Catheter Salvage in Intestinal Failure Patients

Completed

• Conditions: Catheter-Related Bloodstream Infection (CRBSI) Nos; Intestinal Failure
• Interventions: Behavioral: catheter salvage

• Registration Number: NCT03222232
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

This is an observational study evaluating a catheter salvage strategy in relation to catheter-related bloodstream infections in patients with chronic intestinal failure dependent on home parenteral support. The study is confined to the period 2002 to 2016.

Detailed Description

In chronic intestinal failure patients receiving home parenteral support (HPS), catheter-related bloodstream infections (CRBSIs) frequently results in replacement of their tunneled central venous catheters (CVCs) which may lead to future loss of central venous access.

This observational study investigates the consequences of a catheter-salvage-strategy related to CRBSIs according to different causative microorganisms, and short- and long-term risk of recurrence of the CRBSI. The study is based on the Copenhagen Intestinal failure database, which is a web-based database with retrospective data collection performed by reviews of medical charts from all adult intestinal failure patients discharged with home parenteral support from the Department of Medical Gastroenterology, Rigshospitalet.

Study Timeline

• Study Start: 2002-01-01
• Primary Completion: 2015-12-31
• Study Completion: 2015-12-31
• Status Verified: 2017-07
• Study First Submitted: 2017-07-16
• Study First Submitted QC: 2017-07-16
• Last Update Submitted: 2017-07-16
• Study First Posted: 2017-07-19
• Last Update Posted: 2017-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 715

Inclusion Criteria

• chronic intestinal failure dependent on home parenteral support and enrolled in the Copenhagen Intestinal failure database

Exclusion Criteria

• Never discharged on home parenteral support

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
chronic intestinal failure patients	catheter salvage	Patients with chronic intestinal failure on home parenteral support and enrolled in the Copenhagen Intestinal failure database between January 1, 2002 and December 31, 2015.

Primary Outcome Measures

Name	Time	Method
new catheter-related bloodstream infections	2002 to 2016	The occurrence of catheter-related bloodstream infection after either catheter salvaged (retained central venous catheter) or replaced central venous catheter (new central venous catheter)

Secondary Outcome Measures

Name	Time	Method
recurrent catheter-related bloodstream infections	2002 to 2016	A recurrent infection was defined as a CRBSI with identical microorganism and antibiogram occurring within 100 days of the previous CRBSI in a salvaged CVC.
relapse catheter-related bloodstream infection	2002 to 2016	A relapse infection was defined as recrudescence of the same causative microorganisms with identical antibiogram within 30 days of the previous CRBSI in a salvaged CVC.
primary salvage rate	2002 to 2016	The primary salvage rate was defined by the CVC status at hospital discharge. Because of the database setup and retrospective design of the study, all cases were included regardless of main reason to CVC removal (e.g. septic shock, severe sepsis, concomitant CVC problems and secondary or metastatic complications).

Trial Locations

Locations (1)

Rigshospitalet, abdominalcentret, Medicinsk Gastroenterologisk klinik CA, 2121; 🇩🇰 Copenhagen, Denmark