An observational study in Diabetes Mellitus, Type 2, Catheterization, Peripheral and Upper Extremity Deep Vein Thrombosis, sponsored by Hospital Universitari Vall d'Hebron Research Institute. Completed at 1 site in Spain. Open to participants aged 40 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-02-25.
Sponsored by Hospital Universitari Vall d'Hebron Research Institute · Observational
Diabetes Mellitus type 2 (T2DM) is one of the most frequent metabolic diseases worldwide. It is expected that in 2035 around 600 million people will suffer from the disease. A recent systematic review has estimated that the direct annual cost of Diabetes worldwide treatments and care is over $ 827 billion and has been independently associated with nosocomial complications, thrombosis-like infections and prolonged admissions. In addition, it is estimated that up to 90% of patients in acute hospitals require a peripheral venous catheter which are associated at the same time with mechanical, infectious and thrombotic acute complications. Recently the emergence of new medium-sized peripheral devices (Midline®) and new peripheral central venous access catheters (PICC), which are more biocompatible, are opening new clinical possibilities with the aim of improving safety and comfort during treatment time and the reduction of associated complications.
With all this, an observational case-control study has been proposed in order to analyse the impact of T2DM disease and its associated complications on the patient requiring peripheral venous access. Furthermore investigators will consider if these new peripheral devices can be a remarkable benefit for these patients. This study will be carried out at the Vall d'Hebron University Hospital in Barcelona, Spain
This Prospective case-control study will be carried out with patients that will be admitted in the hospitalization areas of the Vall d'Hebron Hospital. All research data will be collected by the hospital's vascular access nursing team. Complications related to peripheral venous access (phlebitis, thrombosis, pain, erythema, extravasation) and the time of catheter replacement are the focus outcomes of the present study and possible differences between the control group and the sample population of the T2DM will be analysed. General clinical and anthropometric data (age, sex, BMI, toxic habits,...), cause of admission, co-morbidities, and all variables related to diabetes (time of evolution, degree of glycemic control, treatment, and presence of chronic complications) will also be collected. If there are any significant differences, they will be related to the different risk factors associated with T2DM through association of different epidemiological variables. Furthermore in this hypothetical case, the research team would intend to develop and carry out molecular studies through analysis of blood and urine components, proteinomics and genetic studies.
Hypothesis:
Main objective:
It is expected to colect information of N=500 samples, 250 control group (noT2DM subjects) and 250 study group (T2DM subjects). Due to previous experience, the sample proposed is totally acceptable
107 studies on the registry are indexed under Catheter-Related Infections; 16 are open to participants now.
This study's enrollment of 350 is above the median of 200 across 25 observational studies indexed under Catheter-Related Infections.
Browse Catheter-Related Infections studies →Hospital Universitari Vall d'Hebron Research Institute is the lead sponsor of 268 studies on the registry; 61 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients admitted to our hospital who require intravenous treatment and a peripheral venous device has been placed
Exclusion Criteria:
Tracking the catheter from insertion to removal. Collection of any patients complication associated with these devices and what different treatments has been administered
Device: Peripheral vascular catheters
Tracking the catheter from insertion to removal.Collection of any patients complication associated with these devices and what different treatments has been administered
Device: Peripheral vascular catheters
Carry time of common peripheral vascular devices in clinical practice and the reason for his withdrawal
Also known as: Short canula, Midline, PICC
How is the influence of T2DM on complications related to peripheral vascular catheters in hospitalized patients
Rate of complications associated with catheters: thrombosis, infection, pain and skin reaction
Time frame: 12 month
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Hospital Universitari Vall d'Hebron Research Institute