ImproviNg rEnal Outcomes Following Coronary angiograPhy and/or percuTaneoUs coroNary intErventions

NCT04936607 | Recruiting

• 1 other identifier: ICM 2022-2949
• Study Type: interventional
• Target: 1,158
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Contrast-induced acute kidney injury

  Increase in creatinine of 1.5 times baseline within 7 days or increase in creatinine by 26.5 umol/L (i.e. 0.3 mg/dL) within 48 hours

  7 days

Secondary Outcomes (9)

• Major adverse renal and cardiovascular events (MARCE)

  6 months

• MARCE composite with the addition of persistent increase of at least 50% from baseline serum creatinine

  6 months

• All-cause death

  6 months

• Myocardial infarction

  6 months

• Stroke

  6 months

Study Arms (2)

Personnalized hydration strategy

EXPERIMENTAL

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.

Procedure: Personalized hydration strategy

Standard of care

ACTIVE COMPARATOR

In the control group, infusion rate will be of 1.5 ml/kg/h during the procedure, and for the 4 following hours.

Procedure: Standard of care

Interventions

Personalized hydration strategy PROCEDURE

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.

Personnalized hydration strategy

Standard of care PROCEDURE

In the control group, infusion rate will be of 1.5 ml/kg/h during the procedure, and for the 4 following hours.

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years;
• Planned coronary angiogram and/or PCI;
• Willingness to participate and to attend study visits;
• Expected life expectancy ≥6 months.

You may not qualify if:

• 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%.

Sponsors & Collaborators

• Montreal Heart Institute: lead
• Université de Montréal: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Montreal Heart Institute

Montreal, Quebec, H1T1C8, Canada

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Guillaume Marquis-Gravel, MD, MSc

  Montreal Heart Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guillaume Marquis-Gravel, MD, MSc

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor, Université de Montreal

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: June 23, 2021
• Study Start: June 28, 2021
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)