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

NCT04479878 | Completed

• 1 other identifier: ICM2013/40
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

parenteral nutrition

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Assessment of care practices

  from date of inclusion visit until an average of 1 year

• Assessment of care practices

  from date of inclusion visit until an average of 1 year

• Assessment of care practices

  from date of inclusion visit until an average of 1 year

• Evaluation of hospitalizations and central vein ablations

  from date of inclusion visit until an average of 1 year

• Evaluation of hospitalizations and central vein ablations

  from date of inclusion visit until an average of 1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patient With Cancer Receiving an Artificial Parenteral Nutrition in the Central Vein

You may qualify if:

• 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

You may not qualify if:

• 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);

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (1)

Icm Val D'Aurelle

Montpellier, Herault, 34298, France

Location

Related Publications (4)

• 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.

  PMID: 22633131 RESULT

• 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.

  PMID: 19489710 RESULT

• 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.

  PMID: 12415057 RESULT

• 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.

  PMID: 23137133 RESULT

MeSH Terms

Conditions

Neoplasms; Hyperphagia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Catherine Lacroix

  ICM Val d'Aurelle

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2020
• First Posted: July 21, 2020
• Study Start: November 1, 2013
• Primary Completion: May 31, 2015
• Study Completion: May 31, 2015
• Last Updated: July 21, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)