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NCT Number: NCT03102541

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects older than 18 years undergoing elective cardiac surgery
  • Subjects older than 18 years with an estimated eGFR >60 ml/min/1.73 m2 (CKD-EPI)
  • Subjects who signed informed consent forms

Exclusion criteria

  • Pregnancy
  • Chronic kidney disease ≥ stage III (KDIGO criteria)
  • Preexisting acute kidney injury (as determined by all available serum creatinine values from hospital and outpatient medical records within the previous 90 days)
  • Solitary kidney
  • Diabetes mellitus type 1
  • Recent cardiac arrest or myocardial infarction up to 7 days before surgery
  • Liver failure or cirrhosis
  • Total parenteral nutrition
  • Haemoglobin <11 g/dl
  • Sepsis
  • History of malabsorption, chronic inflammatory bowel disease, short bowel, or pancreatic insufficiency
  • Transplant donor or recipient
  • Active autoimmune disease with renal involvement
  • Rhabdomyolysis
  • Prostate hypertrophy with International Prostate Symptom Score ≥20
  • Transcatheter aortic valve implantation
  • Active neoplasm
  • 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.
  • Patients who received intravenous radiocontrast agents within the 72 hours before hospital admission.

Treatment and study plan

None intervention

Other

Primary outcomes

  1. Occurrence of AKI after cardiac surgery

    Time frame: 7 days

    using full Kidney Disease: Improving Global Outcomes criteria

  2. Long-term change in estimated GFR

    Time frame: 3 months and 1 year after cardiac surgery

    using CKD-Epidemiology Collaboration creatinine formula

Sponsors and collaborators

Lead sponsor

University of Giessen

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Apr 5, 2017
Registry last updated
Nov 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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