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Completed

NCT Number: NCT04479878

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Icm Val D'Aurelle

Montpellier, Herault, 34298, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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);

Treatment and study plan

Primary outcomes

  1. 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

    Number and date of infectious complications per patient

  2. 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

    Number and date of vascular complications per patient

Secondary outcomes

  1. Assessment of care practices

    Time frame: from date of inclusion visit until an average of 1 year

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

  2. Assessment of care practices

    Time frame: from date of inclusion visit until an average of 1 year

    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)

  3. Assessment of care practices

    Time frame: from date of inclusion visit until an average of 1 year

    Evaluation of pulsed rinse after nutrition by the nursing office - question asked only once at the end of observation ("never" - "sometimes to often" - "always")

  4. Evaluation of hospitalizations and central vein ablations

    Time frame: from date of inclusion visit until an average of 1 year

    Collection of the number of hospitalizations

  5. Evaluation of hospitalizations and central vein ablations

    Time frame: from date of inclusion visit until an average of 1 year

    Collection of the duration of hospitalizations

  6. Evaluation of compliance with protocols for the medical care of infectious and vascular complications

    Time frame: from date of inclusion visit until an average of 1 year

    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

  7. Evaluation of serious complications related to the central vein

    Time frame: from date of inclusion visit until an average of 1 year

    number of complications related to the central vein per patient

Sponsors and collaborators

Lead sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Other

Registry information

Official study title

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

Acronym: ONAC

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 21, 2020
Registry last updated
Jul 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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