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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03102541
Enrollment
214
Registered
2017-04-05
Start date
2014-11-01
Completion date
2016-11-24
Last updated
2018-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury

Brief 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.

Detailed 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.

Interventions

OTHERNone intervention

Sponsors

University of Giessen
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Occurrence of AKI after cardiac surgery7 daysusing full Kidney Disease: Improving Global Outcomes criteria
Long-term change in estimated GFR3 months and 1 year after cardiac surgeryusing CKD-Epidemiology Collaboration creatinine formula

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026