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

NCT03157245 | Unknown

• 1 other identifier: 2017-A00043-50
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Critically Ill; Central Venous Catheter Thrombosis; PARENTERAL NUTRITION; POST OPERATIVE

Outcome Measures

Primary Outcomes (1)

• Presence or no of a catheter related thrombosis

  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.

  1 day (day of the catheter removal)

Secondary Outcomes (1)

• clinical factors associated with the presence of catheter related thrombosis

  post operative period, during the intensive care unit stay

Study Arms (1)

participant

Diagnostic Test: DOPPLER ULTRASOUND

Interventions

DOPPLER ULTRASOUND DIAGNOSTIC_TEST

MESURE OF THE PRESENCE OR NOT OF A CATHETER RELATED VEIN THROMBOSIS

participant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient \> 18 years old, admitted in surgical critical care, immediatly after elective carcinologic surgery with a central venous catheter for parenteral nutrition

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

NOVY

Vandœuvre-lès-Nancy, 54500, France

RECRUITING

MeSH Terms

Conditions

Critical Illness; Upper Extremity Deep Vein Thrombosis; Hyperphagia

Interventions

Ultrasonography, Doppler

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms, Digestive; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: May 17, 2017
• Study Start: June 2, 2017
• Primary Completion: May 31, 2018
• Study Completion: May 31, 2019
• Last Updated: June 8, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)