Groupe Hospitalier Sud Ile-de-France
Melun, 77000, France
Location status: Recruiting
Location contact
Arezki AGHER
CONTACT
Nathalie Rolin, MD
PRINCIPAL_INVESTIGATOR
Takoua FAYALI
CONTACT
NCT Number: NCT04968587
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Melun, 77000, France
Location status: Recruiting
Arezki AGHER
CONTACT
Nathalie Rolin, MD
PRINCIPAL_INVESTIGATOR
Takoua FAYALI
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Other names: intermittent haemodialysis equipment with lower blood flow and dialysate flow combined with prolonged sessions
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 8 hours
Measurement of the concentration of Mg2+ at the end of 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 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 during each RRT session.
Time frame: Hour 0; 480 minutes
Number of circuit losses during each RRT sessions,
Time frame: Hour 0; 480 minutes
Number of catheter thrombosis during each RRT session
Groupe Hospitalier Sud Ile-de-France
Other
Comparison of Regional Citrate Anticoagulation (RCA) and Regional Anticoagulation by Citrate-Free Decalcification in Renal (RACD) Replacement Therapy Using Sustained Low-Efficiency Dialysis
Acronym: ARDC-SLED
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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