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

November 20, 2020 updated by: Hospital Universitari Vall d'Hebron Research Institute

Incidence of Complications of Peripheral Venous Access in the Type 2 Diabetic Population. Analysis of Risk Factors and Comparative Study of Two Peripheral Devices

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 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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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, 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

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Vall d'Hebron Research Institute-VHIR
        • Principal Investigator:
          • Marc Rivas, Nurse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients admitted to our hospital who require intravenous treatment and a peripheral venous device has been placed

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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 Names:
  • 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 Names:
  • Short canula, Midline, PICC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
How is the influence of T2DM on complications related to peripheral vascular catheters in hospitalized patients
Time Frame: 12 month
Rate of complications associated with catheters: thrombosis, infection, pain and skin reaction
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Investigators

  • Study Director: Rafael Simó, Prof., Vall Hebron Research Institute-VHIR

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2020

Primary Completion (ANTICIPATED)

January 30, 2021

Study Completion (ANTICIPATED)

May 15, 2021

Study Registration Dates

First Submitted

July 31, 2020

First Submitted That Met QC Criteria

July 31, 2020

First Posted (ACTUAL)

August 5, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 24, 2020

Last Update Submitted That Met QC Criteria

November 20, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR(AG)74/2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on Peripheral vascular catheters

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Paraguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe