Phase 3
N=294
RenalGuard System and Contrast Media
Chronic Kidney Disease
Bottom Line
View on ClinicalTrials.gov: NCT01098032 ↗Enrolled (actual)
294
Serious AEs
8.2%
Results posted
Mar 2015
Primary outcome: Primary: Number of Participants With Contrast-induced Acute Kidney Injury — 146; 146 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- RenalGuard system (Device); Systemic alone therapy (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Clinica Mediterranea
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Contrast-induced Acute Kidney Injury |
146; 146 | — |
| SECONDARY Rate of Kidney Injury and Major Adverse Events |
— | — |
| SECONDARY Changes in the Serum Cystatin C Concentration at 24 and 48 Hours After Contrast Exposure |
— | — |
| SECONDARY Changes in the Urine and Serum NGAL Concentration After Contrast Exposure |
— | — |
| SECONDARY the Rate of Acute Renal Failure Requiring Dialysis |
— | — |
| SECONDARY The Rate of In-hospital Major Adverse Events (i.e. Acute Myocardial Infarction, c) Renal Failure Requiring Dialysis, and d) Acute Pulmonary Edema) |
— | — |
| SECONDARY The Cost-effectiveness Ratio. |
— | — |
Summary
The purpose of the present study is to assess the role of the RenalGuard System as compared to the optimal strategy (sodium bicarbonate infusion plus N-acetylcysteine (NAC)) in high and very-high risk patients to prevent contrast-induced acute kidney injury contrast induced acute kidney injury (CI-AKI).
Consecutive patients with chronic kidney disease, referred to our institutions for coronary and/or peripheral procedures, will be randomly assigned to 1) prophylactic administration of sodium bicarbonate plus NAC (Systemic alone therapy group; n > 133) and 2) RenalGuard System treatment (RenalGuard group; n > 133). All enrolled patients must have an estimated glomerular filtration rate =0.3 mg/dL in the creatinine concentration 48 hours after the procedure.
This study will give important answers on how to prevent CI-AKI in high and very-high risk patients undergoing contrast media exposure.
Eligibility Criteria
Inclusion Criteria
- Age >=18 years
- Chronic kidney disease (estimated glomerular filtration rate <=30 ml/min/1.72 m2) and/or
- Risk score for contrast nephropathy ≥11 (according to the Mehran score; J Am Coll Cardiol 2004; 44: 1393-1399)
Exclusion Criteria
- Pregnancy
- Heart failure (NYHA functional class III-IV)
- Acute pulmonary edema
- Acute myocardial infarction
- Recent (<=2 days) contrast media exposure
- Patients enrolled in concomitant studies
- Administration of theophylline, dopamine, mannitol and fenoldopam.
- End-stage CKD (patients on chronic dialysis)
- Systemic hypotension (systolic blood pressure < 100 mg/dl).
- Multiple myeloma
Data sourced from ClinicalTrials.gov (NCT01098032). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.