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

Cancer Clinical Trial

— ONAC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04479878
• Other study ID #: ICM2013/40
• Status: Completed
• Start date: November 1, 2013
• Est. completion date: May 31, 2015

Study information

• Verified date: July 2020
• Source: Institut du Cancer de Montpellier - Val d'Aurelle
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 31, 2015
• Est. primary completion date: May 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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);

Related Conditions & MeSH terms

• Cancer

Locations

Country	Name	City	State
France	Icm Val D'Aurelle	Montpellier	Herault

Sponsors (1)

Lead Sponsor	Collaborator
Institut du Cancer de Montpellier - Val d'Aurelle

Country where clinical trial is conducted

France, 

References & Publications (4)

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 So — View 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 Co — View Citation

Touré A, Vanhems P, Lombard-Bohas C, Cassier P, Péré-Vergé 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 — View 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-Flörl C, Lortholary O, Meersseman W, Petrikkos G, Richardso — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Evaluation of hospitalizations and central vein ablations	Collection of the number of hospitalizations	from date of inclusion visit until an average of 1 year
Secondary	Evaluation of hospitalizations and central vein ablations	Collection of the duration of hospitalizations	from date of inclusion visit until an average of 1 year
Secondary	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
Secondary	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