Prevention of postcontrast acute kidney injury after percutaneous transluminal angioplasty by inducing RenalGuard controlled furosemide forced diuresis with matched hydration: study protocol for a randomised controlled trial

Lars J. J. Bolt*, Tim Anton Sigterman, Atilla G. Krasznai, Cees-Jan J. M. Sikkink, Geert-Willem H. Schurink, Lee Hans Bouwman

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

4 Citations (Web of Science)

Abstract

Introduction Percutaneous transluminal angioplasty (PTA) is often complicated due to postcontrast acute kidney injury (PC-AKI) in patients diagnosed with chronic kidney disease (CKD). Hydration therapy is the cornerstone in the prevention of PC-AKI. Furosemide forced diuresis with matched hydration using the RenalGuard system enables a steady balance between diuresis and hydration. A randomised controlled trial will be performed in order to investigate whether furosemide forced diuresis with matched hydration in combination with the RenalGuard system decreases incidence of PC-AKI in patients with CKD receiving a PTA of the lower extremities. Furthermore, we will investigate whether sampling of urine biomarkers 4hours after intervention can detect PC-AKI in an earlier stage compared with the golden standard, serum creatinine 48-72hours postintervention. Methods and analysis A single-centre randomised controlled trial will be conducted. Patients >18 years in need of a PTA of the lower extremities and diagnosed with CKD will be randomly assigned to receive either standard of care prehydration and posthydration or furosemide forced diuresis with matched hydration periprocedural using the RenalGuard system. Four hours postintervention, a urine sample will be collected of all participating patients. Serum creatinine will be sampled within 10 days prior to intervention as well as 1, 3 and 30 days postintervention. The primary endpoint is incidence of PC-AKI post-PTA. Secondary endpoint is the rise of urine biomarkers 4hours postintervention. Ethics and dissemination Study protocol is approved by the research ethics committee and institutional review board (reference number 16T-201 and NL59809.096.16). Study results will be disseminated by oral presentation at conferences and will be submitted to a peer-reviewed journal. It is anticipated that study results will offer a solution to contrast-induced nephropathy in patients with CKD receiving a PTA of the lower extremities. Trial registration number NTR6236; Pre-results. EudraCT number 2016-005072-10
Original languageEnglish
Article number021842
Number of pages8
JournalBMJ Open
Volume8
Issue number9
DOIs
Publication statusPublished - 1 Sep 2018

Keywords

  • peripheral arterial disease
  • percutaneous transluminal angioplasty
  • chronic kidney disease
  • contrast induced nephropathy
  • furosemide forced diuresis
  • post contrast acute kidney injury
  • CONTRAST-INDUCED NEPHROPATHY
  • CORONARY INTERVENTION
  • RISK
  • FAILURE
  • SYSTEM
  • INSUFFICIENCY
  • SALINE
  • GUIDE

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