Catheter ThrombosisNCT03841240
The Central Venous Catheter Related Complications in Critically Ill Patients
An observational study of Catheter Thrombosis and Catheter-Related Infections, run by Zhujiang Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Catheter Thrombosis, Catheter-Related Infections, Central Venous Catheter Related Bloodstream Infection
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 19 Feb 2019to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Critical Care Medicine of Zhujiang Hospital,Southern Medical University
Guangzhou, Guangdong, 510282
About this study
Official title: 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.
Read the 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.
- Conditions
- Catheter Thrombosis, Catheter-Related Infections, Central Venous Catheter Related Bloodstream Infection, Central Venous Catheter Thrombosis
- Keywords
- catheter, thrombosis, infection, ultrasound, risk factor
- Medical subject headings
- Catheter-Related Infections, Upper Extremity Deep Vein Thrombosis, Thrombosis, Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of catheter-related complications
The incidence of catheter-related thrombosis and infections
Measured: Average 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start19 Feb 2019
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter ThrombosisStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03841240
- Sponsor's protocol ID
- 2018ZZJHZX003
- Status last verified
- Jan 2021
- First submitted
- 29 Jan 2019
- Last updated
- 10 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Central Venous Catheter Related Complications in Critically Ill Patients: A Prospective Study
- ClinicalTrials.gov ID
- NCT03841240
- Acronym / sponsor ID
- 2018ZZJHZX003
- Conditions
- Catheter Thrombosis, Catheter-Related Infections, Central Venous Catheter Related Bloodstream Infection, Central Venous Catheter Thrombosis
- Keywords
- catheter, thrombosis, infection, ultrasound, risk factor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 19 Feb 2019 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The incidence of catheter-related complications
Time frame: Average 10 days
The incidence of catheter-related thrombosis and infections
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Catheter Thrombosis and Catheter-Related Infections, run by Zhujiang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of catheter-related complications (time frame: Average 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2021.