Incidence of Deep Vein Thrombosis on Central Venous Catheters in the Post Operative Period of Carcinologic Surgery

• Conditions: Central Venous Catheter Thrombosis; Critically Ill; PARENTERAL NUTRITION; POST OPERATIVE
• Interventions: Diagnostic Test: DOPPLER ULTRASOUND

• Registration Number: NCT03157245
• Lead Sponsor: Central Hospital, Nancy, France

Brief Summary

The objective is to determine the incidence of thrombosis on central venous catheters in patients hospitalized in a surgical critical care unit, in the immediate postoperative period of urological or digestive carcinological surgery, and receiving parenteral nutrition.

Detailed Description

The post operative period, wich is a critically ill condition, and history of cancer are related to a high risk of venous thrombosis. Catheter is one of the most common complication of parenteral nutrition and is also related to thrombosis.

The combination of theses conditions increases the risk of venous catheter thrombosis. , Since, there is no data evaluating this risk nowadays, the objective of this study is to determine the incidence of thrombosis on central venous catheters in patients hospitalized in a surgical critical care unit, in the immediate postoperative period of urological or digestive carcinological surgery, and receiving parenteral nutrition.

Study Timeline

• Status Verified: 2017-05
• Study First Submitted: 2017-05-15
• Study First Submitted QC: 2017-05-16
• Study First Posted: 2017-05-17
• Study Start: 2017-06-02
• Last Update Submitted: 2017-06-07
• Last Update Posted: 2017-06-08
• Primary Completion: 2018-05-31
• Study Completion: 2019-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Hospitalization in surgical intensive care in the immediate post-operative period
• surgery for cancer
• central venous catheter placement for parenteral nutrition
• written consent dated and signed before doppler examination

Exclusion Criteria

• patient < 18 years old
• pregnancy
• surgery with no indication for parenteral nutrition on central venous access

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
participant	DOPPLER ULTRASOUND	-

Primary Outcome Measures

Name	Time	Method
Presence or no of a catheter related thrombosis	1 day (day of the catheter removal)	Patients will undergo an examination by a specialist in vascular medicine just before removal of the catheter.This specialist also is specialist in vascular doppler ultrasonography.; The specialist would search symptoms and signs of deep vein thrombosis : local pain, swelling, redness, warmth. Clinical examinated would be completed by doppler ultrasound : thrombus is detected during a compression test, while cruor is evaluated in B-mode (gray-scale) imaging. This method is very sensitive with regard to detection of the thrombus.

Secondary Outcome Measures

Name	Time	Method
clinical factors associated with the presence of catheter related thrombosis	post operative period, during the intensive care unit stay	During the intensive care unit stay, the investigator would prospectively collected data, including : * potential risk factors : age, history of venous thrombosis, type of cancer...; * details of surgery : type and operating time; * details of critically ill period : number and type of organs failures, first mobilisation..; * details of the clinical course : occurence of a situation requiring curative anticoagulation..

Trial Locations

Locations (1)

NOVY; 🇫🇷 Vandoeuvre les Nancy, France