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

NCT03102541 | Completed

• 1 other identifier: 79/16 F
• Study Type: observational
• Target: 214
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (2)

• Occurrence of AKI after cardiac surgery

  using full Kidney Disease: Improving Global Outcomes criteria

  7 days

• Long-term change in estimated GFR

  using CKD-Epidemiology Collaboration creatinine formula

  3 months and 1 year after cardiac surgery

Study Arms (1)

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

Interventions

None intervention OTHER

Cardiac Surgery

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Giessen: lead

Related Publications (3)

• Zarbock A, Schmidt C, Van Aken H, Wempe C, Martens S, Zahn PK, Wolf B, Goebel U, Schwer CI, Rosenberger P, Haeberle H, Gorlich 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.

  PMID: 26024502 BACKGROUND

• 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.

  PMID: 27285313 BACKGROUND

• Husain-Syed F, Emlet DR, Wilhelm J, Danesi TH, Ferrari F, Bezerra P, Lopez-Giacoman S, Villa G, Tello K, Birk HW, Seeger W, Giavarina D, Salvador L, Fuhrman DY, Kellum JA, Ronco C; IRRIV-AKI Study Group. Effects of preoperative high-oral protein loading on short- and long-term renal outcomes following cardiac surgery: a cohort study. J Transl Med. 2022 May 10;20(1):204. doi: 10.1186/s12967-022-03410-x.

  PMID: 35538495 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Claudio Ronco, MD

  International Renal Research Institute of Vicenza, Vicenza, Italy

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Physician

Study Record Dates

• First Submitted: March 30, 2017
• First Posted: April 5, 2017
• Study Start: November 1, 2014
• Primary Completion: October 31, 2015
• Study Completion: November 24, 2016
• Last Updated: November 20, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Starting immediately after results have been published
• Access Criteria: by email request to first author