RecruitingNAINTERVENTIONAL

Improved Hemodynamic Tolerance of Intermittent Hemodialysis Sessions in Intensive Care Unite Using Citrate- vs Acetate-based Dialysate

This research looks into how to make kidney dialysis safer for very sick patients in intensive care. Kidney dialysis is a treatment used when kidneys stop working properly. Sometimes, during dialysis, patients can experience a sudden drop in blood pressure, which can be dangerous. This study compares two slightly different fluids used during dialysis: one that contains citrate and another that contains acetate. Researchers want to see if the citrate-based fluid is better at preventing these blood pressure drops, making the dialysis process easier on the body. Finding a way to reduce these problems could improve the care for critically ill patients needing kidney support.

At a glance

Status

Recruiting

Phase

Sponsor

Centre Hospitalier de Bethune

Enrolment target

Start

07 Dec 2023

Estimated completion

01 Jul 2027

Intradialytic Hypotension

What is this study about?

When people are very unwell, especially in an intensive care unit (ICU), their kidneys can sometimes stop working properly. If this happens, a treatment called intermittent hemodialysis (often called kidney dialysis) might be needed to clean their blood. During this dialysis, a machine filters waste products and extra fluid from the blood, similar to what healthy kidneys do. However, for some very sick patients, this treatment can sometimes cause their blood pressure to drop suddenly, which can be worrying and potentially harmful.

Currently, a common fluid used in dialysis contains something called acetate. While current dialysis fluids have improved over time, a small amount of acetate in them might still contribute to these drops in blood pressure. Lately, doctors have started using a different type of fluid that contains citrate instead of acetate. This new fluid has the necessary approvals for use in hospitals, and some early ideas suggest it might be gentler on the body.

This study aims to directly compare these two types of dialysis fluids – the traditional acetate-based type and the newer citrate-based type. Doctors want to see if using the citrate fluid can help prevent those sudden blood pressure drops during dialysis. By understanding which fluid is better, they hope to make dialysis safer and more comfortable for critically ill patients, ultimately leading to better health outcomes.

Key takeaways

This study compares two types of dialysis fluid for critically ill patients.
The goal is to find if citrate fluid causes fewer blood pressure drops than acetate fluid.
It aims to make kidney dialysis safer and gentler for patients in intensive care.
Both types of fluids are already approved for use in hospitals.
Participation will involve close monitoring during your regular dialysis treatments.

Who may be eligible?

To take part in this study, you need to be an adult, 18 years or older, and currently staying in an intensive care unit. You must have a new and sudden problem with your kidneys that isn't due to a blockage, and your doctors need to be considering you for kidney dialysis. Importantly, you should also be considered at risk of having low blood pressure during dialysis; this might be checked by how quickly blood returns to your fingers after pressing them, how your heart and circulation are doing, or if you have slightly high lactic acid levels.

There are also reasons why you wouldn't be able to join the study. For example, if you are pregnant or breastfeeding, or if you already have a long-term kidney problem. If you have serious heart or liver conditions that affect your kidneys, or if your blood pressure is extremely unstable despite treatments, you wouldn't be suitable. Also, if you're already in another study that might affect your blood pressure, or if you're unable to give consent (for example, if you're under legal guardianship or deprived of your liberty), you wouldn't be able to participate.

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 currently in an intensive care unit (ICU)?
Do your doctors think you need kidney dialysis for a new (acute) kidney problem?
Are your doctors worried you might have low blood pressure during dialysis?
Are you not pregnant or breastfeeding?
Do you not have a long-term kidney condition or very unstable blood pressure due to other serious conditions?

Answer every question to see your result.

What does participation involve?

This study focuses on using a different type of fluid during your regular kidney dialysis sessions. You would receive either the standard acetate-based fluid or the newer citrate-based fluid during some or all of your dialysis treatments. The study aims to compare how your body, especially your blood pressure, reacts to each fluid. There will be no extra visits specifically for the study beyond your usual intensive care check-ups. Doctors and nurses will carefully monitor your blood pressure and other vital signs during and after your dialysis sessions. They will also collect routine blood tests, which are usually done as part of your care in the intensive care unit, to see how your body is responding to the dialysis fluid. The total duration of your participation would depend on how long you need intermittent hemodialysis during your stay in the ICU.

Potential risks and benefits

Participating in this study might offer the potential benefit of receiving a dialysis fluid that could be kinder to your body and help prevent drops in blood pressure, though this is what the study aims to find out. As with any medical procedure in intensive care, there are general risks associated with kidney dialysis itself, but this study doesn't introduce completely new treatments; it compares two approved types of dialysis fluid. Risks specifically related to the study are mainly that one fluid might not be better than the other, or in rare cases, a patient could experience an unexpected reaction, though both fluids are routinely used. You have the right to withdraw from the study at any time, for any reason, without affecting your medical care.

Locations (5)

Centre Hospitalier Béthune
Verified postcode
Béthune, France· Recruiting
CHU
Verified postcode
Caen, France· Recruiting
Centre Hospitalier Universitaire de Dijon
Verified postcode
Dijon, France· Recruiting
CHRU Nancy
Verified postcode
Nancy, France· Recruiting
CHU de ROUEN
Verified postcode
Rouen, France· Not yet recruiting

Common questions

What is kidney dialysis?

Kidney dialysis is a treatment that helps clean your blood when your kidneys aren't working properly, removing waste products and extra fluids from your body.

Why is this study important for people in intensive care?

People in intensive care are often very sick, and dialysis can sometimes cause their blood pressure to drop. This study hopes to find a way to make dialysis safer by reducing these blood pressure problems.

What is the difference between acetate-based and citrate-based fluids?

These are two slightly different mixtures used in dialysis to help clean your blood. Doctors want to see if the citrate-based fluid helps prevent blood pressure drops better than the acetate-based one.

Will taking part in the study change my regular care?

You will still receive your necessary kidney dialysis, but the study will determine which of the two approved fluids is used. Your medical monitoring will continue as normal in the intensive care unit.

Can I stop participating in the study if I change my mind?

Yes, you can choose to stop participating at any point, and this will not affect the medical care you receive.

How to find out more

Martin GÉRARD

mgerard@ch-bethune.fr 03.21.64.44.44 Official trial record

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