Incidence of Complications of Peripheral Venous Access in the Type 2 Diabetic Population. Analysis of Risk Factors and Comparative Study of Two Peripheral Devices
| Registry | NCT04499638 |
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| Status | Completed |
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| Study type | Observational |
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| Enrollment | 350 (Actual) |
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| Sponsor | Hospital Universitari Vall d'Hebron Research Institute (Other) |
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| Conditions | Diabetes Mellitus, Type 2, Catheterization, Peripheral, Upper Extremity Deep Vein Thrombosis, Catheter-Related Infections, Diabetes Complications |
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| Interventions | Peripheral vascular catheters (Device) |
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| Dates | start 2020-01-01, primary completion 2021-01-30, completion 2021-05-15, first posted 2020-08-05, last updated 2025-02-25 |
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| Locations | 1 site in Spain |
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Related Papers Related Patents Related Grants Related Experts
All trials for Diabetes Mellitus, Type 2 All trials for Catheterization, Peripheral All trials of Peripheral vascular catheters
-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
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+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
+Arms and interventions
| Arm | Type | Interventions | Description |
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| Non type 2 diabetic patient | | 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 |
| Diabetic type 2 patient | | 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 |
- Peripheral vascular catheters (Device), also known as Short canula, Midline, PICC: Carry time of common peripheral vascular devices in clinical practice and the reason for his withdrawal
+Outcome measures
Primary outcomes
- How is the influence of T2DM on complications related to peripheral vascular catheters in hospitalized patients [12 month]: Rate of complications associated with catheters: thrombosis, infection, pain and skin reaction
+Eligibility
Sex: All, ages: 40 Years to 90 Years
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
+Locations (1)
| Facility | City | Country | Status |
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| Vall d'Hebron Research Institute-VHIR | Barcelona | Spain | |
+Publications
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+Investigators
- Rafael Simó, Prof., Study director, Vall Hebron Research Institute-VHIR