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

Completed

• Conditions: Cancer

• Registration Number: NCT04479878
• Lead Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

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

Study Timeline

• Study Start: 2013-11-01
• Primary Completion: 2015-05-31
• Study Completion: 2015-05-31
• Status Verified: 2020-07
• Study First Submitted: 2020-07-06
• Study First Submitted QC: 2020-07-20
• Last Update Submitted: 2020-07-20
• Study First Posted: 2020-07-21
• Last Update Posted: 2020-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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);

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Evaluation of serious complications related to the central vein	from date of inclusion visit until an average of 1 year	number of complications related to the central vein per patient
Evaluation of compliance with protocols for the medical care of infectious and vascular complications	from date of inclusion visit until an average of 1 year	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
Assessment of care practices	from date of inclusion visit until an average of 1 year	Evaluation of pulsed rinse after nutrition by the nursing office - question asked only once at the end of observation ("never" - "sometimes to often" - "always")
Evaluation of hospitalizations and central vein ablations	from date of inclusion visit until an average of 1 year	Collection of the duration of hospitalizations

Trial Locations

Locations (1)

Icm Val D'Aurelle; 🇫🇷 Montpellier, Herault, France