Furosemide forced diuresis with Renalguard versus standard care of treatment in the prevention of contrast induced nephropathy in patient receiving a lower extremity angioplasty.
- Conditions
- - Peripheral arterial disease (PAD)- Contrast induced nephropathy (CIN)- Percutaneous transluminal angioplasty (PTA)
- Registration Number
- NL-OMON20313
- Lead Sponsor
- Zuyderland MC
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Incidence of CIN after successful endovascular procedure 1,3 and 30 days postoperative (defined as a rise of >25% or >0.5mg/dL serum creatinine when compared with the baseline values).<br /><br /><br><br>2. Rising level of urine biomarkers after successful endovascular procedure. Defined as an area under the curve ROC (AUC ROC) > 0.7, measured on the recovery after PTA to diagnose CIN. The rise of biomarkers is compared to the rise of serum creatinine to detect CIN (rise of serum creatinine >0.5mg/dL or more than 25% increase after 48-72h when compared to the baseline values).
- Secondary Outcome Measures
Name Time Method 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, which require additional care. Such as; seroma, wound infection, false aneurysm, and re-occlusion or re-stenosis within 4 weeks after the intervention. <br />The surgeon will actively ask the patients whether complications occurred after hospital discharge, when the patient will present themselves in the outpatient clinic after 4 weeks.