Clinical trial NCT04479878: Complications in Adults With Cancer Receiving an Artificial Parenteral Nutrition in the Central Vein
Official title: Observational and Monocentric Study of Complications in Adults With Cancer Receiving an Artificial Parenteral Nutrition in the Central Vein Initiated in Hospitalization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: parenteral nutrition
Lead sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Sponsor class: OTHER
First posted: 2020-07-21
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patient With Cancer Receiving an Artificial Parenteral Nutrition in the Central Vein

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

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);

Primary outcomes:
measure: Prospective assessment of infectious and vascular complications in parenteral nutrition on implanted venous device through systematic registration in relation to care practices
timeFrame: from date of inclusion visit until an average of 1 year
measure: Prospective assessment of infectious and vascular complications in parenteral nutrition on implanted venous device through systematic registration in relation to care practices
timeFrame: from date of inclusion visit until an average of 1 year
Secondary outcomes:
measure: Assessment of care practices
timeFrame: from date of inclusion visit until an average of 1 year
measure: Assessment of care practices
timeFrame: from date of inclusion visit until an average of 1 year
measure: Assessment of care practices
timeFrame: from date of inclusion visit until an average of 1 year
measure: Evaluation of hospitalizations and central vein ablations
timeFrame: from date of inclusion visit until an average of 1 year
measure: Evaluation of hospitalizations and central vein ablations
timeFrame: from date of inclusion visit until an average of 1 year
measure: Evaluation of compliance with protocols for the medical care of infectious and vascular complications
timeFrame: from date of inclusion visit until an average of 1 year
measure: Evaluation of serious complications related to the central vein
timeFrame: from date of inclusion visit until an average of 1 year
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Icm Val D'Aurelle
state: Herault
Study officials:
affiliation: ICM Val d'Aurelle
name: Catherine Lacroix
role: STUDY_CHAIR
References:
citation: Toure A, Vanhems P, Lombard-Bohas C, Cassier P, Pere-Verge D, Souquet JC, Ecochard R, Chambrier C. Totally implantable central venous access port infections in patients with digestive cancer: incidence and risk factors. Am J Infect Control. 2012 Dec;40(10):935-9. doi: 10.1016/j.ajic.2012.01.024. Epub 2012 May 26.
citation: Mermel LA, Allon M, Bouza E, Craven DE, Flynn P, O'Grady NP, Raad II, Rijnders BJ, Sherertz RJ, Warren DK. Clinical practice guidelines for the diagnosis and management of intravascular catheter-related infection: 2009 Update by the Infectious Diseases Society of America. Clin Infect Dis. 2009 Jul 1;49(1):1-45. doi: 10.1086/599376.
citation: O'Grady NP, Alexander M, Dellinger EP, Gerberding JL, Heard SO, Maki DG, Masur H, McCormick RD, Mermel LA, Pearson ML, Raad II, Randolph A, Weinstein RA. Guidelines for the prevention of intravascular catheter-related infections. The Hospital Infection Control Practices Advisory Committee, Center for Disease Control and Prevention, U.S. Pediatrics. 2002 Nov;110(5):e51. doi: 10.1542/peds.110.5.e51.
citation: Ullmann AJ, Cornely OA, Donnelly JP, Akova M, Arendrup MC, Arikan-Akdagli S, Bassetti M, Bille J, Calandra T, Castagnola E, Garbino J, Groll AH, Herbrecht R, Hope WW, Jensen HE, Kullberg BJ, Lass-Florl C, Lortholary O, Meersseman W, Petrikkos G, Richardson MD, Roilides E, Verweij PE, Viscoli C, Cuenca-Estrella M; ESCMID Fungal Infection Study Group. ESCMID* guideline for the diagnosis and management of Candida diseases 2012: developing European guidelines in clinical microbiology and infectious diseases. Clin Microbiol Infect. 2012 Dec;18 Suppl 7:1-8. doi: 10.1111/1469-0691.12037.