Catheter Salvage in Intestinal Failure Patients

Intestinal Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03222232
• Other study ID #: CVC salvage study
• Status: Completed
• Phase: N/A
• First received: July 16, 2017
• Last updated: July 16, 2017
• Start date: January 1, 2002
• Est. completion date: December 31, 2015

Study information

• Verified date: July 2017
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 715
• Est. completion date: December 31, 2015
• Est. primary completion date: December 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Catheter-Related Bloodstream Infection (CRBSI) Nos
• Communicable Diseases
• Infection
• Intestinal Failure

Intervention

Behavioral:
• catheter salvage
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

Locations

Country	Name	City	State
Denmark	Rigshospitalet, abdominalcentret, Medicinsk Gastroenterologisk klinik CA, 2121	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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