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

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: Completed
• Conditions: Critical Illness; Ultrasonography; Central Venous Catheter Thrombosis
• Intervention / Treatment: Device: ultrasound-screening

• Study Type: Observational
• Enrollment (Actual): 1262

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the incidence rate of central venous catheters related thrombosis (CRT)	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

Outcome Measure	Measure Description	Time Frame
the time when the central venous catheters related thrombosis (CRT) occured	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

• Sponsor: 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, 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

General 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.
• 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. doi: 10.1007/s00277-016-2798-4. Epub 2016 Aug 20.
• Parienti JJ, Mongardon N, Megarbane B, Mira JP, Kalfon P, Gros A, Marque S, Thuong M, Pottier V, Ramakers M, Savary B, Seguin A, Valette X, Terzi N, Sauneuf B, Cattoir V, Mermel LA, du Cheyron D; 3SITES Study Group. Intravascular Complications of Central Venous Catheterization by Insertion Site. N Engl J Med. 2015 Sep 24;373(13):1220-9. doi: 10.1056/NEJMoa1500964.
• Gentile A, Petit L, Masson F, Cottenceau V, Bertrand-Barat J, Freyburger G, Pinaquy C, Leger A, Cochard JF, Sztark F. Subclavian central venous catheter-related thrombosis in trauma patients: incidence, risk factors and influence of polyurethane type. Crit Care. 2013 May 29;17(3):R103. doi: 10.1186/cc12748.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): January 1, 2022
• Study Completion (Actual): January 1, 2022

Study Registration Dates

• First Submitted: October 8, 2017
• First Submitted That Met QC Criteria: October 26, 2017
• First Posted (Actual): October 31, 2017

Study Record Updates

• Last Update Posted (Actual): October 24, 2022
• Last Update Submitted That Met QC Criteria: October 21, 2022
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: critical care; ultrasound; venous thrombosis; central venous catheters
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Disease Attributes; Embolism and Thrombosis; Venous Thrombosis; Critical Illness; Thrombosis; Upper Extremity Deep Vein Thrombosis
• Other Study ID 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