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.

Chronic Intestinal Failure Clinical Trial

— PICCNUT  

Official title:

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01840033
• Other study ID #: 12-PP-02
• Status: Terminated
• Phase: N/A
• First received: April 23, 2013
• Last updated: February 1, 2018
• Start date: April 2013
• Est. completion date: September 2014

Study information

• Verified date: January 2018
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Intestinal Failure

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	CHU de Nice	Nice	Alpes-Maritimes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	major complications	Statically significative difference between rate of incidence of major complications (infection and/or thrombosis related to catheter) during the 12 months follow-up.	12 months
Secondary	Delay	Delay in days between insertion and first major complications	12 months
Secondary	Questionnaire	Questionnaire to evaluate catheter insertion by radiologist (satisfaction and complications).; Satisfaction questionnaire to patients at every visit	12 months