DUCT: Daily Ultrasound-screening for CVC-related Thrombosis
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03327376
Collaborator
(none)
500
1
46
10.9
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Daily Ultrasound-screening for CVC-related Thrombosis in Intensive Care Patients
Actual Study Start Date
:
Dec 1, 2017
Anticipated Primary Completion Date
:
Oct 1, 2021
Anticipated Study Completion Date
:
Oct 1, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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.
|
Outcome Measures
Primary Outcome Measures
- the incidence rate of central venous catheters related thrombosis (CRT) [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.
Secondary Outcome Measures
- the time when the central venous catheters related thrombosis (CRT) occured [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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 2nd Affiliated Hospital, Zhejiang University School of Medicine Institute of Emergency Medicine, Zhejiang University | Hanzhou | Zhejiang | China | 310009 |
Sponsors and Collaborators
- Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
- 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, First People's Hospital Affiliated to Huzhou University
- 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, Jiaxing First Hospital
- 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 Municipal 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
Study Documents (Full-Text)
None provided.More Information
Publications
- Faustino EV, Spinella PC, Li S, Pinto MG, Stoltz P, Tala J, Card ME, Northrup V, Baker KE, Goodman TR, Chen L, Silva CT. Incidence and acute complications of asymptomatic central venous catheter-related deep venous thrombosis in critically ill children. J Pediatr. 2013 Feb;162(2):387-91. doi: 10.1016/j.jpeds.2012.06.059. Epub 2012 Aug 9.
- Lee AY, Kamphuisen PW. Epidemiology and prevention of catheter-related thrombosis in patients with cancer. J Thromb Haemost. 2012 Aug;10(8):1491-9. doi: 10.1111/j.1538-7836.2012.04817.x. Review.
- Refaei M, Fernandes B, Brandwein J, Goodyear MD, Pokhrel A, Wu C. Incidence of catheter-related thrombosis in acute leukemia patients: a comparative, retrospective study of the safety of peripherally inserted vs. centrally inserted central venous catheters. Ann Hematol. 2016 Dec;95(12):2057-2064. Epub 2016 Aug 20.
Responsible Party:
Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier:
NCT03327376
Other Study ID Numbers:
- z2jzk
First Posted:
Oct 31, 2017
Last Update Posted:
Jul 16, 2021
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University
Additional relevant MeSH terms: