The Central Venous Catheter Related Complications in Critically Ill Patients

Sponsor

Zhujiang Hospital (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT03841240

Collaborator

(none)

500

Enrollment

Location

33.4

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Catheter Thrombosis Catheter-Related Infections Central Venous Catheter Related Bloodstream Infection Central Venous Catheter Thrombosis

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 19, 2019

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Outcome Measures

Primary Outcome Measures

The incidence of catheter-related complications [Average 10 days]
The incidence of catheter-related thrombosis and infections

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.