Critical CarePhase 4PhosphorusNCT04215965
Efficacy and Safety of a Citrate-based Anticoagulation With Calcium-free Phosphate-containing Fluid in Renal Replacement Therapy
A Phase 4 study testing Biphozyl (dialysate and replacement) and Prismocal B22 (dialysate) + phoxilium (replacement) in people with Critical Care, run by Assistance Publique Hopitaux De Marseille.
Trial summary
In the present prospective multicenter RCT we will evaluate the effects on efficacy, acid-base status and serum phosphate levels of a new RCA protocol for Continuous Venovenous Hemodiafiltration (CVVHDF) using an 18 mmol/l citrate solution in combination with a calcium-free phosphate-containing solution, acting as… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Care
- What is being tested?
- Biphozyl (dialysate and replacement) and Prismocal B22 (dialysate) + phoxilium (replacement)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 2 May 2020to 1 Aug 2022
- Phase
- Phase 4
- 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
- Acute renal failure requiring CRRT
- Suitability for regional anticoagulation of the CRRT circuit
- Clinical equipoise regarding the method of circuit anticoagulation
- Subject is affiliated with a social security system (if required by individual country regulations).
- Subject meets national regulatory criteria for clinical trial participation.
- Subject or subject's Legally Authorized Representative (LAR) has signed the study Informed Consent form
Who cannot join
- Age less than 18 years
- Expected stay in ICU less than 24 hours
- Pregnant or breastfeeding
- Suspected ischemic hepatitis or liver failure
- Chronic kidney disease requiring dialysis prior to ICU admission
- As applicable by French law, subject who is a protected individual such as an incompetent adult or incarcerated person
- Metformin and acethaminophen intoxication
Trial locations and contacts
No sites are listed yet.
Lionel VELLY, MD/PhD contact
About this study
Official title: Efficacy and Safety of a Low-citrate-based Anticoagulation With Calcium-free Phosphate-containing Replacement Fluid Compared to Standard Citrate-based Anticoagulation Protocol in Patients Requiring Continuous Renal Replacement Therapy; a Randomized Controlled Trial
In the present prospective multicenter RCT we will evaluate the effects on efficacy, acid-base status and serum phosphate levels of a new RCA protocol for Continuous Venovenous Hemodiafiltration (CVVHDF) using an 18 mmol/l citrate solution in combination with a calcium-free phosphate-containing solution, acting as dialysate and replacement fluid. The new protocol will be introduced with the following targets: a) to refine buffers balance of a previously adopted RCA protocol for Continuous Venovenous Hemofiltration (CVVH), based on a 18 mmol/l citrate solution (Regiocit) combined with calcium and phosphate-free dialysate fluid (PrismOcal B22) and a conventional phosphate-containing replacement fluid (Phoxilium) to prevent CRRT-related phosphate depletion
- Conditions
- Critical Care
- Being tested
- Biphozyl (dialysate and replacement), Prismocal B22 (dialysate) + phoxilium (replacement)
- Keywords
- CRRT, Renal failure, Citrate, Phosphore
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biphozyl (dialysate and replacement)Drug
Replacement solution with phosphate and without calcium in CRRT with citratre-based antigoagulation
Prismocal B22 (dialysate) + phoxilium (replacement)Drug
solution with phosphate and calcium in CRRT with citratre-based antigoagulation
| Study group | Role | What they receive |
|---|---|---|
| Experimental Standard citrate protocol | Experimental | CVVHDF will be performed using Regiocit solution in the predilution mode, Biphozyl in the dialysate and postdilution mode. CRRT will be started at a dose of 35 ml/kg/h. Receives: Drug: Biphozyl (dialysate and replacement) |
| Conventionnal citrate protocol | Active comparator | CVVHDF will be performed using Regiocit solution in the predilution mode, Prismocal B22 (calcium and phosphate free) in the dialysate mode, and Phoxilium in the postdilution mode. CRRT will be started at a dose of 35 ml/kg/h. Receives: Drug: Prismocal B22 (dialysate) + phoxilium (replacement) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circuit lifetime
Number of minutes lifespan circuit
Measured: First 3 days of continous renal replacempent therapy
Secondary outcomes (2)
Efficacy of the new RCA solution
Mean daily delivered RRT dose during the first 3 days of CRRT in ml/kg/h between two groups
Measured: first 3 days of CRRT
Efficacy of the new RCA solution
Percentage of decreasing urea during CRRT course between two groups
Measured: first 3 days of CRRT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start2 May 2020 (estimated)
- Primary completion1 Aug 2021 (estimated)
- Study completion1 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical CareStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emilie GARRIDO, Study director, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04215965
- Sponsor's protocol ID
- 2019-52
- Acronym
- Phosphorus
- Status last verified
- Dec 2019
- First submitted
- 20 Dec 2019
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of a Low-citrate-based Anticoagulation With Calcium-free Phosphate-containing Replacement Fluid Compared to Standard Citrate-based Anticoagulation Protocol in Patients Requiring Continuous Renal Replacement Therapy; a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04215965
- Acronym / sponsor ID
- Phosphorus / 2019-52
- Conditions
- Critical Care
- Keywords
- CRRT, Renal failure, Citrate, Phosphore
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 2 May 2020 (estimated)
- Primary completion
- 1 Aug 2021 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 2 Jan 2020 (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.
In the present prospective multicenter RCT we will evaluate the effects on efficacy, acid-base status and serum phosphate levels of a new RCA protocol for Continuous Venovenous Hemodiafiltration (CVVHDF) using an 18 mmol/l citrate solution in combination with a calcium-free phosphate-containing solution, acting as dialysate and replacement fluid. The new protocol will be introduced with the following targets: a) to refine buffers balance of a previously adopted RCA protocol for Continuous Venovenous Hemofiltration (CVVH), based on a 18 mmol/l citrate solution (Regiocit) combined with calcium and phosphate-free dialysate fluid (PrismOcal B22) and a conventional phosphate-containing replacement fluid (Phoxilium) to prevent CRRT-related phosphate depletion
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Standard citrate protocol | Experimental | Drug: Biphozyl (dialysate and replacement)CVVHDF will be performed using Regiocit solution in the predilution mode, Biphozyl in the dialysate and postdilution mode. CRRT will be started at a dose of 35 ml/kg/h. |
| Conventionnal citrate protocol | Active comparator | Drug: Prismocal B22 (dialysate) + phoxilium (replacement)CVVHDF will be performed using Regiocit solution in the predilution mode, Prismocal B22 (calcium and phosphate free) in the dialysate mode, and Phoxilium in the postdilution mode. CRRT will be started at a dose of 35 ml/kg/h. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Acute renal failure requiring CRRT
- Suitability for regional anticoagulation of the CRRT circuit
- Clinical equipoise regarding the method of circuit anticoagulation
- Subject is affiliated with a social security system (if required by individual country regulations).
- Subject meets national regulatory criteria for clinical trial participation.
Key exclusion criteria (7 listed)
- Age less than 18 years
- Expected stay in ICU less than 24 hours
- Pregnant or breastfeeding
- Suspected ischemic hepatitis or liver failure
- Chronic kidney disease requiring dialysis prior to ICU admission
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 |
|---|---|---|
| Biphozyl (dialysate and replacement)Replacement solution with phosphate and without calcium in CRRT with citratre-based antigoagulation | Drug | Experimental Standard citrate protocol |
| Prismocal B22 (dialysate) + phoxilium (replacement)solution with phosphate and calcium in CRRT with citratre-based antigoagulation | Drug | Conventionnal citrate protocol |
Primary outcome
Circuit lifetime
Time frame: First 3 days of continous renal replacempent therapy
Number of minutes lifespan circuit
2 secondary outcomes
Efficacy of the new RCA solution
Time frame: first 3 days of CRRT
Efficacy of the new RCA solution
Time frame: first 3 days of CRRT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
- Individual participant dataSharing planned: No
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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.
Lionel VELLY, MD/PhD contact
Emilie GARRIDO study director
Assistance Publique Hopitaux De Marseille
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Biphozyl (dialysate and replacement) and Prismocal B22 (dialysate) + phoxilium (replacement) in people with Critical Care, run by Assistance Publique Hopitaux De Marseille.
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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lionel VELLY, MD/PhD (lionel.velly@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circuit lifetime (time frame: First 3 days of continous renal replacempent therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jan 2020.