New hydration strategy to prevent kidney injury during heart procedures
ImproviNg rEnal Outcomes Following Coronary angiograPhy and/or percuTaneoUs coroNary intErventions: a Pragmatic, Adaptive, Patient-oriented Randomized Controlled Trial
This study is testing a new personalized hydration method to see if it can help prevent kidney injury in people having heart procedures like angiograms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1158 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Montreal Heart Institute Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT04936607 on ClinicalTrials.gov |
What this trial studies
The NEPTUNE trial evaluates a personalized intravenous hydration strategy aimed at preventing contrast-induced acute kidney injury (CI-AKI) in patients undergoing coronary angiograms and/or percutaneous coronary interventions. Participants will be randomized to receive either a tailored hydration approach based on their left ventricular end-diastolic pressure and renal function or standard hydration. The trial is triple-blind, ensuring that both participants and operators are unaware of treatment allocations. Key outcomes include the incidence of CI-AKI and major adverse renal and cardiovascular events, assessed by an independent committee.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older scheduled for a coronary angiogram or PCI with a life expectancy of at least six months.
Not a fit: Patients experiencing cardiogenic shock, requiring emergent procedures, or with severe pre-existing conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of kidney injury in patients undergoing heart procedures.
How similar studies have performed: Previous studies have explored hydration strategies for CI-AKI, but this specific adaptive approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years; * Planned coronary angiogram and/or PCI; * Willingness to participate and to attend study visits; * Expected life expectancy ≥6 months. Exclusion Criteria: * Cardiogenic or non-cardiogenic shock at the time of the procedure; * Emergent procedures (e.g. STEMI); * Iodine-based contrast media received within 2 days; * Presence of Intra-Aortic Balloon Pump (IABP); * Cardiac arrest within 24 hours; * Pre-procedural AKI defined using the modified KDIGO criteria within 7 days; * Renal replacement therapy; * Severe aortic or mitral disease; * LVEF \<30%.
Where this trial is running
Montreal, Quebec
- Montreal Heart Institute — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Guillaume Marquis-Gravel, MD, MSc — Montreal Heart Institute
- Study coordinator: Guillaume Marquis-Gravel, MD, MSc
- Email: guillaume.marquis.gravel@umontreal.ca
- Phone: (514) 376-3330
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.