CLINICAL TRIAL

Personalized hydration strategy for Acute Kidney Injury

Recruiting · 18+ · All Sexes · Montréal, Canada

This study is evaluating whether a new hydration strategy can prevent CI-AKI in patients undergoing coronary angiogram and/or PCI.

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About the trial for Acute Kidney Injury

Eligible Conditions
Acute Kidney Injury · Contrast Induced Acute Kidney Injury

Treatment Groups

This trial involves 2 different treatments. Personalized Hydration Strategy is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Personalized hydration strategy
PROCEDURE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Standard of care
PROCEDURE

Eligibility

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
smoking cessation; aspirin The patient is scheduled for an angiogram and/or PCI show original
The willingness of participants to attend study visits is very high. show original
The patient is expected to live for at least six months. show original
Age ≥18 years;
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 6 months
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 6 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Personalized hydration strategy will improve 1 primary outcome and 9 secondary outcomes in patients with Acute Kidney Injury. Measurement will happen over the course of 7 days.

Contrast-induced acute kidney injury
7 DAYS
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
Stroke
6 MONTHS
Ischemic, hemorrhagic, or undetermined stroke
6 MONTHS
Hospital length-of-stay
6 MONTHS
Hospital length-of-stay after the procedure
6 MONTHS
Chronic kidney disease
6 MONTHS
50% increase from baseline serum creatinine
6 MONTHS
Myocardial infarction
6 MONTHS
Myocardial infarction (types 1-5)
6 MONTHS
MARCE composite with the addition of persistent increase of at least 50% from baseline serum creatinine
6 MONTHS
MARCE composite with the addition of persistent increase of at least 50% from baseline serum creatinine
6 MONTHS
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Who is running the study

Principal Investigator
G. M.
Prof. Guillaume Marquis-Gravel, Assistant professor, Université de Montreal
Montreal Heart Institute

Patient Q & A Section

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

What are common treatments for acute kidney injury?

Results from a recent clinical trial reinforces the need for the early identification and treatment of AKI for improving patient outcomes. In patients with AKI, the administration of hydration alone does not improve outcomes but is useful for lowering body fluid and electrolytes. Antibiotics did not result in improvement in renal outcome or shorter LOS. There were significant correlations between lower admission serum sodium and positive clinical outcomes.

Anonymous Patient Answer

What is acute kidney injury?

AKI incidence is similar in critically injured patients and medical ICU patients. Risk factors include sepsis, age ≥ 60 years, high serum creatinine and BUN, and increased CCI. AKI is an independent predictor of mortality. Treatment of patients with AKI in the hospital and outside the hospital (e.g. in the emergency department - ED) is recommended, since there is a much worse prognosis.

Anonymous Patient Answer

How many people get acute kidney injury a year in the United States?

The incidence of AKI in hospitalized pediatric patients increases with increasing age. The majority of pediatric AKI is the result of underlying chronic disease and the number of hospitalizations associated with AKI increases.

Anonymous Patient Answer

Can acute kidney injury be cured?

AKI is a complex condition with a diverse range of treatments and prognoses. Early recognition and correction of electrolyte imbalances with effective and prompt use of renal replacement therapy are critical in achieving good outcomes.

Anonymous Patient Answer

What are the signs of acute kidney injury?

A serum creatinine of 1.5 mg/dL or greater is indicative of acute kidney injury, and a urinary output of less than 0.5 mL/h is predictive of its subsequent deterioration. A serum lactate of>2.0 mmol/L with no improvement after 24 hours of correction with intravenous infusion is an ominous sign because a decrease in renal perfusion occurs within a day in that setting. In a nondiabetic patient with acute kidney injury and a urinary out of 0.9 mL/h, a serum creatinine level of 0.7 mg/dL or greater is associated with a 30% risk of in-hospital death.

Anonymous Patient Answer

What causes acute kidney injury?

There are many triggers that can cause AKI in the critically ill patient. These causes vary by patient and often have little effect on survival or renal recovery. The most obvious cause of AKI is AKI caused by nephrotoxic effects of dialysis, although this is also likely the case in chronic AKI, in which a direct injury (such as from injury) causes injury to the proximal tubule. AKI may have multiple etiologies and multiple manifestations. Understanding of these etiologies is critical to identifying appropriate therapies.

Anonymous Patient Answer

How does personalized hydration strategy work?

In critically ill patients with renal dysfunction, hydration strategy based on baseline and serial hydration measurements enables prediction of fluid responsiveness with a high degree of accuracy. Monitoring BUN and creatinine levels and urine output are indispensable components of this algorithm.

Anonymous Patient Answer

Does personalized hydration strategy improve quality of life for those with acute kidney injury?

This exploratory analysis shows that patients with AKI have a decreased quality of life with no improvement after personalized hydration. The study suggests these patients should be better served with less intensive interventions.

Anonymous Patient Answer

Is personalized hydration strategy safe for people?

Data from a recent study showed the feasibility of this personalized hydration strategy and recommended a personalized hydration strategy as a safe strategy to reduce fluid overload for patients on CAPD.

Anonymous Patient Answer

What are the latest developments in personalized hydration strategy for therapeutic use?

Hydration interventions to reduce sodium and volume loading, as well as the timing for initiating intervention, were found to have little positive effect on fluid overload or mortality in patients with acute kidney injury.

Anonymous Patient Answer

Is personalized hydration strategy typically used in combination with any other treatments?

The use of an hydration strategy tailored to a given patient is an increasingly common adjunct to the use of other treatment modalities when the goal of therapeutic care is to optimize patient outcome.

Anonymous Patient Answer

Who should consider clinical trials for acute kidney injury?

The evidence supporting the use of RASI and corticosteroids in the management of acute kidney injury is weak. There has been interest in the use of RASI in an attempt to halt further kidney damage but studies have been too inconsistent to show any convincing evidence for the efficacy or safety of these agents. However, we can assume that, despite their inconclusive evidence, they are not completely useless but we cannot and cannot be confident of their benefit. Clinical trials will be crucial for determining the most appropriate management for patients with AKI.

Anonymous Patient Answer
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