Clinical trial NCT04499638: Incidence of Complications of Peripheral Venous Access in the Type 2 Diabetic Population
Official title: Incidence of Complications of Peripheral Venous Access in the Type 2 Diabetic Population. Analysis of Risk Factors and Comparative Study of Two Peripheral Devices
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Catheterization, Peripheral
Upper Extremity Deep Vein Thrombosis
Catheter-Related Infections
Diabetes Complications
Keywords: Diabetes Mellitus Type 2
Catheter-Related complications
Short peripheral venous catheter
Medium line peripheral catheter (Midline)
Peripheral Insertion Central Catheter (PICC)
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2020-08-05
Enrollment: 350
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to our hospital who require intravenous treatment and a peripheral venous device has been placed

Brief summary: 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

Detailed description: 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:

* T2DM is an independent risk factor for catheter-related complications.
* The use of new vascular access devices (Midline, PICC) in patients with T2DM would be associated with a lower risk of catheter-related complications.

Main objective:

- To assess the influence of T2DM on complications related to peripheral vascular catheters in hospitalized patients.

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

Eligibility criteria: Inclusion Criteria:

* Peripheral venous access requirement \>7 days
* Administration of intravenous treatment

Exclusion Criteria:

* Peripheral venous access for urgent or life-threatening pathology
* Acute psychiatric pathology
* Impossibility of peripheral venous access through the upper limb (amputations, extensive burns, etc.)
* History of venous thrombosis due to catheter less than 1 year

Primary outcomes:
measure: How is the influence of T2DM on complications related to peripheral vascular catheters in hospitalized patients
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Vall d'Hebron Research Institute-VHIR
Study officials:
affiliation: Vall Hebron Research Institute-VHIR
name: Rafael Simó, Prof.
role: STUDY_DIRECTOR
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