New Protocol With Diluted Citrate in Continuous Techniques

Status Completed

Clinical 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. 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.

Clinical Trial Description

Study design: quasi-experimental design. two groups: 1. Usual protocol with Multifiltrate monitor and citrate (136 mmol/l) 2. 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04062812
Study type	Interventional
Source	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Contact
Status	Completed
Phase	N/A
Start date	August 1, 2019
Completion date	December 20, 2021

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.