Daily Ultrasound-screening for CVC-related Thrombosis

Critical Illness Clinical Trial

— DUCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03327376
• Other study ID #: z2jzk
• Status: Completed
• Start date: December 1, 2017
• Est. completion date: January 1, 2022

Study information

• Verified date: October 2017
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1262
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Central Venous Catheter Thrombosis
• Critical Illness
• Thrombosis
• Ultrasonography
• Upper Extremity Deep Vein Thrombosis

Intervention

Device:
• ultrasound-screening
Daily ultrasound-screening for CVC-related thrombosis (DUCT) by compression ultrasound and color doppler ultrasound.

Locations

Country	Name	City	State
China	2nd Affiliated Hospital, Zhejiang University School of Medicine Institute of Emergency Medicine, Zhejiang University	Hanzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View Citation

Gentile A, Petit L, Masson F, Cottenceau V, Bertrand-Barat J, Freyburger G, Pinaquy C, Léger A, Cochard JF, Sztark F. Subclavian central venous catheter-related thrombosis in trauma patients: incidence, risk factors and influence of polyurethane type. Cri — View Citation

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. — View Citation

Parienti JJ, Mongardon N, Mégarbane B, Mira JP, Kalfon P, Gros A, Marqué 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 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.