Recruiting

Intra-Venous Hydration

Sponsor:

Montreal Heart Institute

Code:

NCT04936607

Conditions

Contrast-Induced Acute Kidney Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Personalized hydration strategy

Standard of care

Study Details

Brief 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).

Conditions

Contrast-Induced Acute Kidney Injury

Study ID

NCT04936607

Start date

Jun 28, 2021

Status verified date

Dec, 2025

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jan 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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%.

Study Design

Enrollment

1158 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

Interventions

Personalized 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.

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.

Primary outcome measure

  • Contrast-induced acute kidney injury [ Time Frame: 7 days ]

Central Contacts and Locations

Central contacts

Guillaume Marquis-Gravel, MD, MSc

(514) 376-3330guillaume.marquis.gravel@umontreal.ca

Locations

Montreal Heart Institute

Recruiting

Montreal, Quebec, Canada, H1T1C8

Contacts

Guillaume Marquis-Gravel, MD, MSc

9195193271guillaume.marquis.gravel@umontreal.ca

More Information

Sponsor

Montreal Heart Institute

Last update posted

Dec 8, 2025

Last verified

Dec, 2025

Keywords

  • Randomized controlled trial
  • Pragmatic trial
  • Adaptive trial
  • Patient-oriented trial
  • Contrast-induced Nephropathy
  • Acute Kidney Injury
  • Coronary angiography
  • Percutaneous coronary intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Montreal Heart Institute on 2025-12-08.