Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04968587

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

Led by Groupe Hospitalier Sud Ile-de-France · Updated on 2025-06-10

138

Participants Needed

1

Research Sites

195 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • All patients requiring Renal Replacement Therapy
Not Eligible

You will not qualify if you...

  • Age under 18 years
  • Pregnancy
  • Blood calcium level (hypercalcemia) of 3 mmol/L or higher
  • Major under guardianship
  • Major deprived of freedom
  • Unable to provide free and informed consent
  • Presence of bleeding or coagulation disorders
  • Platelet count less than 30 G/L
  • Receiving curative anticoagulation treatment
  • Severe liver disease with Prothrombin rate less than 30%
  • Deficiency in coagulation factors
  • Not registered with a social security system

AI-Screening

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Trial Site Locations

Total: 1 location

1

Groupe Hospitalier Sud Ile-de-France

Melun, France, 77000

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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