Preoperative Prediction of Acute Kidney Injury After Cardiac Surgery

NCT03092947 | Completed

• 1 other identifier: n63/14
• Study Type: observational
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief Summary

Although acute kidney injury (AKI) frequently complicates cardiac surgery, methods to determine AKI risk are lacking. Renal functional reserve (RFR), the capacity of the intact nephron mass to increase glomerular filtration rate (GFR), represents maximal filtration capacity. We hypothesized that preoperative RFR would predict postoperative AKI.

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• The predictive value of RFR for AKI in patients undergoing elective cardiac surgery

  1 day before cardiac surgery

Secondary Outcomes (2)

• Whether the occurrence of AKI (as defined by Kidney Disease Improving Global Outcomes criteria) impacts RFR three months after surgery in patients without ongoing reduced function defined by resting GFR

  3 months after cardiac surgery

• Whether urinary [TIMP-2][IGFBP7] predicts loss of RFR

  3 months after cardiac surgery

Interventions

No intervention OTHER

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 undergoing elective cardiac surgery

You may qualify if:

• Subjects older than 18 years
• Subjects undergoing elective cardiac surgery
• Subjects who signed informed consent forms

You may not qualify if:

• Pregnancy
• Chronic kidney disease ≥ stage III
• Solitary kidney
• Diabetes mellitus type 1
• Recent cardiac arrest
• Liver failure or cirrhosis
• Total parenteral nutrition
• Hemoglobin \<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
• Neoplasm

Sponsors & Collaborators

• University of Giessen: lead

Related Publications (6)

• Haase M, Kellum JA, Ronco C. Subclinical AKI--an emerging syndrome with important consequences. Nat Rev Nephrol. 2012 Dec;8(12):735-9. doi: 10.1038/nrneph.2012.197. Epub 2012 Sep 25.

  PMID: 23007617 RESULT

• 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 RESULT

• Ronco C, Chawla LS. Glomerular and Tubular Kidney Stress Test: New Tools for a Deeper Evaluation of Kidney Function. Nephron. 2016;134(3):191-194. doi: 10.1159/000449235. Epub 2016 Aug 30.

  PMID: 27577054 RESULT

• 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

• Husain-Syed F, Ferrari F, Sharma A, Hinna Danesi T, Bezerra P, Lopez-Giacoman S, Samoni S, de Cal M, Corradi V, Virzi GM, De Rosa S, Mucino Bermejo MJ, Estremadoyro C, Villa G, Zaragoza JJ, Caprara C, Brocca A, Birk HW, Walmrath HD, Seeger W, Nalesso F, Zanella M, Brendolan A, Giavarina D, Salvador L, Bellomo R, Rosner MH, Kellum JA, Ronco C. Persistent decrease of renal functional reserve in patients after cardiac surgery-associated acute kidney injury despite clinical recovery. Nephrol Dial Transplant. 2019 Feb 1;34(2):308-317. doi: 10.1093/ndt/gfy227.

  PMID: 30053231 DERIVED

• Husain-Syed F, Ferrari F, Sharma A, Danesi TH, Bezerra P, Lopez-Giacoman S, Samoni S, de Cal M, Corradi V, Virzi GM, De Rosa S, Mucino Bermejo MJ, Estremadoyro C, Villa G, Zaragoza JJ, Caprara C, Brocca A, Birk HW, Walmrath HD, Seeger W, Nalesso F, Zanella M, Brendolan A, Giavarina D, Salvador L, Bellomo R, Rosner MH, Kellum JA, Ronco C. Preoperative Renal Functional Reserve Predicts Risk of Acute Kidney Injury After Cardiac Operation. Ann Thorac Surg. 2018 Apr;105(4):1094-1101. doi: 10.1016/j.athoracsur.2017.12.034. Epub 2018 Jan 31.

  PMID: 29382510 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Collection of only residual material (blood, urine) for International Renal Research Institute

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

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 21, 2017
• First Posted: March 28, 2017
• Study Start: November 1, 2014
• Primary Completion: October 31, 2015
• Study Completion: February 28, 2016
• Last Updated: March 29, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share