RecruitingNAINTERVENTIONAL

LoW Dose-Intensity vs. Standard Dose-Intensity COntinuous Renal ReplaceMent Therapy in Critically Ill Patients (WISDOM)

The WISDOM trial is studying how much continuous kidney dialysis (CRRT) is best for very sick patients in intensive care with sudden kidney failure. About 10-15% of these patients receive this type of dialysis. Doctors currently use a certain amount based on previous research. This study wants to find out if using a slightly lower amount of CRRT is just as effective and safe as the usual amount. It will also check if a lower dose could help patients recover from kidney failure quicker, shorten their time on dialysis, and be more cost-effective for hospitals. This is an important question because CRRT is a complex treatment.

At a glance

Status

Recruiting

Phase

Sponsor

University of Alberta

Enrolment target

100

Start

14 Nov 2024

Estimated completion

01 Jun 2027

Acute Kidney Injury Dialysis; Complications

What is this study about?

When people are very sick in intensive care, their kidneys can sometimes suddenly stop working properly. This is called acute kidney injury. To help the body clean itself, doctors might use a treatment called Continuous Renal Replacement Therapy (CRRT), which is a type of ongoing dialysis. Around 10 to 15 out of every 100 very sick patients in intensive care need this treatment.

Previously, some doctors thought that a higher amount of CRRT might be better. However, newer, more thorough studies showed that a certain lower amount was actually just as good and became the standard recommendation. Now, the WISDOM trial wants to take this one step further. No one has thoroughly tested if an even lower amount of CRRT could be just as good, or even better. This study aims to compare the currently recommended amount of CRRT with a slightly lower amount.

The main idea is to see if a lower amount of CRRT can help patients recover their kidney function faster, get off dialysis sooner, and still lead to similar health outcomes, while also being safer and potentially more cost-effective. This is important because CRRT is a complex and expensive treatment, and finding the right amount that helps patients without being excessive is a key goal.

Key takeaways

Critically ill patients with sudden kidney failure are the focus.
Compares standard CRRT dose with a lower CRRT dose.
Aims to see if less dialysis is just as good, safer, and helps kidney recovery.
Could help reduce dialysis time and hospital costs.
Participation involves monitoring your usual care and medical records.
Withdrawal from the study will not affect your medical care.

Who may be eligible?

This study is looking for adults aged 18 or older who weigh at least 55 kilograms (about 8 stone 9 pounds) and are critically ill in intensive care. You would need to be starting CRRT for sudden kidney failure, or have started it within the last 24 hours. The doctors in charge of your care would also need to believe you are likely to survive and need CRRT for at least 48 hours.

Before you can join, you or a close family member (if you're too unwell) would need to understand the study and agree to take part. In some cases, if approved by an ethics committee, agreement might be sought a little later.

However, you cannot join the study if your doctors have decided you specifically need a higher amount of CRRT for a medical reason, or if you already have long-term kidney failure and are on regular dialysis. Also, if you’ve had any other kidney dialysis for sudden kidney failure during your current hospital stay, or if you cannot follow the study's requirements, you would not be able to participate.

Quick self-check

Are you 18 or older?
Do you weigh at least 55 kg (about 8 stone 9 pounds)?
Are you in intensive care and starting CRRT for sudden kidney failure?
Do your doctors expect you to need CRRT for at least 2 days?
Are you NOT already on regular dialysis for long-term kidney failure?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you are eligible and agree to take part in the WISDOM trial, your treatment will be randomly assigned to receive either the standard amount of CRRT or a slightly lower amount. This assignment is like flipping a coin, ensuring a fair comparison between the two groups. You will then receive your assigned CRRT treatment while you are in the intensive care unit.

The study team will closely monitor your kidney function, your general health, and how long you need CRRT. They will collect information about your time on dialysis and how your kidneys recover. This monitoring will happen as part of your usual care in the intensive care unit. There are no additional visits or medications beyond your normal hospital treatment. The study will mainly involve collecting information from your medical records. The total duration of your participation will depend on how long you need CRRT and your hospital stay.

Potential risks and benefits

Participating in this study might help us understand the best way to deliver dialysis for critically ill patients, potentially leading to improved kidney recovery and shorter time on dialysis for future patients. However, there are no direct personal benefits guaranteed from taking part. The risks are similar to those involved with standard CRRT, as both groups receive this treatment. There is a chance that the lower dose of CRRT might not be as effective in some individuals, or conversely, that the standard dose might be more than necessary. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (9)

Mayo Clinic
Rochester, United States· Recruiting
University of Alberta Hospital
Edmonton, Canada· Recruiting
Grey Nuns Hospital
Edmonton, Canada· Recruiting
Sturgeon Community Hospital
St. Albert, Canada· Recruiting
Hamilton General Hospital
Hamilton, Canada· Recruiting
Sunnybrook Health Sciences Centre
North York, Canada· Recruiting
St Michael's Hospital
Toronto, Canada· Recruiting
Regina General Hospital/Saskatchewan Health Authority
Regina, Canada· Recruiting
Guy's & St Thomas' Hospitals
London, United Kingdom· Recruiting

Common questions

What is acute kidney injury?

It's when your kidneys suddenly stop working well, often during a serious illness.

What is CRRT?

It's a continuous blood filtering treatment for people with serious kidney problems, often used in intensive care.

Will I know if I'm getting a lower dose?

No, your treatment will be randomly assigned, and you won't know which dose you're receiving to keep the study fair.

Will this research change my usual care?

Your overall care will remain the same, but the specific amount of CRRT might be different based on your study group.

Who is running this study?

This study is called WISDOM and is comparing different amounts of CRRT for very sick patients with kidney failure.

How to find out more

Sean M Bagshaw, MD

bagshaw@ualberta.ca 780-248-1256 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.