Acute Kidney Injury
Conditions
Brief 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.
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
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
Sponsors
Groupe Hospitalier Sud Ile-de-France
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of the plasma urea | up to 8 hours | We will compare plasma urea clearance after reaching the prescribed session time without irreversible coagulation of the extracorporeal circuit, with both methods tested in the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of the concentration of Ca²+i (patient) | 30minutes, 1 hour; 4 hours and 8 hours | Measurement at different timepoints after the beginning of the concentration of Ca²+i (patient) during each RRT session. |
| Measurement of the concentration of Mg2+ | 8 hours | Measurement of the concentration of Mg2+ at the end of each RRT session. |
| Measurement of heart rate during each RRT session. | 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 heart rate during each RRT session. |
| Measurement of the concentration of Ca²+i in post-filter | 30 minutes, 1 hour; 4 hours and 8 hours | Measurement at different timepoints after the beginning of the concentration of Ca²+i in post-filter during each RRT session. |
| Number of circuit losses during each RRT session, | Hour 0; 480 minutes | Number of circuit losses during each RRT sessions, |
| Number of catheter thrombosis during each RRT session | Hour 0; 480 minutes | Number of catheter thrombosis during each RRT session |
| Measurement of blood pressure | 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 during each RRT session. |
Countries
France
Outcome results
None listed