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Study on the Effectiveness of Sodium Chloride and Sodium Citrate in Intensive Care Patients Undergoing Continuous Kidney Purification

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on patients in intensive care who require a treatment called continuous extra-renal purification. This treatment is often needed when the kidneys are not working well enough to clean the blood. The study is examining the use of a solution called Regiocit, which contains sodium chloride and sodium citrate. These substances help in a process known as regional citrate anticoagulation, which prevents blood from clotting in the machine used for purification.

The purpose of the study is to see if adjusting the levels of ionized calcium in the blood after it passes through the filter can make the treatment just as effective as the current standard levels. The study will compare two different target ranges of ionized calcium to see if one is as good as the other. Patients will receive either the standard treatment or the adjusted treatment, and some may receive a placebo. The study will monitor how well the blood purification works and how long the filters last before they need to be changed.

Throughout the study, researchers will also keep an eye on any side effects, such as changes in calcium levels, and other possible complications like metabolic acidosis or hypocalcemia. The study aims to find the best way to use regional citrate anticoagulation to help patients in intensive care who need this type of blood purification. The trial is expected to continue until mid-2025.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, consent is required. If unable to provide consent, a trusted person or loved one may do so. In urgent situations, the investigator may include the patient with subsequent consent needed to continue.

  2. Step 2

    Treatment initiation

    The study involves the use of a solution called Regiocit, which contains sodium chloride and sodium citrate. This solution is administered through a vein, a process known as intravenous administration.

    The goal is to evaluate the effectiveness of a treatment called regional citrate anticoagulation during a procedure known as continuous extra-renal purification in intensive care.

  3. Step 3

    Monitoring and adjustments

    Throughout the study, the level of calcium in the blood after it passes through a filter is monitored. The target calcium levels are between 0.35-0.45 mmol/l or 0.25-0.35 mmol/l.

    The primary focus is to observe the incidence of filter thrombosis, which is when a blood clot forms in the filter.

  4. Step 4

    Evaluation of outcomes

    The lifespan of each filter used in the procedure is measured in hours. Reasons for stopping the procedure are recorded, such as filter thrombosis, catheter issues, or the end of the session after more than 72 hours.

    Other factors monitored include the rate of citrate infusion, the occurrence of metabolic complications, and the costs associated with filter changes.

  5. Step 5

    Completion of study

    The study is estimated to conclude by July 1, 2025. Participation involves regular monitoring and adjustments as needed to ensure the effectiveness and safety of the treatment.

Who can join the trial?

4 criteria

  • Must be 18 years or older.
  • Currently hospitalized in intensive care with a need for a specific treatment called EER with ARC.
  • Must be enrolled in a social security scheme (state medical aid is not included).
  • Must have given written consent to participate. If the patient cannot give consent, a trusted person or loved one can provide it. In urgent situations, the investigator can decide to include the patient, but consent will be needed later to continue.

Who cannot join the trial?

4 criteria

  • Patients who are not adults cannot participate.
  • Patients who are not hospitalized in intensive care cannot participate.
  • Patients who do not have an indication for EER (Extracorporeal Elimination of Renal) with ARC (Augmented Renal Clearance) during their stay cannot participate.
  • Patients who are part of a vulnerable population cannot participate.
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Investigated drugs

Regional Citrate Anticoagulation (RCA) is a therapy used to prevent blood from clotting in the dialysis circuit during continuous kidney replacement therapy. In this trial, the focus is on adjusting the target levels of ionized calcium in the blood after it passes through the filter. The goal is to see if maintaining a slightly higher level of calcium can still effectively prevent clotting, similar to the standard lower level. This therapy is important for patients in intensive care who need continuous dialysis to support their kidney function.

What is already known about the treatment

Calcium Supplementation – This medication is administered intravenously to adult patients in intensive care who require continuous kidney support and are undergoing a specific type of blood purification called regional citrate anticoagulation (ARC). The current research is exploring its effectiveness in maintaining proper blood clotting during this procedure by adjusting the calcium levels in the blood. The main therapeutic indication is to ensure effective anticoagulation, which means preventing blood clots in the machine used for blood purification. At the molecular level, calcium plays a crucial role in blood clotting processes, and this study aims to find the optimal calcium level to maintain this balance. Calcium supplementation is classified as a mineral supplement, essential for various bodily functions, including bone health and blood clotting.

Investigated diseases

Acute Renal Failure – Acute Renal Failure, also known as Acute Kidney Injury, is a sudden loss of kidney function. It occurs when the kidneys are unable to filter waste products from the blood effectively. This condition can lead to the accumulation of waste products and an imbalance of electrolytes in the body. It often develops rapidly over a few hours or days. The progression can vary, with some cases resolving quickly while others may lead to more severe kidney damage. Factors such as reduced blood flow to the kidneys, direct damage to the kidneys, or blockage of urine flow can contribute to its development.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-511897-64-00Protocol codeAPHP220257Estimated enrolment412 patientsSponsorAssistance Publique Hopitaux De Paris

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