A Maastricht Contrast-Induiced-Nehropathy Guideline study (AMACING): prevention guidelines - appropriate and cost effective?
Completed
- Conditions
- acute kidney injury (AKI)acute renal insufficiency10029149
- Registration Number
- NL-OMON44751
- Lead Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 660
Inclusion Criteria
patients *18 years of age, with moderate renal insufficiency (eGFR *30ml/min/1.73m2), referred for prophylactic intravenous hydration before and after an elective contrast procedure.
Exclusion Criteria
emergency or intensive care patients, patients receiving or having received renal replacement therapy, patients with severe renal insufficiency (eGFR <30ml/min/1.73m2), patients <18 years of age, patients unable or unwilling to personally give informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The aim of the guidelines is to prevent CIN. Therefore, even though clinically<br /><br>relevant outcomes would be a preferable outcome measure, an evaluation of the<br /><br>(cost) effectiveness of the prophylactic treatment prescribed by these<br /><br>guidelines must have CIN incidence as primary outcome measure.<br /><br>The costs per CIN case prevented will be calculated based on the absolute<br /><br>difference in CIN incidence between the randomized groups with and without<br /><br>prophylactic intravenous hydration (non-inferiority randomized trial).<br /><br><br /><br>In addition, we will evaluate the performance of prophylactic intravenous<br /><br>hydration in the prevention of the clinically relevant effects: decrease in<br /><br>renal function, renal damage and 30-day morbidity/mortality. In the evaluation,<br /><br>we shall take complications of prophylactic intravenous hydration into account.</p><br>
- Secondary Outcome Measures
Name Time Method