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Personalized Hydration Strategy for Acute Kidney Injury (NEPTUNE Trial)

Q: How many participants are being accepted into this medical research project?

<p>Affirmative. According to clinicaltrials.gov, this research is actively recruiting participants since June 28th 2021; the most recent update was on January 19th 2022. 1158 individuals are required across one medical facility for successful completion of the trial.</p>

Q: Are there any open enrollment opportunities for this clinical trial?

<p>Indeed, the clinicaltrials.gov website reveals that this medical research project is in active recruitment mode. This study was first posted on June 28th 2021 and has been recently updated on January 19th 2022 with a goal of enrolling 1158 patients from one site.</p>

N/A

Recruiting

Led By Guillaume Marquis-Gravel, MD, MSc

Research Sponsored by Guillaume Marquis-Gravel

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Planned coronary angiogram and/or PCI

Age ≥18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

NEPTUNE Trial Summary

This trial is testing whether a new way of giving fluids intravenously can prevent a kidney injury that can be caused by the contrast used in some medical procedures.

Who is the study for?

This trial is for adults over 18 who are about to have a heart procedure like coronary angiogram or PCI and can attend follow-up visits. They should expect to live at least 6 more months. It's not for those in shock, having emergency procedures, recent contrast media exposure, severe heart valve disease, very weak hearts (LVEF <30%), or current kidney issues.Check my eligibility

What is being tested?

NEPTUNE is testing a new IV hydration method against the usual care to prevent kidney damage after heart imaging tests or treatments. The new method considers heart pressure readings, contrast amount used, and initial kidney function. Patients are randomly assigned to either group without knowing which one they're in.See study design

What are the potential side effects?

Potential side effects may include discomfort from IV placement and possible fluid overload due to personalized hydration strategy leading to symptoms like swelling or shortness of breath.

NEPTUNE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am scheduled for a heart artery examination and/or treatment.

Select...

I am 18 years old or older.

NEPTUNE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Contrast-induced acute kidney injury

Secondary outcome measures

All-cause death

Chronic kidney disease

Hospital length-of-stay

+6 more

NEPTUNE Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Personnalized hydration strategyExperimental Treatment1 Intervention

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.

Group II: Standard of careActive Control1 Intervention

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

0 / 2Eligibility criteria met

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Who is running the clinical trial?

Guillaume Marquis-GravelLead Sponsor

Montreal Heart InstituteLead Sponsor

120 Previous Clinical Trials

67,661 Total Patients Enrolled

3 Trials studying Acute Kidney Injury

391 Patients Enrolled for Acute Kidney Injury

Université de MontréalOTHER

214 Previous Clinical Trials

101,613 Total Patients Enrolled

Media Library

Personalized hydration strategy Clinical Trial Eligibility Overview. Trial Name: NCT04936607 — N/A

Acute Kidney Injury Research Study Groups: Personnalized hydration strategy, Standard of care

Acute Kidney Injury Clinical Trial 2023: Personalized hydration strategy Highlights & Side Effects. Trial Name: NCT04936607 — N/A

Personalized hydration strategy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04936607 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being accepted into this medical research project?

"Affirmative. According to clinicaltrials.gov, this research is actively recruiting participants since June 28th 2021; the most recent update was on January 19th 2022. 1158 individuals are required across one medical facility for successful completion of the trial."

Answered by AI

Are there any open enrollment opportunities for this clinical trial?

"Indeed, the clinicaltrials.gov website reveals that this medical research project is in active recruitment mode. This study was first posted on June 28th 2021 and has been recently updated on January 19th 2022 with a goal of enrolling 1158 patients from one site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Guillaume Marquis-Gravel 2021. "ImproviNg rEnal Outcomes Following Coronary angiograPhy and/or percuTaneoUs coroNary intErventions". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04936607.