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Ongoing, recruitingPhase III and phase IV (Integrated)Interventional

CA-CIBLE : Impact of increasing the ionized serum calcium target post-filter on the effectiveness of regional citrate anticoagulation during continuous extra-renal purification in intensive care: multicenter randomized controlled non-inferiority study.

This study, called CA-CIBLE, focuses on adult patients in intensive care who need a type of kidney support treatment called Continuous Renal Replacement Therapy (CRRT). For this treatment, a special fluid containing citrate is used to stop blood from clotting in the filter, but this can sometimes affect calcium levels. This study is testing if aiming for a slightly higher calcium level in the blood after the filter, using a specific fluid called Regiocit, can help prevent the filters from getting blocked. The main goal is to see if this change makes the treatment just as good, or even better, at keeping the filters working for longer. Researchers will also be looking at how long the filters last, why they stop working, and if there are any other side effects like changes in other body salts.

At a glance

Status
Ongoing, recruiting
Phase
Phase III and phase IV (Integrated)
Sponsor
Assistance Publique Hopitaux De Paris
Enrolment target
412
Start
25 Oct 2024

What is this study about?

When people are very unwell and in intensive care, their kidneys might struggle to work properly. In these situations, a treatment called Continuous Renal Replacement Therapy (CRRT) can be used to help clean their blood, much like kidneys do. During CRRT, blood is taken out of the body, passed through a special filter that removes waste products, and then returned to the body. To stop the blood from clotting in the filter, a special medicine called citrate is often added. While citrate is very effective at preventing clots, it can sometimes affect the calcium levels in a patient's blood.

This study, called CA-CIBLE, is looking into whether adjusting the calcium levels in the blood, specifically *after* it has passed through the CRRT filter, can make a difference. The doctors are wondering if a slightly higher level of calcium in this area might help the filters work better and for longer without getting blocked. They want to make sure that increasing this calcium target doesn't cause any new problems, but instead keeps the filters running smoothly, which is important for patients needing this life-saving treatment.

The main thing the study will measure is how often the filters clot. Researchers will also be checking how long each filter works before it needs to be changed, and why it might have stopped working (for example, if it clotts, or if the patient needs to move). They will also keep a close eye on other things like how much citrate is used, whether calcium levels in the patient’s body remain balanced, and if there are any other changes in important body salts like magnesium or sodium. This information will help doctors understand the best way to use CRRT with citrate to give patients the best possible care.

Key takeaways

  • A study looking at how kidney support treatment (CRRT) can be improved.
  • It tests if a slightly higher blood calcium level after the filter prevents clotting.
  • The main goal is to keep the CRRT filters working longer and more effectively.
  • It's for seriously ill adult patients receiving CRRT in intensive care.
  • Researchers will closely monitor filter life and any body salt imbalances.
  • The study aims to ensure the treatment is safe and at least as good as current methods.

Who may be eligible?

This study is looking for adult patients who are currently in intensive care. To be considered, you must need a specific kidney support treatment called Continuous Renal Replacement Therapy (CRRT) at some point during your stay.

There are no upper age limits, so anyone aged 18 years or older who fits the other criteria can potentially take part. Both men and women are welcome to be considered for this research.

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.

  1. Are you an adult (18 years or older)?
  2. Are you currently in intensive care?
  3. Do you need Continuous Renal Replacement Therapy (CRRT) or are you likely to need it during your stay?
  4. Are you able to participate in a research study (or can your legal representative provide consent)?
  5. Are you comfortable with doctors checking your blood and treatment details regularly?
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 a kidney support treatment called CRRT. The study involves making a small adjustment to the target level of calcium in the blood *after* it goes through the CRRT filter. This adjustment will be done using a standard fluid already available in the hospital called Regiocit. Doctors and nurses will carefully monitor your vital signs, blood test results (especially calcium and other important salts), and how well the CRRT filter is working. They will also track how long the filter lasts and why it might need to be changed.

Most of the information will be gathered from your routine care and blood tests, so there won’t be extra appointments or major changes to your schedule. You will be closely monitored as part of your intensive care treatment, and the study will use this ongoing monitoring to collect its data. The total duration of your participation will depend on how long you need the CRRT treatment.

Potential risks and benefits

Participating in this study might offer a potential benefit by helping to find the best way to prevent CRRT filters from clotting, which could lead to more effective treatment for patients needing kidney support. However, as with any medical treatment, there are potential risks, though the study is investigating a slight adjustment to an existing, standard treatment. Your medical team will monitor you closely for any potential side effects or changes in your health, such as imbalances in other body salts, and will address them immediately. You or your family always have the right to withdraw from the study at any time, for any reason, without affecting your care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    France

Common questions

What is CRRT?

CRRT is a treatment for very sick patients in intensive care whose kidneys aren't working properly. It helps clean their blood, similar to how kidneys do.

What is 'filter thrombosis'?

Filter thrombosis means the CRRT filter gets a blood clot and stops working, so it needs to be replaced. This study aims to reduce that.

What does a 'non-inferiority study' mean?

It means the researchers want to show that the new approach (higher calcium target) is at least as good as the current approach, not worse.

Will I get extra medicines if I join?

The study involves using a specific fluid called Regiocit, which helps with calcium levels, as part of your regular CRRT treatment. It's not an 'extra' medicine outside of your standard care.

Can I leave the study once I've started?

Yes, you or your family can decide to leave the study at any time without it affecting the care you receive.

How to find out more

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

Discussion

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