RecruitingNot ApplicableNCT04968587

Comparison of RCA and RACD in Extra-renal Purification by SLED

Comparison of Regional Citrate Anticoagulation (RCA) and Regional Anticoagulation by Citrate-Free Decalcification in Renal (RACD) Replacement Therapy Using Sustained Low-Efficiency Dialysis


Sponsor

Groupe Hospitalier Sud Ile-de-France

Enrollment

138 participants

Start Date

Feb 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

One of the main RRT issues is anticoagulation of the ECC, because blood contact with biomaterials causes bio-incompatibility reactions, including activation of the coagulation cascade. Based on Regional Citrate Anticoagulation (RCA) protocols, an ionized calcium (Ca-ion) concentration around 0.25 to 0.35mmol / L prevents fibrino formation and allows anticoagulation for the ECC. During RCA, metabolic side effects may occur due to systemic flow of citrate. Our postulate is that reduction of ionized calcemia related to the use of a calcium-free dialysate and haemofilter performance makes it possible to avoid citrate infusion. Our study aim to compare intermittent RRT using 4% Citrate infusion and without Citrate.


Eligibility

Min Age: 18 Years

Inclusion Criteria1

  • All patient requiring Renal replacement Therapy

Exclusion Criteria12

  • Age < 18 years
  • Pregnancy
  • Hypercalcemia ≥ 3 mmol/L.
  • Major under guardianship
  • Major deprived of freedom
  • Impossible to obtain free and informed consent
  • Presence of hemostasis or coagulation disorders:
  • Thrombocytopenia < 30 G/L.
  • Curative anticoagulation.
  • Severe liver disease with Prothrombin rate <30%.
  • Coagulation factor deficit.
  • Not registered to a social security system.

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Interventions

PROCEDURESustained Low-Efficiency Dialysis

All patient requiring Renal replacement Therapy in the intensive care unit will be randomized in open order (cross-over) with either Regional anticoagulation with Citrate or Regional anticoagulation by Decalcification without Citrate


Locations(1)

Groupe Hospitalier Sud Ile-de-France

Melun, France

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NCT04968587


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