The Central Venous Catheter Related Complications in Critically Ill Patients

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

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.

Study Overview

• Status: Unknown
• Conditions: Central Venous Catheter Thrombosis; Catheter-Related Infections; Catheter Thrombosis; Central Venous Catheter Related Bloodstream Infection

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 Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510282
      • Department of Critical Care Medicine of Zhujiang Hospital,Southern Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population comes from the five critical medical wards of Zhujiang Hospital , including integrated area, cardiovascular severe ward, respiratory severe ward, neurological severe ward and neurosurgical severe ward.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of catheter-related complications	The incidence of catheter-related thrombosis and infections	Average 10 days

Collaborators and Investigators

• Sponsor: Zhujiang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2019
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: January 29, 2019
• First Submitted That Met QC Criteria: February 12, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): August 10, 2021
• Last Update Submitted That Met QC Criteria: August 9, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: ultrasound; infection; thrombosis; risk factor; catheter
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Disease Attributes; Embolism and Thrombosis; Venous Thrombosis; Sepsis; Infections; Communicable Diseases; Thrombosis; Upper Extremity Deep Vein Thrombosis; Catheter-Related Infections
• Other Study ID Numbers: 2018ZZJHZX003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No