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

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ClinicalTrials.gov Identifier: NCT03102541
Recruitment Status : Completed
First Posted : April 5, 2017
Last Update Posted : November 20, 2018
Sponsor:
Information provided by (Responsible Party):
Faeq Husain, University of Giessen

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.

Condition or disease Intervention/treatment
Acute Kidney Injury Other: None intervention

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.

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Study Type : Observational
Actual Enrollment : 214 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Effects of Preoperative High Oral Protein Load on Short- and Long-term Renal Outcomes Following Cardiac Surgery - a Matched Case-control Study
Actual Study Start Date : November 1, 2014
Actual Primary Completion Date : October 31, 2015
Actual Study Completion Date : November 24, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Group/Cohort Intervention/treatment
Cardiac Surgery
214 adult patients with estimated GFR ≥60 ml/min/1.73 m2 (CKD-Epidemiology Collaboration equation) undergoing elective cardiac surgery (coronary artery bypass, valve replacements, combined or other surgery, with cardiopulmonary bypass) between November 2014 and October 2015 at the San Bortolo Hospital, Vicenza, Italy
Other: None intervention



Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients with estimated GFR ≥60 ml/min/1.73 m2 (CKD-Epidemiology Collaboration equation) undergoing elective cardiac surgery (coronary artery bypass, valve replacements, combined or other surgery, with cardiopulmonary bypass) between November 2014 and October 2015 at the San Bortolo Hospital, Vicenza, Italy
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03102541


Sponsors and Collaborators
University of Giessen
Investigators
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Study Director: Claudio Ronco, MD International Renal Research Institute of Vicenza, Vicenza, Italy
Publications:
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Responsible Party: Faeq Husain, Senior Physician, University of Giessen
ClinicalTrials.gov Identifier: NCT03102541    
Other Study ID Numbers: 79/16 F
First Posted: April 5, 2017    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All IPD that underlie results in a publication
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: Starting immediately after results have been published
Access Criteria: by email request to first author

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases