Clinical Trials Directory

Trials / Completed

CompletedNCT04062812

New Protocol With Diluted Citrate in Continuous Techniques

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
66 (actual)
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
OTHERthe same citrate dosification in both typesmatch concentrated and dilute citrate protocol

Timeline

Start date
2019-08-01
Primary completion
2021-10-01
Completion
2021-12-20
First posted
2019-08-20
Last updated
2024-01-12

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT04062812. Inclusion in this directory is not an endorsement.