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.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Assistance Publique Hopitaux De Paris

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]

Trial duration

1 Jul 2023 → 31 Dec 2024

Decision date (initial)

2024-10-25

Transition trial

Yes

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-511897-64-00

EudraCT number

2022-003678-22

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

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.

Secondary objectives 9

1. Compare between the two groups the lifespan of hemofilters, up to filter thrombosis
2. Compare between the two groups the lifespan of hemofilters, all causes of stoppage combined
3. Compare between the two groups the last post-filter Ca2+ value before thrombosis
4. Compare between the two groups the proportion of post-filter Ca2+ in the objectives
5. Compare between the two groups the total dose of citrate infused
6. Compare between the two groups the incidence of suspected citrate accumulation syndrome
7. Compare between the two groups the incidence of metabolic events (hypocalcemia, acidosis metabolic, metabolic alkalosis, hypernatremia, hypomagnesemia)
8. Compare between the two groups the financial costs of filter changes and citrate
9. Compare between the two groups Blood theft

Conditions and MedDRA coding

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

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Aged 18 or older
2. Hospitalized in intensive care and presenting an indication of EER with ARC
3. Affiliate to a social security scheme or entitled to (state medical aid excluded)
4. 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).

Exclusion criteria 9

1. Patient benefiting from systemic curative anticoagulation
2. Patient with a contraindication to Regiocit®: hypersensitivity to investigational medicinal product or one of its excipients, hepatic insufficiency severe or shock with muscle hypoperfusion
3. Patient with a contraindication to the administration of medications auxiliaries Phoxilium® and calcium chloride
4. 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)
5. Pregnant woman
6. Protected adult (guardianship or curatorship)
7. Refusal of participation by the patient or their loved one/trusted person
8. Patient deprived of liberty by a judicial or administrative decision
9. Patient included in another interventional trial that may have an impact on the evaluation criteria of the present study

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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

Secondary endpoints 7

1. 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
2. Post-filter Ca2+ (in mmol/l) measured during the EER session
3. Citrate infusion rates (PPS) in mmol/l
4. The incidence of suspected citrate accumulation syndrome defined by a hypocalcemia associated with a total calcium/ionized calcium ratio greater than 2.5
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]
6. The costs (in euros) induced by each hemofilter change and the quantities citrate infused
7. The impossibility of restoring the EER circuit at the end of the EER session (equivalent 200mL of blood)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Assistance Publique Hopitaux De Paris

Sponsor organisation

Assistance Publique Hopitaux De Paris

Address

Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux

City

Paris Cedex 10

Postcode

75475

Country

France

Scientific contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Stanislas Quenard

Public contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Stanislas Quenard

Locations

1 EU/EEA country · 7 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 11 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications