RecruitingNAINTERVENTIONAL

Restrictive Fluid Management In Liver Transplantation (REFIL)

This study, called REFIL, is for adult patients with advanced liver disease who are having a liver transplant. Doctors usually give lots of fluids during this complex surgery. This study compares two different approaches to managing these fluids. One approach plans to give less fluid by controlling blood flow in certain areas and temporarily storing some of the patient's blood. The other approach aims to keep the heart pumping at its best by giving more fluids. This is an initial 'pilot' study to see if these fluid management strategies can be tested safely and effectively in a larger group of patients across different hospitals. The main goal is to understand if people are willing to join, if doctors can follow the study rules, and if we can collect all the necessary information about what happens after the surgery.

At a glance

Status

Recruiting

Phase

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Enrolment target

138

Start

25 Apr 2023

Estimated completion

01 Mar 2026

Liver Transplantation

What is this study about?

When someone has a liver transplant, it's a major operation, and doctors need to carefully manage how much fluid is given to the patient during surgery. This study, called REFIL, is exploring two different ways to do this. One method, called 'restrictive fluid management,' aims to use less fluid. This involves temporarily taking some blood out before the surgery starts and putting it back in later, along with carefully controlling other fluids to keep certain blood vessels from becoming too full. The idea behind this is that too much fluid can sometimes cause problems after surgery, so less fluid might lead to a smoother recovery for some patients.

The other method is a more 'liberal fluid management' approach. With this strategy, doctors focus on making sure the heart pumps as well as possible throughout the surgery by giving more fluids as needed. Both methods use special equipment to guide the doctors. This study isn't looking to see which method is definitely better yet, but rather to see if it's practical to conduct a larger study comparing these two important approaches.

This early study is important because it will help researchers understand if a larger study, involving many hospitals, can be done successfully. They are checking things like how many patients agree to take part, whether the medical teams can follow the study instructions accurately, and if they can gather all the health information needed after the transplant. If this pilot study goes well, it could lead to a bigger study that helps doctors decide the best way to manage fluids during liver transplants to improve patient outcomes.

Key takeaways

This study compares two ways of managing fluids during liver transplants.
It's for adults with severe, long-term liver disease having a transplant.
This is a 'pilot' study to see if a larger trial can be done successfully.
You would be assigned to one fluid management group randomly, like drawing lots.
Participation lasts for up to six months after your transplant, checking your recovery.
Your involvement helps improve future care for liver transplant patients.

Who may be eligible?

This study is looking for adults aged 18 or older who are having a liver transplant because of severe, long-term liver disease. This type of liver disease is often called end-stage liver disease (ESLD).

There are several reasons why someone might not be able to join the study. For example, if your liver transplant is due to a sudden liver failure, or if you have certain types of liver cancer without severe liver disease, you wouldn't be able to participate. Similarly, if you are having another organ (like a lung or heart) transplanted at the same time as your liver, you wouldn't be eligible.

Also, certain other health conditions would prevent participation, such as very severe kidney problems, very low blood (anemia), or if your blood pressure is very unstable and needs strong medication to keep it normal during the surgery.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you having a liver transplant for severe, long-term liver disease?
Are you not having another organ transplant (like heart or lung) at the same time?
Do you have stable kidney function (not serious chronic kidney failure)?
Do you not have very severe low blood (anemia)?
Is your blood pressure generally stable (not needing very high doses of specific medications to keep it up)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, your fluid management during your liver transplant surgery will be guided by one of the two strategies being tested. This will be decided randomly, like flipping a coin. One strategy involves aiming for less fluid, possibly with some of your blood temporarily stored and returned later. The other involves giving more fluids to help your heart pump effectively. You won't know which group you are in until just before the surgery. After your surgery, the research team will keep track of your recovery while you are in the hospital and for six months after you are discharged, or six months after your transplant if you are still in hospital. This usually involves reviewing your medical records and possibly asking you some questions about your health and recovery. There are no additional visits or medications beyond your standard transplant care. The total duration of your active involvement will be up to six months after your transplant.

Potential risks and benefits

Taking part in this study means that your medical team will follow a specific plan for managing your fluids during your liver transplant. This plan is carefully designed, but as with any medical procedure, there are potential risks associated with both fluid management strategies. However, both approaches are based on recognised medical practices. The potential benefit is that by participating, you help doctors gain important information that could improve care for future liver transplant patients. You are free to withdraw from the study at any time without affecting the quality of your medical care.

Locations (4)

Vancouver General Hospital
Verified postcode
Vancouver, Canada· Recruiting
London Health Sciences Centre
Verified postcode
London, Canada· Recruiting
Centre Hospitalier de l'Université de Montréal (CHUM)
Verified postcode
Montreal, Canada· Recruiting
McGill University Health Centre
Verified postcode
Montreal, Canada· Recruiting

Common questions

What is a 'restrictive fluid management strategy'?

This is a way doctors manage fluids during surgery that aims to give less fluid overall, sometimes involving temporarily storing your own blood and putting it back later. The goal is to see if this leads to fewer problems after surgery.

What is the 'optimized cardiac output liberal fluid management strategy'?

This is another way doctors manage fluids, where they give more fluids to make sure your heart is pumping as well as possible throughout the surgery. Both strategies use special monitors to guide treatment.

Will I know which fluid strategy I'm getting?

No, you won't know which strategy you're assigned to beforehand. It's decided randomly, and the medical team will manage your fluids according to that plan during your operation.

What is a 'pilot study'?

A pilot study is like a small-scale trial done before a much larger one. It helps researchers check if the study plan works, if patients are willing to join, and if they can collect all the necessary information, before committing to a big research effort.

Will this study help me directly?

While this study might not directly improve your outcome more than standard care, your participation is vital. It helps doctors learn more about the best ways to manage fluids during liver transplants, which could benefit many patients in the future.

How to find out more

François Martin Carrier, MD

francois.martin.carrier.med@ssss.gouv.qc.ca 514-890-8000 Official trial record

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