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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04499638
• Other study ID #: PR(AG)74/2020
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: May 15, 2021

Study information

• Verified date: November 2020
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: Marc Rivas, Nurse
• Phone: 676083855
• Email: marc.rivas[@]vhir.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: May 15, 2021
• Est. primary completion date: January 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Catheter-Related Infections
• Catheterization, Peripheral
• Diabetes Complications
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Thrombosis
• Upper Extremity Deep Vein Thrombosis
• Venous Thrombosis

Intervention

Device:
• Peripheral vascular catheters
Carry time of common peripheral vascular devices in clinical practice and the reason for his withdrawal

Locations

Country	Name	City	State
Spain	Vall d'Hebron Research Institute-VHIR	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

References & Publications (22)

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Gao Y, Fan X, Han J. Prognostic factors for venous thrombosis in patients with peripherally inserted central catheters: Protocol for a systematic review and meta-analysis. Medicine (Baltimore). 2020 Jul 10;99(28):e21037. doi: 10.1097/MD.0000000000021037. — View Citation

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Low ZK, Ng WY, Fook-Chong S, Tan BK, Chong SJ, Hwee J, Tay SM. Comparison of clinical outcomes in diabetic and non-diabetic burns patients in a national burns referral center in Southeast Asia: A 3-year retrospective review; Methodological issues. Burns. 2017 Sep;43(6):1368. doi: 10.1016/j.burns.2017.03.019. Epub 2017 Jun 9. — View Citation

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* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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