Daily Ultrasound-screening for CVC-related Thrombosis (DUCT)

October 21, 2022 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

Daily Ultrasound-screening for CVC-related Thrombosis in Intensive Care Patients

The central venous catheters (CVC) related thrombosis is an issue of importance to ICU clinicians.This study conducts the daily ultrasound-screening for CVC-related thrombosis (DUCT).Its aim is to evaluate the characteristic and regularity of the central venous catheters (CVC) related thrombosis in ICU patients, and optimize the screening program of CVC-related thrombosis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1262

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hanzhou, Zhejiang, China, 310009
        • 2nd Affiliated Hospital, Zhejiang University School of Medicine Institute of Emergency Medicine, Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

We conduct an observational prospective multicenter study.The patients come from the ICUs of Zhejiang province.

Description

Inclusion Criteria:

  • Consecutive patients at least 18 years of age, expected to need a central venous catheterization for at least 48h in ICU.

Exclusion Criteria:

  • Patients with infection or inflammation or local trauma at the insertion site.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Characteristic and regularity of CRT
The patients who have a central venous catheterization conduct the daily ultrasound-screening for CVC-related Thrombosis (DUCT).
Device: ultrasound-screening
Daily ultrasound-screening for CVC-related thrombosis (DUCT) by compression ultrasound and color doppler ultrasound.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
the incidence rate of central venous catheters related thrombosis (CRT)
Time Frame: the assessment time will be from the time patients admitted in ICU to the time leaving ICU, less than 6 months.
the percentage of patients who have CRT in all patients included.
the assessment time will be from the time patients admitted in ICU to the time leaving ICU, less than 6 months.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
the time when the central venous catheters related thrombosis (CRT) occured
Time Frame: the assessment time will be from the time patients admitted in ICU to the time leaving ICU, less than 6 months.
which day the CRT is found after central venous catheter.
the assessment time will be from the time patients admitted in ICU to the time leaving ICU, less than 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Mao Zhang, MD, 2nd Affiliated Hospital, Zhejiang University School of Medicine Institute of Emergency Medicine, Zhejiang University
  • Principal Investigator: Weidong Tang, MD, The First People's Hospital of Fuyang District
  • Principal Investigator: Zhiping Huang, MD, Beilun District People's Hospital
  • Principal Investigator: Zhaohui Ji, MD, The First People's Hospital of Huzhou
  • Principal Investigator: Hong Liu, MD, Lishui Country People's Hospital
  • Principal Investigator: Lingcong Wang, MD, The First Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine
  • Principal Investigator: Mingwei Huang, MD, Jinhua Central Hospital
  • Principal Investigator: Xingwen Zhang, MD, Hunan People's Hospital
  • Principal Investigator: Yunchao Shi, MD, First Affiliated Hospital of Jiaxing University
  • Principal Investigator: Renfei Shan, MD, Taizhou Hospital
  • Principal Investigator: Fuzheng Tao, MD, Taizhou Hospital of integrated traditional Chinese and Western Medicine
  • Principal Investigator: Yi Wang, MD, First People's Hospital of Hangzhou
  • Principal Investigator: Qijiang Chen, MD, Ninghai First Hospital
  • Principal Investigator: Ning Zhang, MD, Lishui Country People's Hospital
  • Principal Investigator: Jian Hu, MD, Pinghu first people's Hospital
  • Principal Investigator: Dengpan Lai, MD, Affiliated Hospital of Hangzhou Teacher's University
  • Principal Investigator: Yingru Lu, MD, First Affiliated Hospital of Wenzhou Medical University
  • Principal Investigator: Xudong Zheng, MD, Ruian People's Hospital
  • Principal Investigator: Jianbo Gao, MD, The First People's Hospital of Fuyang District
  • Principal Investigator: Bei Tang, MD, Jiande First People's Hospital
  • Principal Investigator: Wansheng Li, MD, Taizhou Hospital
  • Principal Investigator: Xiaoyuan Shen, MD, Xiaoshan first people's Hospital
  • Principal Investigator: Yukang Song, MD, Wenling First People's Hospital
  • Principal Investigator: Guojuan Ding, MD, Shaoxing People's Hospital
  • Principal Investigator: Feng Wu, MD, Zhejiang Quhua Hospital
  • Principal Investigator: Xin Tian, MD, The Central Hospital of Lishui City
  • Principal Investigator: Shaoyi Xu, MD, The Second Affiliated Hospital of Jiaxing University
  • Principal Investigator: Weijun Fang, MD, The Central Hospital of Lishui City
  • Principal Investigator: LIfeng Wu, MD, Yuyao People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 8, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 31, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 24, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 21, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • z2jzk

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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