Adult patients hospitalized in intensive care with an indication of RRT with ARC during the stay.
Conditions
Interventions
Trade Name: REGIOCIT
Pharmaceutical Form:
Sponsors
ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS (APHP)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Aged 18 or older - Hospitalized in intensive care and presenting an indication of EER with ARC - Affiliated to a social security scheme or eligible (state medical aid excluded) Having given their written consent or in the case where the patient is unable to consent and is accompanied, obtaining the written consent of the trusted person or a relative. In the event of the patient's inability to consent and the absence of a support person, due to the urgent nature of the procedure, the patient may also be included on the sole decision of the investigator (inclusion procedure in an emergency situation with subsequent need for consent to prosecute). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 412 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 412
Exclusion criteria
Exclusion criteria: - Patient receiving systemic curative anticoagulation - Patient with a contraindication to Regiocit®: hypersensitivity to the experimental drug or to one of its excipients, severe hepatic impairment or shock with muscle hypoperfusion - Patient with a contraindication to the administration of the auxiliary drugs Phoxilium® and Calcium chloride - Patient with an absolute contraindication to the use of citrate due to a lack of metabolism in the Krebs cycle and therefore a major risk of accumulation: • Severe impairment of liver function with TP 3mmol/l • Major tissue dysoxia on uncontrolled state of shock with lactic acidosis (lactates > 4mmol/l) • Drug poisoning (metformin, paracetamol, propofol, ciclosporin) - Pregnant woman - Protected adult (tutorship or curatorship) - Refusal to participate by the patient or his relative/person of trust - Patient deprived of liberty by a judicial or administrative decision - Patient included in another interventional trial that may have an impact on the endpoints of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Demonstrate that a post-filter Ca2+ target between 0.35-0.45mmol/l allows anticoagulation of the circuit with efficacy comparable to a post-filter Ca2+ target between 0.25-0.35mmol/l, during of an EER with ARC in intensive care.;Secondary Objective: Compare between the two groups: - The lifespan of hemofilters, until filter thrombosis - The lifespan of hemofilters, all causes of stoppage combined - The last post-filter Ca2+ value before thrombosis - The proportion of post-filter Ca2+ in the lenses - The total dose of citrate infused - The incidence of suspected citrate accumulation syndrome - The incidence of metabolic events (hypocalcemia, metabolic acidosis, metabolic alkalosis, hypernatremia, hypomagnesemia) - Financial costs induced by filter changes and citrate - blood spoliation;Primary end point(s): The primary endpoint is the incidence of filter thrombosis (in %). Filter thrombosis is defined by one of the following criteria: - Increase in transmembrane pressure greater than 300mmHg - Visible thrombus in the EER circuit or filter - Inability to rotate the blood pump due to an obstructing thrombus All causes of RRT discontinuation will be reassessed independently by two clinicians. The termination of the session will be attributed to filter thrombosis, if the assessment of the two clinicians is concordant.;Timepoint(s) of evaluation of this end point: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - The lifetime of each hemofilter measured in hours. The reason for stopping the EER will be indicated among 6 previously defined methods: • Filter thrombosis • Catheter dysfunction: inlet pressure too negative (lower than -150mmHg) or outlet pressure too positive (greater than +150mmHg) • Transport: restitution for patient mobilization • Futility: no indication to continue the RE • End of session: EER for more than 72 hours • Other - The post-filter Ca2+ (in mmol/l) measured during the EER session - Citrate infusion rates (PPS) in mmol/l - The incidence of suspected citrate accumulation syndrome is defined by hypocalcemia associated with a ratio of total serum calcium to ionized serum calcium greater than 2.5 - The occurrence of the following 5 metabolic complications: • Hypocalcaemia [Ca2+ 7.5 and HCO3- > 30mmol/l] • Hypernatremia [Na+ > 145mmol/l] • Hypomagnesemia [Mg2+ < 0.70mmol/l] - The costs (in euros) induced by each change of hemofilter and the quantities of citrate infused The impossibility of restoring the EER circuit at the end of the EER session (equivalent to 200mL of blood) ;Timepoint(s) of evaluation of this end point: 3 months | — |
Countries
France
Contacts
Public ContactPôle Promotion - DRCI
ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS (AP-HP)
Outcome results
None listed