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CancerONACNCT04479878

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

An observational study of Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
How many people
25 participants
Where
1 siteFrance
Study dates
1 Nov 2013to 31 May 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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);

Trial locations and contacts

1 site in 1 country.

France1 site

  • Icm Val D'Aurelle

    Montpellier, Herault, 34298

Other trials in France

About this study

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

This observational study will evaluate the frequency of complications in adult cancer patients with central venous parenteral nutrition and the identification of aggravating factors.

Read the 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

Conditions
Cancer
Keywords
parenteral nutrition
Medical subject headings
Neoplasms, Hyperphagia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: from date of inclusion visit until an average of 1 year

  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 vascular complications per patient

    Measured: from date of inclusion visit until an average of 1 year

Secondary outcomes (7)

  1. Assessment of care practices

    Assessment of Nurse's Handwashing Every Two Weeks (10-point note)

    Measured: from date of inclusion visit until an average of 1 year

  2. 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)

    Measured: from date of inclusion visit until an average of 1 year

  3. 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")

    Measured: from date of inclusion visit until an average of 1 year

  4. Evaluation of hospitalizations and central vein ablations

    Collection of the number of hospitalizations

    Measured: from date of inclusion visit until an average of 1 year

  5. Evaluation of hospitalizations and central vein ablations

    Collection of the duration of hospitalizations

    Measured: from date of inclusion visit until an average of 1 year

  6. 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

    Measured: from date of inclusion visit until an average of 1 year

  7. Evaluation of serious complications related to the central vein

    number of complications related to the central vein per patient

    Measured: from date of inclusion visit until an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2020
  2. Study start1 Nov 2013
  3. Primary completion31 May 2015
  4. Study completion31 May 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04479878
Sponsor's protocol ID
ICM2013/40
Acronym
ONAC
Status last verified
Jul 2020
First submitted
6 Jul 2020
Last updated
21 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 22633131

  • 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.

    PubMed 19489710

  • 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.

    PubMed 12415057

  • 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.

    PubMed 23137133

Questions about this trial

What is this clinical trial studying?

An observational study of Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prospective assessment of infectious and vascular complications in parenteral nutrition on implanted venous device through systematic registration in relation to care practices (time frame: from date of inclusion visit until an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04479878, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2020.

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