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

NCT ID: NCT04479878

Last Updated: 2020-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-01

Study Completion Date

2015-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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);
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Institut du Cancer de Montpellier - Val d'Aurelle

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Catherine Lacroix

Role: STUDY_CHAIR

ICM Val d'Aurelle

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Icm Val D'Aurelle

Montpellier, Herault, France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 22633131 (View on PubMed)

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.

Reference Type RESULT
PMID: 19489710 (View on PubMed)

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.

Reference Type RESULT
PMID: 12415057 (View on PubMed)

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.

Reference Type RESULT
PMID: 23137133 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ICM2013/40

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Management of Malnutrition in Oncogeriatrics
NCT06425315 NOT_YET_RECRUITING