Comparison of RCA and RACD in Extra-renal Purification by SLED
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sustained Low-Efficiency Dialysis.
- Who it may be relevant to
- Registry conditions: Acute Kidney Injury. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Regional Citrate Anticoagulation (RCA) and Regional Anticoagulation by Citrate-Free Decalcification in Renal (RACD) Replacement Therapy Using Sustained Low-Efficiency Dialysis
Overview
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.
Detailed description
Background: Renal Replacement Therapy (RRT), requires anticoagulation of the extracorporal circuit (ECC) using heparin, citrate or repeated rinsing. Difficulties of implementation or exposition to complications (thrombosis, hemorrhage or electrolyte disorder) are frequent.
Purpose: Regional anticoagulation of the ECC based on ionized calcemia reduction, as using citrate, but induced by the use of a calcium-free dialysate associated with the performance of the hemofilter could reduce these risks and the cost of intermittent RRT. This study aims to compare the efficiency of a regional anticoagulation technique based on the reduction of Ionized Calcium in the extracorporal circuit, without the use of Citrate and with Citrate during intermittent RRT.
Abstract: One of the main RRT issue 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 passage 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 aims at comparing intermittent RRT using 4% Citrate infusion and without Citrate.
Interventions
- Procedure Sustained 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
Primary outcome measures
- Measurement of the plasma urea [Time frame: up to 8 hours]
Secondary outcome measures (7)
- Measurement of the concentration of Ca²+i in post-filter [Time frame: 30 minutes, 1 hour; 4 hours and 8 hours]
- Measurement of the concentration of Ca²+i (patient) [Time frame: 30minutes, 1 hour; 4 hours and 8 hours]
- Measurement of the concentration of Mg2+ [Time frame: 8 hours]
- Measurement of heart rate during each RRT session. [Time frame: Hour 0; 30 minutes; 60 minutes; 90 minutes; 120 minutes; 150 minutes; 180 minutes; 210 minutes; 240 minutes; 270 minutes; 300 minutes; 330 minutes; 360 minutes; 390 minutes; 420 minutes; 450 minutes; 480 minutes]
- Measurement of blood pressure [Time frame: Hour 0; 30 minutes; 60 minutes; 90 minutes; 120 minutes; 150 minutes; 180 minutes; 210 minutes; 240 minutes; 270 minutes; 300 minutes; 330 minutes; 360 minutes; 390 minutes; 420 minutes; 450 minutes; 480 minutes]
- Number of circuit losses during each RRT session, [Time frame: Hour 0; 480 minutes]
- Number of catheter thrombosis during each RRT session [Time frame: Hour 0; 480 minutes]
Eligibility criteria
Inclusion criteria
- All patient requiring Renal replacement Therapy
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
France · 1 center
- Groupe Hospitalier Sud Ile-de-France — Melun
Identifiers
NCT: NCT04968587 · 2020-A0122-37