Renal Replacement TherapyPhase 3Ca-CIBLENCT05814341
Citrate Anticoagulation in Renal Replacement Therapy: Impact of a High Post-filter Calcium Target on Efficacy
A Phase 3 study testing Citrate in people with Renal Replacement Therapy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Regional citrate anticoagulation (RCA) is the recommended method for anticoagulation in continuous renal replacement therapy (CRRT). However, the optimal post-filter ionized calcium (iCa) target level remains unclear. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Replacement Therapy
- What is being tested?
- Citrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2023to 15 Dec 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- Hospitalized in intensive care and presenting an indication for extra renal replacement therapy with Regional citrate anticoagulation (RCA)
- Patients covered by social security regimen (excepting AME)
- Having given their written consent or, if the patient is unable to consent and is accompanied, written consent from or legal representative or the close relative. If the patient is unable to consent and is not accompanied, due to the urgency of the procedure, the patient can also be included on the decision of the investigator (inclusion procedure in an emergency situation with subsequent necessity to sign a consent to prosecute).
Who cannot join
- Patients receiving curative systemic anticoagulation
- Patients with a contraindication to the use of citrate : - Hypersensitivity to Regiocit®
- Patients with a contraindication to the administration of the ancillary drugs Phoxilium® and calcium chloride
- Patients 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 PT < 30% and lactates > 3mmol/l
- Severe tissue dysoxia in uncontrolled shock with lactic acidosis (lactates > 4mmol/l)
Show all 12Show fewer
- Drug toxicity (metformin, paracetamol, propofol, cyclosporine)
- Pregnant woman
- People under legal protection measure (guardianship or safeguard measures)
- A patient legal representative or the close relative who declined to participate
- Patient deprived of liberty by a judicial or administrative decision
- Patient participating to another interventional study that may have an impact on the evaluation criteria of this study -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Increasing Post-Filter Ionized Target on the Efficacy of Regional Citrate Anticoagulation During Continuous Renal Replacement Therapy in Intensive Care: a Multicenter Randomized Controlled Non-Inferiority Trial
Regional citrate anticoagulation (RCA) is the recommended method for anticoagulation in continuous renal replacement therapy (CRRT). However, the optimal post-filter ionized calcium (iCa) target level remains unclear. Currently, it is titrated to a post-filter iCa target ranging from 0.25 to 0.35 mmol/L, which is derived from a few underpowered trials. There are potential side effects associated with citrate administration, which may be increased in patient with liver failure and/or tissue dysoxia, such as alkalemia, acidemia, hypernatremia, hypocalcemia, hypomagnesemia, and citrate accumulation. Consequently, citrate anticoagulation is contraindicated in the most severe cases. The challenge is to use the minimum necessary dose of citrate to ensure both effective anticoagulation of the circuit and limit citrate administration to reduce the risks of metabolic complications and accumulation. This approach expands the indications for citrate, standardizes practice, and reduces financial costs. Investigators hypothesized that increasing the post-filter iCa target in RCA can limit the dose of citrate, thereby avoiding adverse effects (safety) without compromising the effectiveness of the treatment in preventing filter clotting. The aim of this study is to evaluate the impact of an increased post-filter iCa target from 0.25-0.35 to 0.35-0.45 mmol/L on the incidence of filter clotting for RCA-CRRT in critically ill patients. Investigators are designing a multicenter randomized controlled non-inferiority study.
Read the detailed description
RCA-CRRT will be ordered based on clinical indications and will be performed according to a standardized protocol (available as online supplementary material) in continuous veno-venous hemofiltration mode with the same system (Prismaflex®; Gambro-Baxter, Deerfield, IL, USA) and a 0.9 m2 high-flux AN69 membrane. Blood flow will be maintained between 120 and 180 mL/min according to the patient's ideal body weight. The prescribed dose of filtration will be 30 mL/kg/h to achieve a delivered dose of 20-25 mL/kg/h, following KDIGO guidelines. A citrated replacement solution (Regiocit®; Gambro-Baxter), containing 18.0 mmol/L of citrate, will be delivered continuously to the blood before the filter of the extracorporeal circuit. The rate of infusion of predilution replacement flow will be coupled to the blood flow, aiming for a stable citrate concentration in the extracorporeal circuit. The initial citrate dose will be 3.0 mmol/L of blood, and then citrate flow rate will be adjusted to the post-filter iCa target according to the protocol. Post-filter iCa will be measured on ABL90 FLEX PLUS™ (Radiometer Medical©, Copenhagen, Denmark) blood gas analyzer 15 minutes after any change in dose and then every 6 hours. Calcium chloride will be administered to the patient through a central line to maintain systemic-iCa within 1.00-1.30 mmol/L. Fluid removal rates will be left to the discretion of the attending physician in order to achieve optimal fluid balance. Additionally, metabolic monitoring will be carried out by a blood ionogram every 12 hours. The quantitative parameters will be presented as median and interquartile range [IQR], and comparisons will be made using either Student's t-test or the Mann-Whitney U test depending on whether the assumptions of the t-test are met or not. Categorical data will be reported as the number and percentage (%) and will be compared using Fisher's exact or chi-square test, as appropriate. The incidence of filter clotting will be expressed in absolute values (n) and percentage (%). Comparison between groups will be performed using Pearson's Chi-square test. The analysis of the primary endpoint will be conducted on a per-protocol basis as a first intention (the most conservative approach in a non-inferiority study) and on an intention-to-treat basis. Filter lifespan until clotting curves according to the post-filter iCa2 target will be plotted using the Kaplan-Meier method and compared using the log-rank test.
- Conditions
- Renal Replacement Therapy
- Being tested
- Citrate
- Keywords
- Acute kidney injury, Continuous renal replacement therapy, Regional citrate anticoagulation, Ionized calcium, Intensive care
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CitrateDrug
Also called REGIOCIT®
Comparison of two dosage adjustment protocols for medication according to different post-filter iCa targets
| Study group | Role | What they receive |
|---|---|---|
| High iCa target | Experimental | Post-filter iCa between 0,35-0.45 mmol/L Receives: Drug: Citrate |
| Low iCa target | Active comparator | Post-filter iCa between 0.25-0.35 mmol/L Receives: Drug: Citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of filter clotting
Filter clotting was defined by increased transmembrane pressure greater than 300 mmHg
Measured: 72 hours
Incidence of filter clotting
Filter clotting was defined by visible thrombus in circuit or filter
Measured: 72 hours
Incidence of filter clotting
Filter clotting was defined by inability to rotate the blood pump due to an obstructing thrombus
Measured: 72 hours
Secondary outcomes (13)
Filter lifespan until clotting and filter lifespan, including all causes of stoppage
The lifespan of each hemofilter measured in hours. The cause of CRRT discontinuation will be defined by filter clotting
Measured: 72 hours
Filter lifespan until clotting and filter lifespan, including all causes of stoppage
The lifespan of each hemofilter measured in hours. The cause of CRRT discontinuation will be defined by catheter dysfunction : excessively negative inlet pressure (less than -150mmHg) or excessively positive outlet pressure (greater than +150mmHg)
Measured: 72 hours
Filter lifespan until clotting and filter lifespan, including all causes of stoppage
The lifespan of each hemofilter measured in hours. The cause of CRRT discontinuation will be defined by transport: removal of the patient for mobilization
Measured: 72 hours
Filter lifespan until clotting and filter lifespan, including all causes of stoppage
The lifespan of each hemofilter measured in hours. The cause of CRRT discontinuation will be defined by futility: no indication to continue CRRT
Measured: 72 hours
Filter lifespan until clotting and filter lifespan, including all causes of stoppage
The lifespan of each hemofilter measured in hours. The cause of CRRT discontinuation will be defined by end of session: CRRT has been ongoing for more than 72 hours
Measured: 72 hours
Filter lifespan until clotting and filter lifespan, including all causes of stoppage
The lifespan of each hemofilter measured in hours. The cause of CRRT discontinuation will be defined by citrate accumulation
Measured: 72 hours
Filter lifespan until clotting and filter lifespan, including all causes of stoppage
The lifespan of each hemofilter measured in hours. The cause of CRRT discontinuation will be defined by Intensive Care Unit discharge
Measured: 72 hours
Filter lifespan until clotting and filter lifespan, including all causes of stoppage
The lifespan of each hemofilter measured in hours. The cause of CRRT discontinuation will be defined by death
Measured: 72 hours
Proportion of post-filter iCa in the target range and last psot-filter iCa value before clotting
Post-filter iCa levels (in mmol/L) measured during the CRRT session
Measured: 72 hours
Total dose of citrate infused
Citrate infusion rates, in mmol/day
Measured: 72 hours
Incidence of metabolic events (hypocalcemia, metabolic acidosis, metabolic alkalosis, hypernatremia, hypomagnesemia, citrate accumulation)
The occurrence of the following 6 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]
- Hypernatremia [Na+ > 145mmol/L]
- Hypomagnesemia [Mg2+ < 0.70mmol/L]
- Citrate accumulation [total calcium/ionized calcium ratio > 2.5]
Measured: 72 hours
Financial costs associated with filter changes and citrate use
The costs (in euros) incurred by each filter change and the amount of citrate infused
Measured: 72 hours
Blood loss during the procedure
Inability to return the CRRT circuit at the end of the session (equivalent to 200mL of blood loss)
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start1 Jul 2023
- Primary completion15 Dec 2024
- Study completion15 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal Replacement TherapyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mona ASSEFI, Dr, Principal investigator, Hôpital Pitié Salpêtrière - Assistance Publique Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05814341
- Sponsor's protocol ID
- APHP220257
- Other IDs
- 2022-003678-22
- Acronym
- Ca-CIBLE
- Status last verified
- Jul 2024
- First submitted
- 3 Apr 2023
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Publications
Assefi M, Braik R, James A, Clavieras N, Baron E, Blanchard F, Constantin JM. Impact of increasing post-filter ionised calcium target on regional citrate anticoagulation efficacy in ICU continuous renal replacement therapy: the non-inferiority randomised controlled Ca-CIBLE protocol. BMJ Open. 2024 Sep 26;14(9):e081325. doi: 10.1136/bmjopen-2023-081325.
PubMed 39327056
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Increasing Post-Filter Ionized Target on the Efficacy of Regional Citrate Anticoagulation During Continuous Renal Replacement Therapy in Intensive Care: a Multicenter Randomized Controlled Non-Inferiority Trial
- ClinicalTrials.gov ID
- NCT05814341
- Acronym / sponsor ID
- Ca-CIBLE / APHP220257
- Conditions
- Renal Replacement Therapy
- Keywords
- Acute kidney injury, Continuous renal replacement therapy, Regional citrate anticoagulation, Ionized calcium, Intensive care
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 14 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Regional citrate anticoagulation (RCA) is the recommended method for anticoagulation in continuous renal replacement therapy (CRRT). However, the optimal post-filter ionized calcium (iCa) target level remains unclear. Currently, it is titrated to a post-filter iCa target ranging from 0.25 to 0.35 mmol/L, which is derived from a few underpowered trials. There are potential side effects associated with citrate administration, which may be increased in patient with liver failure and/or tissue dysoxia, such as alkalemia, acidemia, hypernatremia, hypocalcemia, hypomagnesemia, and citrate accumulation. Consequently, citrate anticoagulation is contraindicated in the most severe cases. The challenge is to use the minimum necessary dose of citrate to ensure both effective anticoagulation of the circuit and limit citrate administration to reduce the risks of metabolic complications and accumulation. This approach expands the indications for citrate, standardizes practice, and reduces financial costs. Investigators hypothesized that increasing the post-filter iCa target in RCA can limit the dose of citrate, thereby avoiding adverse effects (safety) without compromising the effectiveness of the treatment in preventing filter clotting. The aim of this study is to evaluate the impact of an increased post-filter iCa target from 0.25-0.35 to 0.35-0.45 mmol/L on the incidence of filter clotting for RCA-CRRT in critically ill patients. Investigators are designing a multicenter randomized controlled non-inferiority study.
Detailed description
RCA-CRRT will be ordered based on clinical indications and will be performed according to a standardized protocol (available as online supplementary material) in continuous veno-venous hemofiltration mode with the same system (Prismaflex®; Gambro-Baxter, Deerfield, IL, USA) and a 0.9 m2 high-flux AN69 membrane. Blood flow will be maintained between 120 and 180 mL/min according to the patient's ideal body weight. The prescribed dose of filtration will be 30 mL/kg/h to achieve a delivered dose of 20-25 mL/kg/h, following KDIGO guidelines. A citrated replacement solution (Regiocit®; Gambro-Baxter), containing 18.0 mmol/L of citrate, will be delivered continuously to the blood before the filter of the extracorporeal circuit. The rate of infusion of predilution replacement flow will be coupled to the blood flow, aiming for a stable citrate concentration in the extracorporeal circuit. The initial citrate dose will be 3.0 mmol/L of blood, and then citrate flow rate will be adjusted to the post-filter iCa target according to the protocol. Post-filter iCa will be measured on ABL90 FLEX PLUS™ (Radiometer Medical©, Copenhagen, Denmark) blood gas analyzer 15 minutes after any change in dose and then every 6 hours. Calcium chloride will be administered to the patient through a central line to maintain systemic-iCa within 1.00-1.30 mmol/L. Fluid removal rates will be left to the discretion of the attending physician in order to achieve optimal fluid balance. Additionally, metabolic monitoring will be carried out by a blood ionogram every 12 hours. The quantitative parameters will be presented as median and interquartile range [IQR], and comparisons will be made using either Student's t-test or the Mann-Whitney U test depending on whether the assumptions of the t-test are met or not. Categorical data will be reported as the number and percentage (%) and will be compared using Fisher's exact or chi-square test, as appropriate. The incidence of filter clotting will be expressed in absolute values (n) and percentage (%). Comparison between groups will be performed using Pearson's Chi-square test. The analysis of the primary endpoint will be conducted on a per-protocol basis as a first intention (the most conservative approach in a non-inferiority study) and on an intention-to-treat basis. Filter lifespan until clotting curves according to the post-filter iCa2 target will be plotted using the Kaplan-Meier method and compared using the log-rank test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High iCa target | Experimental | Drug: CitratePost-filter iCa between 0,35-0.45 mmol/L |
| Low iCa target | Active comparator | Drug: CitratePost-filter iCa between 0.25-0.35 mmol/L |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years old
- Hospitalized in intensive care and presenting an indication for extra renal replacement therapy with Regional citrate anticoagulation (RCA)
- Patients covered by social security regimen (excepting AME)
- Having given their written consent or, if the patient is unable to consent and is accompanied, written consent from or legal representative or the close relative. If the patient is unable to consent and is not accompanied, due to the urgency of the procedure, the patient can also be included on the decision of the investigator (inclusion procedure in an emergency situation with subsequent necessity to sign a consent to prosecute).
Key exclusion criteria (12 listed)
- Patients receiving curative systemic anticoagulation
- Patients with a contraindication to the use of citrate : - Hypersensitivity to Regiocit®
- Patients with a contraindication to the administration of the ancillary drugs Phoxilium® and calcium chloride
- Patients 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:
- Pregnant woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CitrateAlso: REGIOCIT®Comparison of two dosage adjustment protocols for medication according to different post-filter iCa targets | Drug | High iCa target, Low iCa target |
Primary outcome
Incidence of filter clotting
Time frame: 72 hours
Filter clotting was defined by increased transmembrane pressure greater than 300 mmHg
Incidence of filter clotting
Time frame: 72 hours
Filter clotting was defined by visible thrombus in circuit or filter
Incidence of filter clotting
Time frame: 72 hours
Filter clotting was defined by inability to rotate the blood pump due to an obstructing thrombus
13 secondary outcomes
Filter lifespan until clotting and filter lifespan, including all causes of stoppage
Time frame: 72 hours
Filter lifespan until clotting and filter lifespan, including all causes of stoppage
Time frame: 72 hours
Filter lifespan until clotting and filter lifespan, including all causes of stoppage
Time frame: 72 hours
Filter lifespan until clotting and filter lifespan, including all causes of stoppage
Time frame: 72 hours
Filter lifespan until clotting and filter lifespan, including all causes of stoppage
Time frame: 72 hours
Filter lifespan until clotting and filter lifespan, including all causes of stoppage
Time frame: 72 hours
Filter lifespan until clotting and filter lifespan, including all causes of stoppage
Time frame: 72 hours
Filter lifespan until clotting and filter lifespan, including all causes of stoppage
Time frame: 72 hours
Proportion of post-filter iCa in the target range and last psot-filter iCa value before clotting
Time frame: 72 hours
Total dose of citrate infused
Time frame: 72 hours
Incidence of metabolic events (hypocalcemia, metabolic acidosis, metabolic alkalosis, hypernatremia, hypomagnesemia, citrate accumulation)
Time frame: 72 hours
Financial costs associated with filter changes and citrate use
Time frame: 72 hours
Blood loss during the procedure
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Derived from this study: PubMed 39327056Assefi M, Braik R, James A, Clavieras N, Baron E, Blanchard F, Constantin JM. Impact of increasing post-filter ionised calcium target on regional citrate anticoagulation efficacy in ICU continuous renal replacement therapy: the non-inferiority randomised controlled Ca-CIBLE protocol. BMJ Open. 2024 Sep 26;14(9):e081325. doi: 10.1136/bmjopen-2023-081325.
- Individual participant dataSharing planned: Yes. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mona ASSEFI, Dr principal investigator
Hôpital Pitié Salpêtrière - Assistance Publique Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Citrate in people with Renal Replacement Therapy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of filter clotting (time frame: 72 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05814341, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.