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

ConditionContrast-Induced Acute Kidney Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMontreal Heart Institute

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years;

Planned coronary angiogram and/or PCI;

Willingness to participate and to attend study visits;

Expected life expectancy ≥6 months.

Disqualifiers

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);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Personalized hydration strategy

    Procedure/Surgery

    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

    Procedure/Surgery

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

Treatment groups

1,158 Participants
are divided into 2 treatment groups
Group A: Personnalized hydration strategyExperimental treatment 1 intervention
Group B: Standard of careActive comparator 1 intervention

Trial outcomes

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

Time frame
7 days

Secondary outcomes

1

Major adverse renal and cardiovascular events (MARCE)

Composite of death, myocardial infarction, stroke, or renal replacement therapy

Time frame
6 months
2

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

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

Time frame
6 months
3

All-cause death

All-cause death

Time frame
6 months
4

Myocardial infarction

Myocardial infarction (types 1-5)

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Montreal Heart Institute

Lead sponsor

Université de Montréal

Collaborator

Canadian Institutes of Health Research (CIHR)

Collaborator

Source ClinicalTrials.gov
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