Furosemide forced diuresis with Renalguard versus standard care of treatment in the prevention of contrast induced nephropathy in patient receiving a lower extremity angioplasty.

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’

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20313

Enrollment

180

Registered

2016-12-13

Start date

2017-01-02

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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

Eligibility

Inclusion criteria

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

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 outcomes

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Primary

Measure	Time frame
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).	—

Measure

Time frame

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).

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Contacts

Public ContactL.J.J. Bolt

l.bolt@atriummc.nl

Outcome results