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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.
EU CTIS ID: 2024-511897-64-00
What this study is testing
Demonstrate that a post-filter Ca2+ target between 0.35-0.45mmol/l allows a anticoagulation of the circuit with efficiency comparable to a post-filter Ca2+ target between 0.25-0.35mmol/l, during an EER with ARC in intensive care.
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Aged 18 or older
- Hospitalized in intensive care and presenting an indication of EER with ARC
- Affiliate to a social security scheme or entitled to (state medical aid excluded)
- Having given their written consent or in the event that the patient is unfit to consent and is accompanied, collection of written consent from the person trusted or a loved one. If the patient is unable to consent and the absence of an accompanying 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 continue).
You likely can't join if
- Patient benefiting from systemic curative anticoagulation
- Patient with a contraindication to Regiocit®: hypersensitivity to investigational medicinal product or one of its excipients, hepatic insufficiency severe or shock with muscle hypoperfusion
- Patient with a contraindication to the administration of medications auxiliaries Phoxilium® and calcium chloride
- Patient with an absolute contraindication to the use of citrate by default of metabolism at the level of the Krebs cycle and therefore major risk accumulation: • Severe impairment of liver function with TP < 30% and lactates > 3mmol/l • Major tissue dysoxia in uncontrolled shock with acidosis lactic (lactates > 4mmol/l) • Drug poisonings (metformin, paracetamol, propofol, cyclosporin)
- Pregnant woman
- Protected adult (guardianship or curatorship)
See the full eligibility criteria
- Aged 18 or older
- Hospitalized in intensive care and presenting an indication of EER with ARC
- Affiliate to a social security scheme or entitled to (state medical aid excluded)
- Having given their written consent or in the event that the patient is unfit to consent and is accompanied, collection of written consent from the person trusted or a loved one. If the patient is unable to consent and the absence of an accompanying 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 continue).
- Patient benefiting from systemic curative anticoagulation
- Patient with a contraindication to Regiocit®: hypersensitivity to investigational medicinal product or one of its excipients, hepatic insufficiency severe or shock with muscle hypoperfusion
- Patient with a contraindication to the administration of medications auxiliaries Phoxilium® and calcium chloride
- Patient with an absolute contraindication to the use of citrate by default of metabolism at the level of the Krebs cycle and therefore major risk accumulation: • Severe impairment of liver function with TP < 30% and lactates > 3mmol/l • Major tissue dysoxia in uncontrolled shock with acidosis lactic (lactates > 4mmol/l) • Drug poisonings (metformin, paracetamol, propofol, cyclosporin)
- Pregnant woman
- Protected adult (guardianship or curatorship)
- Refusal of participation by the patient or their loved one/trusted person
- Patient deprived of liberty by a judicial or administrative decision
- Patient included in another interventional trial that may have an impact on the evaluation criteria of the present study
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.