We hypothesise the following; 1. Lowering the incidence of contrast induced nephropathy is possible when the diuresis is increased up to >300 ml/hour during the intervention (PTA) and is continued up to 4hours after the revascularizing…
ID
Bron
Aandoening
- Peripheral arterial disease (PAD)
- Contrast induced nephropathy (CIN)
- Percutaneous transluminal angioplasty (PTA)
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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>
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).
Doel van het onderzoek
We hypothesise the following;
1. Lowering the incidence of contrast induced nephropathy is possible when the diuresis is increased up to >300 ml/hour during the intervention (PTA) and is continued up to 4hours after the revascularizing procedure, using furosemide matched hydration aided by the the Renalguard.
2. The development of CIN can be detected in an early stage by detecting certain urine biomarkers postoperative on the recovery, whereas diagnosing CIN is nog possible after 72h postoperative in the detection of increased serum creatinine.
Onderzoeksopzet
Urine biomarkers: 4h post intervention.
Serum creatinine: within 10 days prior to
intervention, post procedure at day; 1,3,30.
Onderzoeksproduct en/of interventie
Percutaneous transluminal angioplasty of the lower limbs. One group will receive pre-hydration as is common regarding hospital protocol. The intervention group will be hydrated using furosemide forced diuresis in combination with the Renalguard.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
-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
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6089 |
| NTR-old | NTR6236 |
| Ander register | 16-T-201 : METC Z |