|- candidate number||25656|
|- NTR Number||NTR6236|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||13-dec-2016|
|- Secondary IDs||METC Z 16-T-201|
|- Public Title||Furosemide forced diuresis with Renalguard versus standard care of treatment in the prevention of contrast induced nephropathy in patient receiving a lower extremity angioplasty.|
|- Scientific Title||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’|
|- hypothesis||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.
|- Healt Condition(s) or Problem(s) studied||Peripheral Arterial Disease, Contrast Induced Nephropathy |
|- 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
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||2-jan-2017|
|- planned closingdate||1-jan-2019|
|- Target number of participants||180|
|- Interventions||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.|
|- Primary outcome||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).|
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||Complication secondary to CIN prophylactic therapy |
- Dialysis due to CIN
- Acute pulmonary oedema
Post-operative in-hospital adverse events
- Acute myocardial infarction
Hospitalisation duration in days
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.
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.
|- Timepoints||Urine biomarkers: 4h post intervention.|
Serum creatinine: within 10 days prior to
intervention, post procedure at day; 1,3,30.
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| L.J.J. Bolt|
|- CONTACT for SCIENTIFIC QUERIES|| L.J.J. Bolt|
|- Sponsor/Initiator ||Zuyderland Hospital|
(Source(s) of Monetary or Material Support)
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||13-dec-2016 - 12-apr-2017|