The Central Venous Catheter Related Complications in Critically Ill Patients

Catheter-Related Infections Clinical Trial

Official title:

The Central Venous Catheter Related Complications in Critically Ill Patients: A Prospective Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03841240
• Other study ID #: 2018ZZJHZX003
• Status: Enrolling by invitation
• Start date: February 19, 2019
• Est. completion date: December 2021

Study information

• Verified date: January 2021
• Source: Zhujiang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In this prospective clinical study, the researchers investigate the incidence of catheter-related thrombosis and catheter-related infection during indwelling central venous catheterization in critically ill patients, and analyzed the risk factors for catheter-related complications and the relationship between catheter-related thrombi and catheter-related infections. The sample size is about 500.

Description:

A prospective clinical trial is conducted. Five hundred participants who need to place central venous catheters admit to the Department of Critical Care Medicine of Zhujiang Hospital,Southern Medical University from February 2019. Ultrasound is used for screening catheter-related thrombosis, and catheter-related infections are diagnosed according to the Guidelines for the Diagnosis and Management of Intravascular Catheter-Related Infections. The primary outcome is the incidence of catheter-related thrombosis and catheter-related infections. The primary exposure factors are age, gender, APACHE II, RBC, Hct, PLT, FIB, D-dimer, PCT, blood glucose, anticoagulants, and vasoactive drugs, catheter type, tube placement, indwelling time, etc. Descriptive analysis is used for the incidence of various complications. T-test or non-parametric statistical test is used for single factor analysis of risk factors, chi-square test or Fisher's exact probability test is used for counting data. Multivariate analysis of risk factors and the relationship between complications are analyzed by logistic regression. Statistical analysis is performed with SPSS Statistics version 20.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 500
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age > 18 years old and <80 years old;
• Central venous catheter is required to be placed through the internal jugular vein, subclavian vein or femoral vein;
• Catheter placement is estimated to be = 72 hours.

Exclusion Criteria:

• The central venous catheter has been placed before entering the department;
• There is obvious trauma or infection at the site of implantation;
• There is already a blood vessel thrombus in the site before implantation;
• Recently, deep vein thrombosis or catheter-related thrombosis has occurred.

Related Conditions & MeSH terms

• Catheter Thrombosis
• Catheter-Related Infections
• Central Venous Catheter Related Bloodstream Infection
• Central Venous Catheter Thrombosis
• Communicable Diseases
• Infection
• Sepsis
• Thrombosis
• Upper Extremity Deep Vein Thrombosis

Locations

Country	Name	City	State
China	Department of Critical Care Medicine of Zhujiang Hospital,Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhujiang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of catheter-related complications	The incidence of catheter-related thrombosis and infections	Average 10 days