Ignite Creation Date:
2024-05-06 @ 1:33 AM
Last Modification Date:
2024-10-26 @ 11:06 AM
Study NCT ID:
NCT01840033
Status:
TERMINATED
Last Update Posted:
2018-02-05
First Post:
2013-04-23
Brief 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
Sponsor:
Centre Hospitalier Universitaire de Nice
Organization:
Centre Hospitalier Universitaire de Nice
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
difficulty of selection of inclusion
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PICCNUT
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None