1158 Participants Needed

Personalized Hydration Strategy for Acute Kidney Injury

(NEPTUNE Trial)

GM
Overseen ByGuillaume Marquis-Gravel, MD, MSc
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Guillaume Marquis-Gravel
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Personalized Hydration Strategy for Acute Kidney Injury?

Research shows that personalized hydration strategies, such as those guided by urine flow rate and central venous pressure, are more effective in preventing acute kidney injury compared to fixed-rate hydration. These tailored approaches help reduce the risk of kidney damage after procedures like coronary interventions.12345

Is the personalized hydration strategy for acute kidney injury safe for humans?

Research shows that personalized hydration strategies, like those guided by urine flow rate or left ventricular end-diastolic pressure, are generally safe for preventing kidney injury in patients undergoing heart procedures. These strategies do not significantly increase the risk of pulmonary edema (fluid in the lungs), suggesting they are safe for use in humans.12678

How is the personalized hydration strategy treatment different from other treatments for acute kidney injury?

The personalized hydration strategy is unique because it tailors the hydration process based on individual patient factors like left ventricular end-diastolic pressure (a measure of heart function), contrast volume, and baseline kidney function, rather than using a fixed-rate approach. This method aims to optimize hydration to prevent kidney injury more effectively by considering each patient's specific needs.12349

What is the purpose of 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).

Research Team

GM

Guillaume Marquis-Gravel, MD

Principal Investigator

Montreal Heart Institute

Eligibility Criteria

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.

Inclusion Criteria

Willingness to participate and to attend study visits
I am scheduled for a heart artery examination and/or treatment.
You are expected to live for at least 6 more months.

Exclusion Criteria

You have an intra-aortic balloon pump (IABP) in place.
I do not have shock related to heart problems or other causes at the time of the procedure.
I have had an emergency procedure for a heart attack.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a personalized or standard hydration strategy during and after coronary angiogram and/or PCI

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with serum creatinine measured at 48 hours, 7 days, and 6 months

6 months
Multiple visits (in-person and virtual)

Treatment Details

Interventions

  • Personalized hydration strategy
  • Standard of care
Trial Overview 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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Guillaume Marquis-Gravel

Lead Sponsor

Trials
1
Recruited
1,200+

Montreal Heart Institute

Lead Sponsor

Trials
125
Recruited
85,400+

Université de Montréal

Collaborator

Trials
223
Recruited
104,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials
1,417
Recruited
26,550,000+

Findings from Research

A systematic review of 8 randomized controlled trials with 2312 patients found that tailored hydration strategies, particularly urine flow rate-guided hydration, significantly reduce the incidence of contrast-induced acute kidney injury (CI-AKI) compared to fixed-rate hydration.
No significant difference in the incidence of pulmonary edema was observed between tailored and fixed hydration strategies, indicating that tailored approaches are both effective in preventing CI-AKI and safe regarding pulmonary complications.
Tailored Versus Standard Hydration to Prevent Acute Kidney Injury After Percutaneous Coronary Intervention: Network Meta-Analysis.Moroni, F., Baldetti, L., Kabali, C., et al.[2021]
In a study of 114 patients with chronic kidney disease undergoing cardiac procedures, LVEDP-guided hydration did not significantly reduce the incidence of contrast-induced acute kidney injury (CI-AKI) compared to standard hydration methods.
Both hydration strategies were safe, with no major adverse cardiac events or deaths reported during hospitalization or the 30-day follow-up period.
Left ventricular end-diastolic pressure-guided hydration for the prevention of contrast-induced acute kidney injury in patients with stable ischemic heart disease: the LAKESIDE trial.Marashizadeh, A., Sanati, HR., Sadeghipour, P., et al.[2020]
In a study of 551 patients with advanced congestive heart failure undergoing coronary procedures, higher hydration volumes (over 15 mL/kg) were linked to increased risks of contrast-induced acute kidney injury (CI-AKI) and worsening heart failure (WHF).
The findings suggest that while hydration is important, excessive volumes can lead to serious complications, indicating a need for personalized hydration strategies in high-risk patients.
Optimal hydration volume among high-risk patients with advanced congestive heart failure undergoing coronary angiography.Chen, SQ., Liu, Y., Bei, WJ., et al.[2019]

References

Tailored Versus Standard Hydration to Prevent Acute Kidney Injury After Percutaneous Coronary Intervention: Network Meta-Analysis. [2021]
Left ventricular end-diastolic pressure-guided hydration for the prevention of contrast-induced acute kidney injury in patients with stable ischemic heart disease: the LAKESIDE trial. [2020]
Optimal hydration volume among high-risk patients with advanced congestive heart failure undergoing coronary angiography. [2019]
Hydration for prevention of kidney injury after primary coronary intervention for acute myocardial infarction: a randomised clinical trial. [2022]
Machine learning for the prediction of volume responsiveness in patients with oliguric acute kidney injury in critical care. [2020]
Renal insufficiency following contrast media administration trial III: Urine flow rate-guided versus left-ventricular end-diastolic pressure-guided hydration in high-risk patients for contrast-induced acute kidney injury. Rationale and design. [2020]
Safe Hydration to Prevent Contrast-Induced Acute Kidney Injury and Worsening Heart Failure in Patients with Renal Insufficiency and Heart Failure Undergoing Coronary Angiography or Percutaneous Coronary Intervention. [2019]
Does the method of administering fluids matter for contrast-induced nephropathy? REMEDIAL III compares LVEDP versus urine flow-guided hydration. [2020]
Use of Contrast Medium Volume to Guide Prophylactic Hydration to Prevent Acute Kidney Injury After Contrast Administration: A Meta-Analysis. [2020]
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