No registrations found.
ID
Source
Health condition
- Peripheral arterial disease (PAD)
- Contrast induced nephropathy (CIN)
- Percutaneous transluminal angioplasty (PTA)
Sponsors and support
Intervention
Outcome measures
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
- Death
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.
Study objective
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.
Study design
Urine biomarkers: 4h post intervention.
Serum creatinine: within 10 days prior to
intervention, post procedure at day; 1,3,30.
Intervention
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.
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6089 |
| NTR-old | NTR6236 |
| Other | 16-T-201 : METC Z |