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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

Tracking Information
First Submitted Date July 31, 2020
First Posted Date August 5, 2020
Last Update Posted Date August 5, 2020
Actual Study Start Date January 1, 2020
Estimated Primary Completion Date January 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 31, 2020)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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

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

Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration 1 Year
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients admitted to our hospital who require intravenous treatment and a peripheral venous device has been placed
Condition
  • Diabetes Mellitus, Type 2
  • Catheterization, Peripheral
  • Upper Extremity Deep Vein Thrombosis
  • Catheter-Related Infections
  • Diabetes Complications
Intervention 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
Study Groups/Cohorts
  • 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
    Intervention: Device: Peripheral vascular catheters
  • 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
    Intervention: Device: Peripheral vascular catheters
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 31, 2020)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 15, 2021
Estimated Primary Completion Date January 30, 2021   (Final data collection date for primary outcome measure)
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 lower limb (amputations, extensive burns, etc.)
  • History of venous thrombosis due to catheter less than 1 year
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Marc Rivas, Nurse 676083855 marc.rivas@vhir.org
Contact: Andrea Ciudin, Prof. 697817352 aciudin@vhebron.net
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT04499638
Other Study ID Numbers PR(AG)74/2020
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Hospital Universitari Vall d'Hebron Research Institute
Study Sponsor Hospital Universitari Vall d'Hebron Research Institute
Collaborators Not Provided
Investigators
Study Director: Rafael Simó, Prof. Vall Hebron Research Institute-VHIR
PRS Account Hospital Universitari Vall d'Hebron Research Institute
Verification Date July 2020