Catheter Salvage in Intestinal Failure Patients

Study Overview
=================
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.

Official Title
-----------------
Catheter-related Bloodstream Infections in Patients With Intestinal Failure Receiving Home Parenteral Support: Risks Related to a Catheter-salvage-strategy.

Conditions
-----------------
Intestinal Failure, Catheter-Related Bloodstream Infection (CRBSI) Nos

Intervention / Treatment
-----------------
* Behavioral: catheter salvage


Participation Criteria
=================
Eligibility Criteria
-----------------
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| chronic intestinal failure patients<br>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. | Behavioral: catheter salvage<br>* In each case of catheter-related bloodstream infection the management of the central venous catheter was registred to evaluate the future risk of new infections<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| new catheter-related bloodstream infections | The occurrence of catheter-related bloodstream infection after either catheter salvaged (retained central venous catheter) or replaced central venous catheter (new central venous catheter) | 2002 to 2016 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrent catheter-related bloodstream infections | 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. | 2002 to 2016 | 
| relapse catheter-related bloodstream infection | 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. | 2002 to 2016 | 
| primary salvage rate | 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). | 2002 to 2016 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intestinal failure, catheter-related bloodstream infections, catheter salvage, recurrent infections, home parenteral support