Acute Kidney Injury After Cardiac Surgery

NCT03457987 | Completed DMC

• 1 other identifier: AZ 216/17
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators seek to determine whether a reduced preoperative renal functional reserve predicts postoperative acute kidney injury in patients with normal estimated glomerular filtration rates undergoing elective cardiac surgery.

Conditions

Acute Kidney Injury

Keywords

protein load; cardiac surgery

Outcome Measures

Primary Outcomes (1)

• Whether a reduced preoperative RFR ≤15 ml/min/1.73 m2 increased the odds ratio for postoperative acute kidney injury in patients undergoing elective cardiac surgery.

  Renal functional reserve

  Preoperative

Secondary Outcomes (9)

• determine preoperative RFR accuracy based on receiver operating characteristic curve curve to predict acute kidney injury.

  Preoperative

• To analyze an acute kidney injury risk prediction model based on clinical covariates.

  Preoperative

• Mortality at 30 and 90 days

  30 and 90 days after surgery

• Length of stay in intensive care unit and hospital.

  Postoperative

• Use and duration of renal replacement therapy during hospital stay.

  Postoperative

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults undergoing elective cardiac surgery (with or without cardiopulmonary bypass) with an estimated GFR ≥60 ml/min/1.73 m2 (CKD-Epidemiology Collaboration equation)

You may qualify if:

• Subjects older than 18 years
• Subjects undergoing elective cardiac surgery (with or without cardiopulmonary bypass)
• Subjects with an estimated GFR ≥60 ml/min/1.73 m2 (CKD-Epidemiology Collaboration equation)
• Subjects who signed informed consent forms

You may not qualify if:

• Preexisting acute kidney injury (as determined by all available serum creatinine values from hospital and outpatient medical records within the previous 90 days)
• Chronic kidney disease ≥ stage III (KDIGO)
• Subjects undergoing transcatheter aortic valve implantation (TAVI)
• Pregnancy
• Solitary kidney
• Diabetes mellitus type 1
• Recent cardiac arrest (within last 3 months)
• 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

Sponsors & Collaborators

• University of Giessen: lead
• Guy's and St Thomas' NHS Foundation Trust: collaborator
• Shanghai Jiao Tong University School of Medicine: collaborator
• Robert Bosch Medical Center: collaborator
• Ospedale San Bortolo di Vicenza: collaborator
• Azienda Ospedaliero Universitaria Maggiore della Carita: collaborator
• Charite University, Berlin, Germany: collaborator

Study Sites (1)

University Clinic Giessen and Marburg - Campus Giessen

Giessen, Hesse, 35392, Germany

Location

Related Publications (4)

• 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 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, Kellum JA, Haase M. Subclinical AKI is still AKI. Crit Care. 2012 Jun 21;16(3):313. doi: 10.1186/cc11240.

  PMID: 22721504 RESULT

• 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 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Serum and urine

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

  San Bortolo Hospital, Vicenza, Italy

  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 1, 2018
• First Posted: March 8, 2018
• Study Start: March 1, 2018
• Primary Completion: June 23, 2022
• Study Completion: January 21, 2023
• Last Updated: January 25, 2023

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Starting 6 months after publication.

Locations

DE (1)