Effects of Oral Protein Load on Kidney Function in Patients Undergoing Cardiac Surgery

Acute Kidney Injury Clinical Trial

Official title:

Effects of Preoperative High Oral Protein Load on Short- and Long-term Renal Outcomes Following Cardiac Surgery - a Matched Case-control Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03102541
• Other study ID #: 79/16 F
• Status: Completed
• Start date: November 1, 2014
• Est. completion date: November 24, 2016

Study information

• Verified date: November 2018
• Source: University of Giessen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Acute kidney injury (AKI) occurs in approximately one-third of patients undergoing cardiac surgery (CS), and represents one of the most significant negative predictors of patient outcome in this population. In the healthy adult, a high protein meal is known to enhance glomerular filtration rate and is mediated by an increase in renal blood flow. The investigators hypothesized that preoperative oral protein load may precondition the kidneys for upcoming insults and reduce the rate of postoperative AKI and long-term renal outcome.

Description:

Acute kidney injury (AKI) occurs in approximately one-third of patients undergoing cardiac surgery (CS), and represents one of the most significant negative predictors of patient outcome in this population. To date, there is no therapy to prevent AKI. In the healthy adult, a high protein meal is known to enhance glomerular filtration rate (GFR) and is mediated by an increase in renal blood flow. The investigators hypothesized that preoperative oral protein load may induce an adaptive response of the kidneys, and precondition the kidneys for upcoming insults. In the present study, the investigators aimed to compare the prevalence and severity of AKI in patients undergoing oral high protein load of the 'Preoperative Renal Functional Reserve Predict Risk of AKI after Cardiac Operation' study to age- and gender-matched "controls" who had a standard preoperative care the day prior to surgery within the same period (November 2014-October 2015) at San Bortolo Hospital, Vicenza, Italy. Both groups were followed 1 year post-discharge to evaluate long-term renal outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: November 24, 2016
• Est. primary completion date: October 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Subjects older than 18 years undergoing elective cardiac surgery

2. Subjects older than 18 years with an estimated eGFR >60 ml/min/1.73 m2 (CKD-EPI)

3. Subjects who signed informed consent forms

Exclusion Criteria:

1. Pregnancy

2. Chronic kidney disease = stage III (KDIGO criteria)

3. Preexisting acute kidney injury (as determined by all available serum creatinine values from hospital and outpatient medical records within the previous 90 days)

4. Solitary kidney

5. Diabetes mellitus type 1

6. Recent cardiac arrest or myocardial infarction up to 7 days before surgery

7. Liver failure or cirrhosis

8. Total parenteral nutrition

9. Haemoglobin <11 g/dl

10. Sepsis

11. History of malabsorption, chronic inflammatory bowel disease, short bowel, or pancreatic insufficiency

12. Transplant donor or recipient

13. Active autoimmune disease with renal involvement

14. Rhabdomyolysis

15. Prostate hypertrophy with International Prostate Symptom Score =20

16. Transcatheter aortic valve implantation

17. Active neoplasm

18. Patients who did not pause angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers or received non-steroidal anti-inflammatory drugs a minimum of 48 hours before hospital admission.

19. Patients who received intravenous radiocontrast agents within the 72 hours before hospital admission.

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

Other:
• None intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Giessen

References & Publications (2)

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. doi: 10.5414/CN108497. — View Citation

Zarbock A, Schmidt C, Van Aken H, Wempe C, Martens S, Zahn PK, Wolf B, Goebel U, Schwer CI, Rosenberger P, Haeberle H, Görlich D, Kellum JA, Meersch M; RenalRIPC Investigators. Effect of remote ischemic preconditioning on kidney injury among high-risk patients undergoing cardiac surgery: a randomized clinical trial. JAMA. 2015 Jun 2;313(21):2133-41. doi: 10.1001/jama.2015.4189. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of AKI after cardiac surgery	using full Kidney Disease: Improving Global Outcomes criteria	7 days
Primary	Long-term change in estimated GFR	using CKD-Epidemiology Collaboration creatinine formula	3 months and 1 year after cardiac surgery