Section: INVESTIGATING TO CARE...
Alfredo Serrano Ruiz. Unidad de Cuidados Intensivos Quirúrgicos. Hospital Universitario Puerta de Hierro Majadahonda. C/ Joaquín Rodrigo, 2. 28222 Maj
Contact email: aserrano.hpth@salud,madrid.org
Objective: to assess the efficacy of a sealing solution at 0,9% as compared a heparin solution 250 U/ml for maintenance of permeability of the lumen of non-permanent central venous catheters.
Methods: a controlled, prospective, double blind clinical trial, with randomisation into two groups and stratified by centre. Subjects: patients admitted to the ICU who are inserted a non-permanent three-lumen central venous catheter, being one lumen exclusively used for the intermittent administration of the drug, as per doctors orders. One single catheter will be included per patient
Scope: Madrid hospitals (Puerta de Hierro, Móstoles, Getafe) and the Ciudad Real hospital. Intervention: standardisation of the cleaning and rinsing process, administration of the drugs, subsequent cleaning and sealing of the lumen with saline solution for one group and heparin solution 250 U/ml for the other trial group. Standardisation of catheter care. Primary endpoint: obstruction (impossibility to administer via syringe 10 ml saline solution at 0.9%) of the free lumen in the catheter. Analysis: analyses will be carried out as per the assigned treatment method (intention to treat - ITT) and as per protocol. Comparison of the obstruction rates between both groups will be performed by multiple logistic regression analysis, where the outcome variable will be the presence or absence of obstruction and the treatment group and centre where the trial is conducted will be the independent variables.
Applicability: the generation of new scientific clinical evidence in this sense, will permit further insight and the attainment of solid argumentation for the elaboration of clinical practice guidelines on the permeability of central venous catheters.
nursing; intensive care; central venous catheter; permeability; clinical trial; project
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