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.

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 4 hours after intervention can detect PC-AKI in an earlier stage compared with the golden standard, serum creatinine 48-72 hours 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 4 hours postintervention.

ETHICS AND DISSEMINATION:

Study protocol is approved by the research ethics committee and institutional review board (reference number 16 T-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.

• Authors: Lars J J Bolt, Tim Anton Sigterman, Atilla G Krasznai, Cees-Jan J M Sikkink, Geert-Willem H Schurink, Lee Hans Bouwman
• Journal: BMJ open (BMJ Open) Vol. 8 Issue 9 Pg. e021842 (10 04 2018) ISSN: 2044-6055 [Electronic] England
• PMID: 30287607 (Publication Type: Clinical Trial Protocol, Journal Article)
• Copyright: © Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Chemical References

• Biomarkers
• Contrast Media
• Diuretics
• HAVCR1 protein, human
• Hepatitis A Virus Cellular Receptor 1
• IL18 protein, human
• Interleukin-18
• LCN2 protein, human
• Lipocalin-2
• Saline Solution
• Furosemide
• Creatinine

Topics

• Acute Kidney Injury (chemically induced, diagnosis, physiopathology, prevention & control)
• Angioplasty, Balloon, Coronary (adverse effects)
• Biomarkers (urine)
• Combined Modality Therapy (methods)
• Contrast Media (adverse effects)
• Creatinine (blood)
• Diuresis
• Diuretics (therapeutic use)
• Fluid Therapy
• Furosemide (therapeutic use)
• Glomerular Filtration Rate
• Hepatitis A Virus Cellular Receptor 1 (metabolism)
• Humans
• Interleukin-18 (urine)
• Lipocalin-2 (urine)
• Randomized Controlled Trials as Topic
• Renal Insufficiency, Chronic (complications, physiopathology)
• Saline Solution (administration & dosage)