 2023

Study information

• Verified date: June 2022
• Source: University of Giessen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 21, 2023
• Est. primary completion date: June 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Wounds and Injuries

Locations

Country	Name	City	State
Germany	University Clinic Giessen and Marburg - Campus Giessen	Gießen	Hessen

Sponsors (7)

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

Country where clinical trial is conducted

Germany, 

References & Publications (4)

Husain-Syed F, Ferrari F, Sharma A, Danesi TH, Bezerra P, Lopez-Giacoman S, Samoni S, de Cal M, Corradi V, Virzi GM, De Rosa S, Mucino Bermejo MJ, Estremadoyro C, Villa G, Zaragoza JJ, Caprara C, Brocca A, Birk HW, Walmrath HD, Seeger W, Nalesso F, Zanell — View Citation

Husain-Syed F, Ferrari F, Sharma A, Hinna Danesi T, Bezerra P, Lopez-Giacoman S, Samoni S, de Cal M, Corradi V, Virzi GM, De Rosa S, Mucino Bermejo MJ, Estremadoyro C, Villa G, Zaragoza JJ, Caprara C, Brocca A, Birk HW, Walmrath HD, Seeger W, Nalesso F, Z — View Citation

Ronco C, Kellum JA, Haase M. Subclinical AKI is still AKI. Crit Care. 2012 Jun 21;16(3):313. doi: 10.1186/cc11240. — View Citation

Sharma A, Zaragoza JJ, Villa G, Ribeiro LC, Lu R, Sartori M, Faggiana E, de Cal M, Virzi GM, Corradi V, Brocca A, Husain-Syed F, Brendolan A, Ronco C. Optimizing a kidney stress test to evaluate renal functional reserve. Clin Nephrol. 2016 Jul;86(7):18-26 — View Citation

Outcome

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