Using citrate anticoagulation in kidney treatment to improve patient outcomes
The Effect of Increasing Post-Filter Ionized Target on the Efficacy of Regional Citrate Anticoagulation During Continuous Renal Replacement Therapy in Intensive Care: a Multicenter Randomized Controlled Non-Inferiority Trial
This study tests if using a specific type of blood thinner called citrate during kidney treatment can help patients with acute kidney injury feel better while keeping their calcium levels safe.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 412 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT05814341 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of regional citrate anticoagulation (RCA) in continuous renal replacement therapy (CRRT) for patients with acute kidney injury. The study aims to determine the optimal post-filter ionized calcium target level to enhance the efficacy of anticoagulation while minimizing potential side effects associated with citrate administration. Patients will receive a standardized protocol for RCA-CRRT, with careful monitoring and adjustments made to maintain appropriate calcium levels. The trial seeks to expand the indications for citrate use and standardize practices in intensive care settings.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are hospitalized in intensive care and require extra renal replacement therapy with RCA.
Not a fit: Patients who are receiving curative systemic anticoagulation or have contraindications to citrate will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve the safety and effectiveness of anticoagulation in patients undergoing renal replacement therapy.
How similar studies have performed: Other studies have explored citrate anticoagulation, but this trial aims to refine its application, making it a potentially novel approach.
Eligibility criteria
Show full inclusion / exclusion 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 -
Where this trial is running
Paris
- Hospital Pitie Salpetriere — Paris, France (Recruiting)
Study contacts
- Principal investigator: Mona ASSEFI, Dr — Hôpital Pitié Salpêtrière - Assistance Publique Hôpitaux de Paris
- Study coordinator: Mona ASSEFI, Dr
- Email: mona.assefi@aphp.fr
- Phone: 01 84 82 73 59
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.