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Search / Trial NCT05814341

Citrate Anticoagulation in Renal Replacement Therapy: Impact of a High Post-filter Calcium Target on Efficacy

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Apr 3, 2023

Trial Information

Current as of July 24, 2025

Recruiting

Keywords

Acute Kidney Injury Continuous Renal Replacement Therapy Regional Citrate Anticoagulation Ionized Calcium Intensive Care

ClinConnect Summary

This clinical trial is studying a new approach to using citrate anticoagulation during a treatment called continuous renal replacement therapy (CRRT), which is often needed for critically ill patients whose kidneys are not working properly. The researchers want to find out if setting a higher target level of calcium in the blood after the filter (between 0.35 and 0.45 mmol/L) can help reduce the amount of citrate needed while still effectively preventing the filter from clotting. This is important because using less citrate may lower the risk of side effects, which can be a concern for some patients.

To participate in the trial, you must be at least 18 years old and currently in an intensive care unit needing this type of kidney treatment. You should also be able to provide consent or have a representative who can give consent on your behalf. However, not everyone can join; for instance, if you are already on other anticoagulant medications or have severe liver problems, you would be excluded. If you decide to participate, you can expect close monitoring while receiving treatment to help ensure your safety and the effectiveness of this new approach.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Age ≥ 18 years old
  • 2. Hospitalized in intensive care and presenting an indication for extra renal replacement therapy with Regional citrate anticoagulation (RCA)
  • 3. Patients covered by social security regimen (excepting AME)
  • 4. Having given their written consent or, if the patient is unable to consent and is accompanied, written consent from or legal representative or the close relative. If the patient is unable to consent and is not accompanied, due to the urgency of the procedure, the patient can also be included on the decision of the investigator (inclusion procedure in an emergency situation with subsequent necessity to sign a consent to prosecute).
  • Exclusion Criteria:
  • 1. Patients receiving curative systemic anticoagulation
  • 2. Patients with a contraindication to the use of citrate : - Hypersensitivity to Regiocit®
  • 3. Patients with a contraindication to the administration of the ancillary drugs Phoxilium® and calcium chloride
  • 4. Patients with an absolute contraindication to the use of citrate due to a lack of metabolism in the Krebs cycle and therefore a major risk of accumulation:
  • Severe impairment of liver function with PT \< 30% and lactates \> 3mmol/l
  • Severe tissue dysoxia in uncontrolled shock with lactic acidosis (lactates \> 4mmol/l)
  • Drug toxicity (metformin, paracetamol, propofol, cyclosporine)
  • 5. Pregnant woman
  • 6. People under legal protection measure (guardianship or safeguard measures)
  • 7. A patient legal representative or the close relative who declined to participate
  • 8. Patient deprived of liberty by a judicial or administrative decision
  • 9. Patient participating to another interventional study that may have an impact on the evaluation criteria of this study -

About Assistance Publique Hôpitaux De Paris

Assistance Publique - Hôpitaux de Paris (AP-HP) is a leading public hospital system in France, renowned for its commitment to healthcare excellence and innovative medical research. As a prominent clinical trial sponsor, AP-HP plays a pivotal role in advancing medical knowledge and improving patient care through rigorous scientific investigations across a wide range of therapeutic areas. With a focus on collaboration and interdisciplinary approaches, AP-HP leverages its extensive network of hospitals and expert clinicians to facilitate high-quality clinical trials that adhere to the highest ethical and regulatory standards, ultimately aiming to translate research findings into tangible health benefits for diverse patient populations.

Locations

Paris, , France

Patients applied

0 patients applied

Trial Officials

Mona ASSEFI, Dr

Principal Investigator

Hôpital Pitié Salpêtrière - Assistance Publique Hôpitaux de Paris

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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