CA-CIBLE : Impact of increasing the ionized serum calcium target post-filter on the effectiveness of regional citrate anticoagulation during continuous extra-renal purification in intensive care: multicenter randomized controlled non-inferiority study.

Conditions

Adult patients hospitalized in intensive care with an indication of EER with ARC during the stay.

Brief summary

The primary endpoint is the incidence of filter thrombosis (in %).

Detailed description

The lifespan of each hemofilter measured in hours. The cause of the cessation of the EER will be informed among 6 previously defined methods: • Filter thrombosis • Catheter dysfunction: inlet pressure too negative (less than -150mmHg) or outlet pressure too positive (greater than +150mmHg) • Transport: restitution for patient mobilization • Futility: no indication to continue the EER • End of session: EER for more than 72 hours • Other, 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 defined by a hypocalcemia associated with a total calcium/ionized calcium ratio greater than 2.5, The occurrence of the following 5 metabolic complications: • Hypocalcemia [Ca2+ < 0.95mmol/l] • Metabolic acidosis [PH < 7.3 and HCO3- < 20mmol/l] • Metabolic alkalosis [PH > 7.5 and HCO3- > 30mmol/l] • Hypernatraemia [Na+ > 145mmol/l] • Hypomagnesemia [Mg2+ < 0.70mmol/l], The costs (in euros) induced by each hemofilter change and the quantities citrate infused, The impossibility of restoring the EER circuit at the end of the EER session (equivalent 200mL of blood)

Related papers

No related papers found yet.

Interventions

DRUGRegiocit solution pour hémofiltration

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the incidence of filter thrombosis (in %).	—

Secondary

Measure	Time frame
The lifespan of each hemofilter measured in hours. The cause of the cessation of the EER will be informed among 6 previously defined methods: • Filter thrombosis • Catheter dysfunction: inlet pressure too negative (less than -150mmHg) or outlet pressure too positive (greater than +150mmHg) • Transport: restitution for patient mobilization • Futility: no indication to continue the EER • End of session: EER for more than 72 hours • Other, 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 defined by a hypocalcemia associated with a total calcium/ionized calcium ratio greater than 2.5, The occurrence of the following 5 metabolic complications: • Hypocalcemia [Ca2+ < 0.95mmol/l] • Metabolic acidosis [PH < 7.3 and HCO3- < 20mmol/l] • Metabolic alkalosis [PH > 7.5 and HCO3- > 30mmol/l] • Hypernatraemia [Na+ > 145mmol/l] • Hypomagnesemia [Mg2+ < 0.70mmol/l], The costs (in euros) induced	—

Measure

Time frame

The lifespan of each hemofilter measured in hours. The cause of the cessation of the EER will be informed among 6 previously defined methods: • Filter thrombosis • Catheter dysfunction: inlet pressure too negative (less than -150mmHg) or outlet pressure too positive (greater than +150mmHg) • Transport: restitution for patient mobilization • Futility: no indication to continue the EER • End of session: EER for more than 72 hours • Other, 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 defined by a hypocalcemia associated with a total calcium/ionized calcium ratio greater than 2.5, The occurrence of the following 5 metabolic complications: • Hypocalcemia [Ca2+ < 0.95mmol/l] • Metabolic acidosis [PH < 7.3 and HCO3- < 20mmol/l] • Metabolic alkalosis [PH > 7.5 and HCO3- > 30mmol/l] • Hypernatraemia [Na+ > 145mmol/l] • Hypomagnesemia [Mg2+ < 0.70mmol/l], The costs (in euros) induced

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Countries

France

Outcome results

None listed