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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

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Other Sites

Site Name City Country Status
Hopitaux Universitaires Pitie Salpetriere Paris France
Hopital Beaujon Clichy France
Aklornkmhx Ptwwwhlc Haiyixfc Dm Pprra Paris France
Uiyijqbzjc Hcnydsxbr Pospt Srgvywpqiwe Cltdivr Fvaz Paris France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
01.07.2023

Trial locations

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.

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 ID:
2024-511897-64-00
Protocol code:
APHP220257
Trial Phase:
Human Pharmacology (Phase I) – Other

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