ImproviNg rEnal Outcomes Following Coronary angiograPhy and/or percuTaneoUs coroNary intErventions: a Pragmatic, Adaptive, Patient-oriented Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The NEPTUNE triple-blind, active-placebo, adaptive, pragmatic, randomized trial aims to evaluate the effectiveness of a new intra-venous hydration strategy guided by left ventricular end-diastolic pressure (LVEDP), amount of contrast used, and baseline renal function, to prevent contrast-induced acute kidney injury (CI-AKI) and patient-oriented clinical endpoints in all-comer patients undergoing coronary angiogram and/or percutaneous coronary intervention (PCI).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age ≥18 years;
• Planned coronary angiogram and/or PCI;
• Willingness to participate and to attend study visits;
• Expected life expectancy ≥6 months.
Locations
Other Locations
Canada
Montreal Heart Institute
RECRUITING
Montreal
Contact Information
Primary
Guillaume Marquis-Gravel, MD, MSc
guillaume.marquis.gravel@umontreal.ca
(514) 376-3330
Time Frame
Start Date: 2021-06-28
Estimated Completion Date: 2027-07-31
Participants
Target number of participants: 1158
Treatments
Experimental: Personnalized hydration strategy
In the experimental group, NS infusion rate will be adjusted based on LVEDP for the whole duration of the procedure (\<13 mmHg: 5 ml/kg/h; 13-18 mmHg: 3 ml/kg/h; \>18 mmHg: 1.5 ml/kg/h), or for one hour, whichever is the longest. After the procedure, and for a duration of 4 hours, the hydration rate will be adjusted based on the (contrast volume:estimated glomerular filtration rate (eGFR)) ratio, according to the following scheme: 1.5 ml/kg/h if contrast volume/eGFR ratio \<2.0; 3 ml/kg/h for contrast volume/eGFR ratio 2.0-2.9; 5 ml/kg/h for contrast volume/eGFR ratio ≥3.0.
Active_comparator: Standard of care
In the control group, infusion rate will be of 1.5 ml/kg/h during the procedure, and for the 4 following hours.
Related Therapeutic Areas
Sponsors
Collaborators: Canadian Institutes of Health Research (CIHR), Université de Montréal
Leads: Montreal Heart Institute