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

NCT04499638 | Completed

• 1 other identifier: PR(AG)74/2020
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

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

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)

Outcome Measures

Primary Outcomes (1)

• How is the influence of T2DM on complications related to peripheral vascular catheters in hospitalized patients

  Rate of complications associated with catheters: thrombosis, infection, pain and skin reaction

  12 month

Study Arms (2)

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

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

Interventions

Peripheral vascular catheters DEVICE

Carry time of common peripheral vascular devices in clinical practice and the reason for his withdrawal

Also known as: Short canula, Midline, PICC

Diabetic type 2 patient; Non type 2 diabetic patient

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Vall d'Hebron Research Institute-VHIR

Barcelona, 08035, Spain

Location

Related Publications (22)

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MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Upper Extremity Deep Vein Thrombosis; Catheter-Related Infections; Diabetes Complications

Interventions

Catheterization, Peripheral

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Infections

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Rafael Simó, Prof.

  Vall Hebron Research Institute-VHIR

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2020
• First Posted: August 5, 2020
• Study Start: January 1, 2020
• Primary Completion: January 30, 2021
• Study Completion: May 15, 2021
• Last Updated: February 25, 2025

Record last verified: 2025-02

Locations

ES (1)