What side effects are associated with this type of intervention?

Common treatments for Acute Kidney Injury (AKI) include fluid resuscitation with crystalloids (e.g., normal saline, Ringer's lactate) and albumin, as well as the use of diuretics like furosemide. Side effects of crystalloids can include hyperchloremia and metabolic acidosis, while albumin use may lead to allergic reactions and is more costly without clear additional benefit. Diuretics can cause electrolyte imbalances such as hypokalemia and hypomagnesemia. Fluid overload and pulmonary edema are risks if fluid management is not carefully monitored.

What prior FDA approvals exist?

The FDA has not approved specific drugs solely for the treatment of Acute Kidney Injury (AKI). However, fluid management strategies, including the use of crystalloids (e.g., normal saline, Ringer's lactate) and diuretics (e.g., furosemide), are commonly employed in clinical practice to manage fluid balance in AKI patients. These approaches aim to prevent and treat fluid accumulation, which is critical in the management of AKI, especially in critically ill patients receiving kidney replacement therapy. The focus is on achieving a neutral or negative fluid balance to improve patient outcomes.

What other types of research exist?

Promising novel alternatives to traditional fluid management protocols for AKI patients include the use of bioelectrical impedance analysis (BIA) tools, such as the InBody S10, to guide fluid management, and proactive prescription-based fluid management strategies that aim to achieve neutral or negative daily fluid balance. These methods are being investigated in ongoing clinical trials and show potential for improving fluid regulation and patient outcomes in 2024.

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Fluid Management

Protocol-based Fluid Management for Critical Illness (Probe-Fluid Trial)

N/A

Recruiting

Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility Criteria Checklist

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

Must have

Admitted to the ICU

Age ≥ 18 years

Must not have

Important ongoing fluid losses are present and/or are expected to require continued maintenance IV fluids during the next 48 hours

Severe burn injury (>10% of body surface area)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization through day 90

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a method to manage fluid levels in critically ill patients with severe kidney issues. The goal is to prevent and treat fluid buildup by removing excess fluid, potentially improving patient outcomes.

Who is the study for?

This trial is for adults over 18 in the ICU with acute kidney injury (AKI) who meet specific criteria related to changes in serum creatinine or urine output. They must be starting kidney replacement therapy soon or have started it within the last 48 hours. People can't join if they're not expected to receive full support, might leave ICU soon, have severe burns, extreme sodium levels, ongoing fluid loss, or if their care team thinks the trial isn't right for them.

What is being tested?

The study tests a protocol-based fluid management strategy against usual care in critically ill patients on kidney replacement therapy. The goal is to manage fluids more actively to prevent and treat fluid buildup by aiming for neutral or negative daily fluid balance.

What are the potential side effects?

Potential side effects are not explicitly listed but may include complications from imbalanced fluid levels such as dehydration or overhydration which could affect blood pressure, heart function, and electrolyte balance.

Eligibility Criteria

Inclusion Criteria

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

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I am currently in the Intensive Care Unit.

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I am 18 years old or older.

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I am starting kidney replacement therapy soon or have started it within the last 2 days.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need ongoing IV fluids for the next 2 days due to fluid loss.

Select...

I have severe burns covering more than 10% of my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within +/- 7 days of the 90-day time point following randomization.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within +/- 7 days of the 90-day time point following randomization.

This trial's timeline: 3 weeks for screening, Varies for treatment, and within +/- 7 days of the 90-day time point following randomization. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cumulative fluid balance

Secondary study objectives

Clinical: Death

Clinical: Hospital-free days

Clinical: ICU-free days

+11 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Protocolized fluid removalExperimental Treatment1 Intervention

Group II: Usual careActive Control1 Intervention

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Acute Kidney Injury (AKI) include fluid resuscitation, diuretics, and renal replacement therapy (RRT). Fluid resuscitation aims to restore adequate blood flow to the kidneys by administering intravenous fluids, which helps to prevent further kidney damage. Diuretics are used to increase urine output and reduce fluid overload, which can alleviate pressure on the kidneys. Renal replacement therapy, such as dialysis, removes waste products and excess fluids from the blood when the kidneys are unable to do so. Regulation of fluid balance is crucial in AKI management because both fluid overload and dehydration can exacerbate kidney injury. Maintaining a neutral or negative fluid balance, as studied in fluid management protocols, helps to optimize kidney function and improve patient outcomes.