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Completed

NCT Number: NCT04062812

New Protocol With Diluted Citrate in Continuous Techniques

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fundació de Gestió Sanitària de l'Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • parenteral nutrition
  • pregnancy
  • cardiac surgery
  • coronary patients

Treatment and study plan

the same citrate dosification in both types

Other

match concentrated and dilute citrate protocol

Primary outcomes

  1. Dialysis flow

    Time frame: 6 hours

    Speed at which the dialysis fluid pump is programmed in the circuit and measured in milliliters / hour

  2. Blood flow

    Time frame: 6 hours

    Speed at which the blood pump is programmed in the dialysis circuit and measured in milliliters / min

  3. 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

  4. 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%.

Secondary outcomes

  1. Filter operating hours

    Time frame: number of 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

  2. Arterial pH

    Time frame: 6 hours

    Corresponds to the patient's arterial blood pH figure at the time of observation

  3. Arterial bicarbonate

    Time frame: 6 hours

    It is the bicarbonate figure found in arterial blood. It is measured in mmol / l.

  4. Post-filter ionic calcium

    Time frame: 6 hours

    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.

  5. Ionic Calcium Patien

    Time frame: 6 hours

    It is the ionic calcium value of the patient in a systemic way, preferably arterial. It is measured in mmol / l

  6. Total calcium

    Time frame: 6 hours

    Total calcium value. It is measured in mmol / l

  7. Total Ca / Ionic Ca Ratio

    Time frame: 24 hours

    Relationship between the total calcium and the ionic one of the patient

  8. Match

    Time frame: 24 hours

    Value of this ion in the patient. It is measured in mmol / l.

  9. Magnesium

    Time frame: 24 hours

    Value of this ion in the patient. It is measured in mmol / l.

  10. Sodium

    Time frame: 24 hours

    Value of this ion in the patient. It is measured in mmol / l.

  11. Potassium

    Time frame: 24 hours

    Value of this ion in the patient. It is measured in mmol / l.

  12. Urea

    Time frame: 24 hours

    Urea level of the patient at the time of observation

  13. Creatinine

    Time frame: 24 hours

    Creatinine level of the patient at the time of observation

  14. INR

    Time frame: 24 hours

    INR level of the patient at the time of observation

  15. Lactate

    Time frame: 24 hours

    Lactate level of the patient at the time of observation

Sponsors and collaborators

Lead sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Other

Registry information

Official study title

Comparison of Diluted vs Concentrated Regional Citrate Anticoagulation in Continuous Renal Replacement Therapy: A Quasi-experimental Study

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 20, 2019
Registry last updated
Jan 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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