RecruitingNAINTERVENTIONAL

Optimization of Fluid Balance Guided by Bioelectrical Impedance Analysis in Patients Undergoing Continuous Renal Replacement Therapy in Critical Care

This study aims to find the best way to remove excess body fluid from critically ill patients in intensive care. When people are very sick, they can get too much fluid, which can harm their organs. Doctors often use a treatment called continuous renal replacement therapy (CRRT) to help remove this fluid, especially when other medicines don't work. However, knowing exactly how much fluid to remove can be tricky. This study will compare two methods: the usual doctor's judgment versus using a measurement from a special body scan (Bioelectrical Impedance Analysis, or BIA) to guide how much fluid to remove. The goal is to see if using the BIA scan helps patients lose the right amount of fluid over 72 hours of treatment.

At a glance

Status

Recruiting

Phase

Sponsor

Centre Hospitalier Universitaire, Amiens

Enrolment target

Start

26 Sep 2024

Estimated completion

01 Jun 2026

Congestion RRT UF Bio-impendance Analysis Fluid Removal Diuretics Overload

What is this study about?

When people are very unwell, especially in intensive care, their bodies can sometimes build up too much fluid. This extra fluid can put a strain on their organs and make it harder for them to get better. Doctors often try to remove this fluid, for example, by giving water pills (diuretics), but sometimes these don't work well enough.

In such cases, a treatment called continuous renal replacement therapy (CRRT) might be used. This is a special machine that helps to filter the blood and remove extra fluid, much like how healthy kidneys do. However, deciding exactly how much fluid to remove can be difficult. If not enough fluid is removed, it can continue to cause problems. But if too much fluid is removed too quickly, it can make the patient's blood pressure drop, which is also dangerous.

This study is trying to find a better way to make this important decision. It will compare the current method, where doctors use their experience and observations to decide, with a new approach. The new approach uses a special body scan called Bioelectrical Impedance Analysis (BIA). This scan measures how much fluid is in the body's tissues. The idea is that using this scan might help doctors remove the right amount of fluid more effectively over a 72-hour period.

Key takeaways

New approach to managing fluid in very sick patients.
Compares standard doctor's judgment with a body scan (BIA) guided method.
Aims for more precise fluid removal over 72 hours.
Could help prevent organ problems from too much fluid.
Involves patients already receiving kidney support (CRRT).

Who may be eligible?

To be able to join this study, you would need to be over 18 years old and a patient in the intensive care unit at Amiens-Picardie University Hospital. You would also have too much fluid in your body and be starting continuous renal replacement therapy (CRRT) because of kidney problems, such as very high levels of potassium, urea, or creatinine in your blood, or very low blood pH. Importantly, your blood pressure would need to be stable, even if you are receiving medication to help keep it up. You or your legal representative would also need to provide signed consent to participate.

However, some people would not be able to take part. This includes if you have certain medical devices like a pacemaker, or if you have an irregular heartbeat (like atrial fibrillation or flutter). You also couldn't join if you receive regular kidney dialysis, are expected to die soon, are on a breathing machine that supports your heart and lungs, are experiencing severe bleeding, or are pregnant. People under guardianship would also not be eligible.

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 over 18 years old?
Are you currently in intensive care?
Do you have too much fluid in your body?
Are you stable enough to receive continuous kidney support (CRRT)?
Do you have a pacemaker or other implanted electrical device (this would exclude you)?
Are you pregnant (this would exclude you)?

Answer every question to see your result.

What does participation involve?

If you or your loved one takes part in this study, you will already be receiving continuous renal replacement therapy (CRRT) in the intensive care unit. The main difference will be how the doctors decide how much fluid to remove using the CRRT machine. If you are in the 'standard' group, the doctors will continue to make this decision based on their usual assessment of your condition. If you are in the 'experimental' group, the amount of fluid removed will be guided by measurements from a special body scan called Bioelectrical Impedance Analysis (BIA).

The BIA scan is a simple, quick, and painless test that involves placing electrodes on your skin. These measurements would be taken periodically to help guide adjustments to your fluid removal. The study will look at your fluid balance and body water levels over a 72-hour period while you are on CRRT. There are no extra medications given as part of this study.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is that guiding fluid removal with the BIA scan might lead to more effective fluid balance, which could potentially improve recovery. However, this is a pilot study, meaning it's an early step to see if the new method is better, so there's no guarantee of direct personal benefit. There are also potential risks related to balancing fluid removal; removing too much or too little fluid can both have negative effects, though the study aims to find a safer approach. We understand that being in intensive care is a very difficult time, and you or your legal representative have the right to withdraw from the study at any time without it affecting your medical care.

Locations (1)

CHRU Amiens
Verified postcode
Salouël, France· Recruiting

Common questions

What is 'continuous renal replacement therapy' (CRRT)?

It's a type of slow and continuous kidney support machine treatment used in intensive care to filter blood and remove extra fluid and waste products.

What is 'Bioelectrical Impedance Analysis' (BIA)?

BIA is a safe and harmless scan that uses a tiny electrical current to measure the amount of fluid and muscle in your body.

Why is removing extra fluid so important?

Too much fluid can put stress on your heart and lungs and make it harder for your organs to work properly, slowing your recovery.

Will I receive different medicine if I join the study?

No, this study only looks at how the amount of fluid removed via CRRT is decided, not at new medicines.

Who is funding this study?

The information provided only states it's taking place at Amiens-Picardie University Hospital; specific funding information isn't detailed in the brief.

How to find out more

Christophe Beyls, MD

beyls.christophe@chu-amiens.fr 33 + 03 22 08 78 66 Official trial record

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