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A Monocenter Prospective Study to Evaluate the Efficacy of Peripherally Inserted Central Catheter to Tunnelled Central Catheter With Cuff in Home Parenteral Nutrition for Long-term Used. (PICCNUT)

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ClinicalTrials.gov Identifier: NCT01840033
Recruitment Status : Terminated (difficulty of selection of inclusion)
First Posted : April 25, 2013
Last Update Posted : February 2, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Tracking Information
First Submitted Date  ICMJE April 23, 2013
First Posted Date  ICMJE April 25, 2013
Last Update Posted Date February 2, 2018
Actual Study Start Date  ICMJE April 2013
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2013)
major complications [ Time Frame: 12 months ]
Statically significative difference between rate of incidence of major complications (infection and/or thrombosis related to catheter) during the 12 months follow-up.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01840033 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2013)
  • Delay [ Time Frame: 12 months ]
    Delay in days between insertion and first major complications
  • Questionnaire [ Time Frame: 12 months ]
    Questionnaire to evaluate catheter insertion by radiologist (satisfaction and complications). Satisfaction questionnaire to patients at every visit
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Monocenter Prospective Study to Evaluate the Efficacy of Peripherally Inserted Central Catheter to Tunnelled Central Catheter With Cuff in Home Parenteral Nutrition for Long-term Used.
Official Title  ICMJE A Monocenter Prospective Study to Evaluate the Efficacy of Peripherally Inserted Central Catheter to Tunnelled Central Catheter With Cuff in Home Parenteral Nutrition for Long-term Used: the PICCnut Study.
Brief Summary

Home parenteral nutrition (HPN) is the reference treatment for anatomic or fonctionnal chronic intestinal failure. Nutritionnal catheter must follow two rules: low infection rate and be able to preserve the permeability of the central vein. Today, in europeen guidelines, two types of central devices are recommended: tunnelled central catheter with cuff and implanted ports. However, their insertion is not without risk. Since many years, we have seen a new generation of catheter - peripherally inserted central catheter (PICC line)- which have many advantage over other central catheter. ESPEN guidelines accept the use of PICC line in short and moderate-term for HPN, but no prospective study have look for long-term used in HPN.

The objective of our study is to evaluate in a prospective randomised monocenter study the no-inferiority of PICC line to tunnelled central catheter with cuff for serious catheter related-complications such as infection and thrombophlebitis for patient on HPN over 1 month of duration. The secondary objectives are to: evaluate the number of patients with at least one serious complications related in 1000 days of used, the rate of minors and majors complications, number of catheter inserted, the satisfaction of patients and doctors.

The study is held in CHU Nice and will be proposed to hospitalized patients who will need HPN. After consent, patients will be randomized to receive PICC Line (group A) of nutritional central catheter with cuff (group B). Echography of vessels will be held at the beginning, 3 months and 12 months. Follow-up will be conduct at regular interval (month 0-1-3-6-9-12). The duration of follow-up will be of 12 months and the global duration of the study will be 36 months. One major complication will conduct to withdrawal of the study. There will be 55 patients in each group.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Chronic Intestinal Failure
Intervention  ICMJE
  • Device: group Piccnut
    Vessels echography will be systematically repeated at 3 months and 12 months for thrombosis research. Follow-up visit will be held at 1,3,6,9 and 12 months. At every step, major and minor complications will be noted by the investigators.
  • Device: Tunnelled nutritional central catheter
    After consent, patients will be randomised to PICC Line (group A) or tunnelled nutritional central catheter with cuff (group B). Duration of inclusion will be 24 months. After randomisation, patients will have catheter inserted by a competent radiologist following an echography. Radiologist will have to answer a questionnaire and doctors will note any catheter-related complications. After that, vessels echography will be systematically repeated at 3 months and 12 months for thrombosis research. Follow-up visit will be held at 1,3,6,9 and 12 months. At every step, major and minor complications will be noted by the investigators.
Study Arms  ICMJE
  • Active Comparator: Group B
    After consent, patients will be randomised to PICC Line (group A) or tunnelled nutritional central catheter with cuff (group B). Duration of inclusion will be 24 months. After randomisation, patients will have catheter inserted by a competent radiologist following an echography. Radiologist will have to answer a questionnaire and doctors will note any catheter-related complications.
    Intervention: Device: Tunnelled nutritional central catheter
  • Experimental: Group A
    PICC Line (group A) : patients will have catheter inserted by a competent radiologist following an echography. Radiologist will have to answer a questionnaire and doctors will note any catheter-related complications.
    Intervention: Device: group Piccnut
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 1, 2018)
7
Original Estimated Enrollment  ICMJE
 (submitted: April 23, 2013)
122
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • > 18 years-old
  • Patients managed by CHU Nice for home parenteral nutrition
  • Expected to have over 1 month of parenteral nutrition
  • Signed consent
  • Affiliation to Securite Social

Exclusion criteria

  • Patient with nutritional catheter before inclusion
  • Pregnancy or breastfeeding
  • Evolutive pathology with life expectancy < 12 months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01840033
Other Study ID Numbers  ICMJE 12-PP-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Hospitalier Universitaire de Nice
Study Sponsor  ICMJE Centre Hospitalier Universitaire de Nice
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: HEBUTERNE Xavier, PhD CHU de Nice, Hôpital Archet, Pôle Digestif, 151 route de saint-antoine de ginestière 06200 Nice
PRS Account Centre Hospitalier Universitaire de Nice
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP