Furosemide forced diuresis with matched hydration vs Standard care of treatment in the prevention of contrast mediated nephropathy (CIN) due to percutaneous transluminal angioplasty (PTA): a randomized controled trial

Conditions: narrowing of the arteries
Peripheral artery disease
10003216

Registration Number: NL-OMON43281

Lead Sponsor: Zuyderland Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 180

Inclusion Criteria

Patients aged 18 years or older, regardless of gender, and who are legally capable to make informed decision. The patients are diagnose with an impaired renal function and require an endovascular revascularisation of the lower limbs. The patients are diagnosed with peripheral arterial disease Fontaine IIb, III, IV.

Exclusion Criteria

-hypersensitivity to furosemide
-intravenous contrast 10 days prior to intervention
-expected to receive intravenous contrast within 72h after intervention
- contra indication to receive a Foley catheter

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. Incidence of CIN after successful endovascular procedure 1,3 and 30 days<br /><br>postoperative (defined as a rise of >25% or >0.5mg/dL serum creatinine when<br /><br>compared with the baseline values).<br /><br><br /><br>2. Rising level of urine biomarkers after successful endovascular procedure.<br /><br>Defined as an area under the curve ROC (AUC ROC) > 0.7, measured on the<br /><br>recovery after PTA to diagnose CIN. The rise of biomarkers is compared to the<br /><br>rise of serum creatinine to detect CIN (rise of serum creatinine >0.5mg/dL or<br /><br>more than 25% increase after 48-72h when compared to the baseline values).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Complication secondary to CIN prophylactic therapy<br /><br>- Dialysis due to CIN<br /><br>- Acute pulmonary oedema<br /><br>Post-operative in-hospital adverse events<br /><br>- Acute myocardial infarction<br /><br>- Death<br /><br>Hospitalisation duration in days<br /><br>Postoperative complication that manifest themselves after hospital discharge,<br /><br>which require additional care. Such as; seroma, wound infection, false<br /><br>aneurysm, and re-occlusion or re-stenosis within 4 weeks after the<br /><br>intervention. The surgeon will actively ask the patients whether complications<br /><br>occurred after hospital discharge, when the patient will present themselves in<br /><br>the outpatient clinic after 4 weeks. </p><br>