Complications in Adults With Cancer Receiving an Artificial Parenteral Nutrition in the Central Vein

Study Overview
=================
Brief Summary
-----------------
This observational study will evaluate the frequency of complications in adult cancer patients with central venous parenteral nutrition and the identification of aggravating factors.

Detailed Description
-----------------
In oncology, central venous catheters are used for treatments such as chemotherapy, hydration, antibiotic therapy and parenteral nutrition. However, these catheters are responsible for serious complications often infectious or vascular. They can lead to suspension or discontinuation of treatments and can lead to life-threatening outcomes for patients. The incidence rate and risk factors for central venous catheter-related infections in oncology remain poorly known. Recently, a prospective study targeted a 5-fold increase in the risk of catheter infection when parenteral nutrition was associated with chemotherapy. This is why the indications of parenteral nutrition must be respected and enteral nutrition promoted where possible. the investigator conducted a retrospective study in 1998 over 10 years and 6 months, including all patients who received or received a parenteral nutrition at home, for at least one month. Of 153 patients with implantable sites, 181 infectious episodes were recorded in 68 patients (44.4% of the population) with an estimated median infection rate of 2 infections/patients (1-12). There was a clear predominance of community-borne skin germs (85% Staphylococcus sp and 3% multi-resistant bacteria (BMR)). In order to improve our nursing practices, and reduce complications for patients,the investigator propose the establishment of an observatory of complications in adults with cancer benefiting from superior parenteral nutrition on the central venous tract initiated in hospitalization with a planned return home

Official Title
-----------------
Observational and Monocentric Study of Complications in Adults With Cancer Receiving an Artificial Parenteral Nutrition in the Central Vein Initiated in Hospitalization

Conditions
-----------------
Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Central venous parenteral nutrition initiated in hospitalization with a planned return home (with parenteral nutrition). Life expectancy > 3 months OMS (World Health Organization) performance status (PS) 0, 1 or 2 With initial dietary consultation during hospitalization Age ≥ 18 years Hospitalized 48 hours or more Patient Information and Signature of Informed Consent patient must be affiliated to a French Social Security System Exclusion Criteria: OMS> 3 or 4 Patient in the process of infection Patient followed up in surgery Patient without central vein Patient with superior cave thrombosis, Inability to undergo medical follow-up of the trial for geographical, social or psychological reasons, Terminally ill palliative patient, excluding surgery. Patient whose regular follow-up is not possible due to psychological, family, social or geographical reasons; • Medical or psychological condition which, in the opinion of the investigator, will not allow the patient to complete the study or sign informed consent with full knowledge (Article L.1121-6, L.1121-7, L. 1211-8, L. 1211-9);

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prospective assessment of infectious and vascular complications in parenteral nutrition on implanted venous device through systematic registration in relation to care practices | Number and date of infectious complications per patient | from date of inclusion visit until an average of 1 year | 
| Prospective assessment of infectious and vascular complications in parenteral nutrition on implanted venous device through systematic registration in relation to care practices | Number and date of vascular complications per patient | from date of inclusion visit until an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of care practices | Assessment of Nurse's Handwashing Every Two Weeks (10-point note) | from date of inclusion visit until an average of 1 year | 
| Assessment of care practices | Evaluation of the consumption of sterile sets (for connections and disconnections on the Central Venous Way) and Huber needles by the provider every two weeks (note on 10 points) | from date of inclusion visit until an average of 1 year | 
| Assessment of care practices | Evaluation of pulsed rinse after nutrition by the nursing office - question asked only once at the end of observation (never - sometimes to often - always) | from date of inclusion visit until an average of 1 year | 
| Evaluation of hospitalizations and central vein ablations | Collection of the number of hospitalizations | from date of inclusion visit until an average of 1 year | 
| Evaluation of hospitalizations and central vein ablations | Collection of the duration of hospitalizations | from date of inclusion visit until an average of 1 year | 
| Evaluation of compliance with protocols for the medical care of infectious and vascular complications | assessment of adherence to protocols for the management of infectious and vascular complications on a 5-point scale corresponding to the 5 main recommended international steps for infectious complications, and on 1 point (yes/no) according to the parenteral nutrition treaty for vascular complications | from date of inclusion visit until an average of 1 year | 
| Evaluation of serious complications related to the central vein | number of complications related to the central vein per patient | from date of inclusion visit until an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
parenteral nutrition