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Incidence of Complications of Peripheral Venous Access in the Type 2 Diabetic Population

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ClinicalTrials.gov Identifier: NCT04499638
Recruitment Status : Recruiting
First Posted : August 5, 2020
Last Update Posted : August 5, 2020
Sponsor:
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute

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, a observational case-control study has been proposed in order to analyze the impact of T2DM disease and its associated complications on the patient requiring peripheral venous access. Furthermore we 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


Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 Catheterization, Peripheral Upper Extremity Deep Vein Thrombosis Catheter-Related Infections Diabetes Complications Device: Peripheral vascular catheters

Detailed Description:

This Prospective case-control study will be carry 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 analyzed. 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, our 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 in our center, the sample proposed is totally acceptable

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
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
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : January 30, 2021
Estimated Study Completion Date : May 15, 2021

Group/Cohort Intervention/treatment
Non type 2 diabetic patient
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
Other Name: Short canula, Midline, PICC

Diabetic type 2 patient
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
Other Name: Short canula, Midline, PICC




Primary Outcome Measures :
  1. To assess the influence of T2DM on complications related to peripheral vascular catheters in hospitalized patients [ Time Frame: 12 month ]
    Observation of complications associated with catheters: thrombosis, infection, pain and skin reaction



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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted to our hospital who require intravenous treatment and a peripheral venous device has been placed
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 lower limb (amputations, extensive burns, etc.)
  • History of venous thrombosis due to catheter less than 1 year

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04499638


Contacts
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Contact: Marc Rivas, Nurse 676083855 marc.rivas@vhir.org
Contact: Andrea Ciudin, Prof. 697817352 aciudin@vhebron.net

Locations
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Spain
Vall d'Hebron Research Institute-VHIR Recruiting
Barcelona, Spain, 08035
Principal Investigator: Marc Rivas, Nurse         
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
Investigators
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Study Director: Rafael Simó, Prof. Vall Hebron Research Institute-VHIR
Publications:

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Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT04499638    
Other Study ID Numbers: PR(AG)74/2020
First Posted: August 5, 2020    Key Record Dates
Last Update Posted: August 5, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
Diabetes Mellitus Type 2
Catheter-Related complications
Short peripheral venous catheter
Medium line peripheral catheter (Midline)
Peripheral Insertion Central Catheter (PICC)
Additional relevant MeSH terms:
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Catheter-Related Infections
Thrombosis
Venous Thrombosis
Upper Extremity Deep Vein Thrombosis
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Complications
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Infection