Acute Kidney InjuryCITRA-SAFENCT05313230
Safety and Efficacy of Intermittent Renal Replacement Therapy Using CITRASATE in Critically-ill Patients
An observational study of Acute Kidney Injury and Chronic Kidney Infection, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Renal Replacement Therapy (RRT) needs an extracorporeal circulation to conduct blood to the dialysis membrane and driving back to the patient. This extracorporeal circulation induces inevitably a risk of coagulation activation and premature clotting of the circuit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Chronic Kidney Infection
- What is being tested?
- CITRASATE SLED
- How many people
- 61 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2022to 30 Jun 2022
- Phase
- Observational
- 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
Study population: Patient underwent a RRT in the DAR Lapeyronie (CHU Montpellier) between the 01/01/2019 and the 31/12/2021
Who may be able to join
- Age ≥18 years
- Patient underwent a RRT in the DAR Lapeyronie (CHU Montpellier) between the 01/01/2019 and the 31/12/2021
Who cannot join
- Patient underwent RRT without CITRASATE® protocol
- Lack of data
- Ethical limitation
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Uhmontpellier
Montpellier, Montepllier, 34295
Jonathan CHARBIT, MD, 467338256 ext. 33, j-charbit@chu-montpellier.fr
About this study
Official title: Safety and Efficacy of Intermittent Renal Replacement Therapy Using CITRASATE in Critically-ill Patients: A Retrospective Series
Renal Replacement Therapy (RRT) needs an extracorporeal circulation to conduct blood to the dialysis membrane and driving back to the patient. This extracorporeal circulation induces inevitably a risk of coagulation activation and premature clotting of the circuit. Heparin is thereby commonly used to prevent such thrombosis but exposed patient to risk of hemorrhage. This risk of hemorrhage may be important in ICU population, particularly in severe trauma patients.
The calcium is an important determinant of coagulation cascade. The use of specific citrate enriched dialysate without calcium (CITRASATE®) allows to suddenly lower the calcium concentration in extracorporeal plasma, leading to a regional ineffectiveness of clotting and limited heparin needs. This low calcium plasmatic concentration into the extracorporeal circulation has however to be normalized to not generate a systemic hypocalcemia. In our ICU, a local calcium substitution protocol based on dialysate flow is used in clinical practice.
Read more
Commonly used in our unit, there is a lack data to evaluate the CITRASATE dialysate in a critical population.
The aim goal of our study will be to assess safety and efficacy of intermittent renal replacement therapy using CITRASATE® in critically-ill patients.
Read the detailed description
This is a retrospective descriptive study. The included patients will be those who had a Sustained Low Efficiency Dialysis using CITRASATE® dialysate in CHU Lapeyronie in Montpellier, France between 01/01/2019 and 31/12/2021 Using PMSI code, we estimate that 61 patients could be enrolled in this period and each patient could be almost 6 dialysis session. We estimate we could analyzed 300 to 350 sessions. This sample must be confirmed by the opening of medical records.
A data collection will be focused on the RRT parameters, clinical complications until ICU discharge and outcome, extracted from medical records.
The main endpoint will be to determine the prevalence of ionized calcium troubles (hypocalcemia <0,8 mmol/L or Hypercalcemia >1,4 mmol/L) per and post dialysis using CITRASATE® with our restitution protocol, and their therapeutic consequences.
The secondary endpoints will be to describe the efficacy of CITRASATE® with our restitution protocol during RRT meant by an optimal dialysis dose and the absence of premature clotting of the circuit.
- Conditions
- Acute Kidney Injury, Chronic Kidney Infection
- Being tested
- CITRASATE SLED
- Keywords
- Renal Replacement Therapy, CITRASATE
- 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.
CITRASATE SLEDOther
Applying of CITRASATE SLED
| Study group | Role | What they receive |
|---|---|---|
| CITRASAFE | Patient underwent CITRASATE dialysis session Receives: Other: CITRASATE SLED |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of blood ionized calcium level disorders
Retrospective assessment of the prevalence of ionized calcium troubles (hypocalcemia <0,8 mmol/L or Hypercalcemia >1,4 mmol/L) per and post-dialysis using CITRASATE® with our restitution protocol, and their therapeutic consequences.
Measured: baseline, per dialysis session
change of blood ionized calcium level disorders
Retrospective assessment of the prevalence of ionized calcium troubles (hypocalcemia <0,8 mmol/L or Hypercalcemia >1,4 mmol/L) per and post-dialysis using CITRASATE® with our restitution protocol, and their therapeutic consequences.
Measured: Day 1 (post dialysis session)
Secondary outcomes (3)
Description of therapeutic consequences required
therapeutic consequences required in order to treat the ionized calcium troubles
Measured: day 1
Description of Clotting event
the efficacy of CITRASATE® with our restitution protocol during RRT absence
Measured: day 1
Description of Dialysis dose
the efficacy of CITRASATE® with our restitution protocol during RRT (optimal dialysis dose)
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start1 Feb 2022
- Primary completion1 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 61 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan CHARBIT, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05313230
- Sponsor's protocol ID
- RECHMPL21_0739
- Acronym
- CITRA-SAFE
- Status last verified
- Mar 2022
- First submitted
- 6 Jan 2022
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Intermittent Renal Replacement Therapy Using CITRASATE in Critically-ill Patients: A Retrospective Series
- ClinicalTrials.gov ID
- NCT05313230
- Acronym / sponsor ID
- CITRA-SAFE / RECHMPL21_0739
- Conditions
- Acute Kidney Injury, Chronic Kidney Infection
- Keywords
- Renal Replacement Therapy, CITRASATE
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 61 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 6 Apr 2022 (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.
Renal Replacement Therapy (RRT) needs an extracorporeal circulation to conduct blood to the dialysis membrane and driving back to the patient. This extracorporeal circulation induces inevitably a risk of coagulation activation and premature clotting of the circuit. Heparin is thereby commonly used to prevent such thrombosis but exposed patient to risk of hemorrhage. This risk of hemorrhage may be important in ICU population, particularly in severe trauma patients.
The calcium is an important determinant of coagulation cascade. The use of specific citrate enriched dialysate without calcium (CITRASATE®) allows to suddenly lower the calcium concentration in extracorporeal plasma, leading to a regional ineffectiveness of clotting and limited heparin needs. This low calcium plasmatic concentration into the extracorporeal circulation has however to be normalized to not generate a systemic hypocalcemia. In our ICU, a local calcium substitution protocol based on dialysate flow is used in clinical practice.
Commonly used in our unit, there is a lack data to evaluate the CITRASATE dialysate in a critical population.
The aim goal of our study will be to assess safety and efficacy of intermittent renal replacement therapy using CITRASATE® in critically-ill patients.
Detailed description
This is a retrospective descriptive study. The included patients will be those who had a Sustained Low Efficiency Dialysis using CITRASATE® dialysate in CHU Lapeyronie in Montpellier, France between 01/01/2019 and 31/12/2021 Using PMSI code, we estimate that 61 patients could be enrolled in this period and each patient could be almost 6 dialysis session. We estimate we could analyzed 300 to 350 sessions. This sample must be confirmed by the opening of medical records.
A data collection will be focused on the RRT parameters, clinical complications until ICU discharge and outcome, extracted from medical records.
The main endpoint will be to determine the prevalence of ionized calcium troubles (hypocalcemia <0,8 mmol/L or Hypercalcemia >1,4 mmol/L) per and post dialysis using CITRASATE® with our restitution protocol, and their therapeutic consequences.
The secondary endpoints will be to describe the efficacy of CITRASATE® with our restitution protocol during RRT meant by an optimal dialysis dose and the absence of premature clotting of the circuit.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CITRASAFE | – | Other: CITRASATE SLEDPatient underwent CITRASATE dialysis session |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient underwent a RRT in the DAR Lapeyronie (CHU Montpellier) between the 01/01/2019 and the 31/12/2021
Key inclusion criteria (2 listed)
- Age ≥18 years
- Patient underwent a RRT in the DAR Lapeyronie (CHU Montpellier) between the 01/01/2019 and the 31/12/2021
Key exclusion criteria (3 listed)
- Patient underwent RRT without CITRASATE® protocol
- Lack of data
- Ethical limitation
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 |
|---|---|---|
| CITRASATE SLEDApplying of CITRASATE SLED | Other | CITRASAFE |
Primary outcome
change of blood ionized calcium level disorders
Time frame: baseline, per dialysis session
Retrospective assessment of the prevalence of ionized calcium troubles (hypocalcemia <0,8 mmol/L or Hypercalcemia >1,4 mmol/L) per and post-dialysis using CITRASATE® with our restitution protocol, and their therapeutic consequences.
change of blood ionized calcium level disorders
Time frame: Day 1 (post dialysis session)
Retrospective assessment of the prevalence of ionized calcium troubles (hypocalcemia <0,8 mmol/L or Hypercalcemia >1,4 mmol/L) per and post-dialysis using CITRASATE® with our restitution protocol, and their therapeutic consequences.
3 secondary outcomes
Description of therapeutic consequences required
Time frame: day 1
Description of Clotting event
Time frame: day 1
Description of Dialysis dose
Time frame: day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Individual participant dataSharing planned: Undecided. NC
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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.
Jonathan CHARBIT, MD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and Chronic Kidney Infection, run by University Hospital, Montpellier 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 2 inclusion and 3 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 6 Apr 2022. 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.
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 Jonathan CHARBIT, MD (467338256 ext. 33, j-charbit@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of blood ionized calcium level disorders (time frame: baseline, per dialysis session). The study lists 2 primary outcomes in all. 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 6 Apr 2022.