Acute Renal FailureNCT04062812
New Protocol With Diluted Citrate in Continuous Techniques
A study testing the same citrate dosification in both types in people with Acute Renal Failure and Dialysis; Complications, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
The investigators designed a monitoring and control table of a citrate treatment on a specific monitor. This is the Baxter "Prismaflex" monitor, with 8.2 software version. Dialysis bath liquids marketed by Baxter: Biphozyl are used. Citrate liquid (1:18) Regiocit is used. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Renal Failure, Dialysis; Complications, Citrate Poisoning
- What is being tested?
- the same citrate dosification in both types
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSpain
- Study dates
- 1 Aug 2019to 20 Dec 2021
- Phase
- Interventional
- 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
- Adult patients (regardless of their underlying pathology), who develop acute renal failure, admitted to the ICU of St Pau with the medical team of Intensive Medicine, who require anticoagulation with citrate in continuous dialysis therapy and are treated with the Baxter monitor.
Who cannot join
- parenteral nutrition
- pregnancy
- cardiac surgery
- coronary patients
Trial locations and contacts
1 site in 1 country.
Spain1 site
Fundació de Gestió Sanitària de l'Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
About this study
Official title: Comparison of Diluted vs Concentrated Regional Citrate Anticoagulation in Continuous Renal Replacement Therapy: A Quasi-experimental Study
The investigators designed a monitoring and control table of a citrate treatment on a specific monitor. This is the Baxter "Prismaflex" monitor, with 8.2 software version. Dialysis bath liquids marketed by Baxter: Biphozyl are used. Citrate liquid (1:18) Regiocit is used.
The dialysis treatment monitor (CVVHD) is programmed, with a blood / citrate pumps at a rate of 1:10 (1 ml / min of blood: 10 ml / h of dialysis fluid) The starting dose of citrate will be 3.5 mmol / l and the calcium compensation will be 100% Working hypothesis: The patient undergoing citrate anticoagulation according to the designed algorithm will respond with ion stability and pH during the treatment, in addition to achieving an effective cleaning process.
Read the detailed description
Study design: quasi-experimental design. two groups:
- Usual protocol with Multifiltrate monitor and citrate (136 mmol/l)
- Intervention group. New protocol with Prismaflex monitor and citrate (18 mmol/l)
Study population Inclusión/exclusion criteria:
Adult patients (regardless of their underlying pathology), who develop acute renal failure, admitted to the ICU of St Pau Hospital with the Intensive Medicine medical team, who require citrate anticoagulation in continuous dialysis therapy and are treated with Baxter "Prismaflex" monitor.
Patients who meet the criteria described above will be followed up in this study.
Expected sample size:
It is estimated that with 24/12 (group1/2) patients will be enough to achieve our goal
Methodology. Information sources:
The start of the treatment with Baxter citrate will be given according to the patient's need and subject to a basic medical decision. From here the research team will enter. The investigation team will never influence the medical decision.
Since such a treatment is started, the main investigator will assign a number to the dialysis circuit and will be followed, every six hours, for the most important variables. The rest of the variables will be collected at least once a day and according to the patient's situation.
- Being tested
- the same citrate dosification in both types
- Keywords
- sodium citrate, calcaemia, magnesium, phosphorus, ionic calcium
- 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.
the same citrate dosification in both typesOther
match concentrated and dilute citrate protocol
| Study group | Role | What they receive |
|---|---|---|
| Diluted citrate | Experimental | Initial citrate dose 3.5 mmol/L Initial calcium programmed 100% ("compensation dose") only dialysis and ratio 1:10 (blood/dialysis) No fluids in the repositioning scale Receives: Other: the same citrate dosification in both types |
| Concentrated citrate | Active comparator | Initial citrate dose: 3.5 mmol/L Initial calcium dose: 1.9 mmol/L and 1:20 ratio (blood/dialysis) No convection programmed Receives: Other: the same citrate dosification in both types |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dialysis flow
Speed at which the dialysis fluid pump is programmed in the circuit and measured in milliliters / hour
Measured: 6 hours
Blood flow
Speed at which the blood pump is programmed in the dialysis circuit and measured in milliliters / min
Measured: 6 hours
Citrate dose
Relationship that exists between the liquid we infuse (which contains 18mmol / L citrate) and the blood pump. It is measured in mmol citrate / liter of blood
Measured: 6 hours
Calcium dose
Amount of calcium that is replenished to the patient when the dialyzed blood is returned. It is measured in%.
Measured: 6 hours
Secondary outcomes (15)
Filter operating hours
They correspond to the hours that go from the beginning of the circuit until the end of the circuit in which the fungible is discarded. It can be several days
Measured: number of hours
Arterial pH
Corresponds to the patient's arterial blood pH figure at the time of observation
Measured: 6 hours
Arterial bicarbonate
It is the bicarbonate figure found in arterial blood. It is measured in mmol / l.
Measured: 6 hours
Post-filter ionic calcium
Corresponds to the value of ionic calcium by taking the sample at the blood outlet of the dialysis filter. It is measured in mmol / l.
Measured: 6 hours
Ionic Calcium Patien
It is the ionic calcium value of the patient in a systemic way, preferably arterial. It is measured in mmol / l
Measured: 6 hours
Total calcium
Total calcium value. It is measured in mmol / l
Measured: 6 hours
Total Ca / Ionic Ca Ratio
Relationship between the total calcium and the ionic one of the patient
Measured: 24 hours
Match
Value of this ion in the patient. It is measured in mmol / l.
Measured: 24 hours
Magnesium
Value of this ion in the patient. It is measured in mmol / l.
Measured: 24 hours
Sodium
Value of this ion in the patient. It is measured in mmol / l.
Measured: 24 hours
Potassium
Value of this ion in the patient. It is measured in mmol / l.
Measured: 24 hours
Urea
Urea level of the patient at the time of observation
Measured: 24 hours
Creatinine
Creatinine level of the patient at the time of observation
Measured: 24 hours
INR
INR level of the patient at the time of observation
Measured: 24 hours
Lactate
Lactate level of the patient at the time of observation
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2019
- Study start1 Aug 2019
- Primary completion1 Oct 2021
- Study completion20 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Renal FailureStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Quasi-experimental design
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04062812
- Sponsor's protocol ID
- IIBSP-CIT-2019-34
- Status last verified
- Feb 2023
- First submitted
- 6 Aug 2019
- Last updated
- 12 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Diluted vs Concentrated Regional Citrate Anticoagulation in Continuous Renal Replacement Therapy: A Quasi-experimental Study
- ClinicalTrials.gov ID
- NCT04062812
- Acronym / sponsor ID
- IIBSP-CIT-2019-34
- Keywords
- sodium citrate, calcaemia, magnesium, phosphorus, ionic calcium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 20 Aug 2019 (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.
The investigators designed a monitoring and control table of a citrate treatment on a specific monitor. This is the Baxter "Prismaflex" monitor, with 8.2 software version. Dialysis bath liquids marketed by Baxter: Biphozyl are used. Citrate liquid (1:18) Regiocit is used.
The dialysis treatment monitor (CVVHD) is programmed, with a blood / citrate pumps at a rate of 1:10 (1 ml / min of blood: 10 ml / h of dialysis fluid) The starting dose of citrate will be 3.5 mmol / l and the calcium compensation will be 100% Working hypothesis: The patient undergoing citrate anticoagulation according to the designed algorithm will respond with ion stability and pH during the treatment, in addition to achieving an effective cleaning process.
Detailed description
Study design: quasi-experimental design. two groups:
- Usual protocol with Multifiltrate monitor and citrate (136 mmol/l)
- Intervention group. New protocol with Prismaflex monitor and citrate (18 mmol/l)
Study population Inclusión/exclusion criteria:
Adult patients (regardless of their underlying pathology), who develop acute renal failure, admitted to the ICU of St Pau Hospital with the Intensive Medicine medical team, who require citrate anticoagulation in continuous dialysis therapy and are treated with Baxter "Prismaflex" monitor.
Patients who meet the criteria described above will be followed up in this study.
Expected sample size:
It is estimated that with 24/12 (group1/2) patients will be enough to achieve our goal
Methodology. Information sources:
The start of the treatment with Baxter citrate will be given according to the patient's need and subject to a basic medical decision. From here the research team will enter. The investigation team will never influence the medical decision.
Since such a treatment is started, the main investigator will assign a number to the dialysis circuit and will be followed, every six hours, for the most important variables. The rest of the variables will be collected at least once a day and according to the patient's situation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Quasi-experimental design
| Arm | Type | Receives |
|---|---|---|
| Diluted citrate | Experimental | Other: the same citrate dosification in both typesInitial citrate dose 3.5 mmol/L Initial calcium programmed 100% ("compensation dose") only dialysis and ratio 1:10 (blood/dialysis) No fluids in the repositioning scale |
| Concentrated citrate | Active comparator | Other: the same citrate dosification in both typesInitial citrate dose: 3.5 mmol/L Initial calcium dose: 1.9 mmol/L and 1:20 ratio (blood/dialysis) No convection programmed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients (regardless of their underlying pathology), who develop acute renal failure, admitted to the ICU of St Pau with the medical team of Intensive Medicine, who require anticoagulation with citrate in continuous dialysis therapy and are treated with the Baxter monitor.
Key exclusion criteria (4 listed)
- parenteral nutrition
- pregnancy
- cardiac surgery
- coronary patients
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 |
|---|---|---|
| the same citrate dosification in both typesmatch concentrated and dilute citrate protocol | Other | Concentrated citrate, Diluted citrate |
Primary outcome
Dialysis flow
Time frame: 6 hours
Speed at which the dialysis fluid pump is programmed in the circuit and measured in milliliters / hour
Blood flow
Time frame: 6 hours
Speed at which the blood pump is programmed in the dialysis circuit and measured in milliliters / min
Citrate dose
Time frame: 6 hours
Relationship that exists between the liquid we infuse (which contains 18mmol / L citrate) and the blood pump. It is measured in mmol citrate / liter of blood
Calcium dose
Time frame: 6 hours
Amount of calcium that is replenished to the patient when the dialyzed blood is returned. It is measured in%.
15 secondary outcomes
Filter operating hours
Time frame: number of hours
Arterial pH
Time frame: 6 hours
Arterial bicarbonate
Time frame: 6 hours
Post-filter ionic calcium
Time frame: 6 hours
Ionic Calcium Patien
Time frame: 6 hours
Total calcium
Time frame: 6 hours
Total Ca / Ionic Ca Ratio
Time frame: 24 hours
Match
Time frame: 24 hours
Magnesium
Time frame: 24 hours
Sodium
Time frame: 24 hours
Potassium
Time frame: 24 hours
Urea
Time frame: 24 hours
Creatinine
Time frame: 24 hours
INR
Time frame: 24 hours
Lactate
Time frame: 24 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 12 Jan 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the same citrate dosification in both types in people with Acute Renal Failure and Dialysis; Complications, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 1 inclusion and 4 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 12 Jan 2024. 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 Spain. 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?
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?
Dialysis flow (time frame: 6 hours). The study lists 4 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 12 Jan 2024.